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Accommodating pain-free exercise therapy for peripheral arterial disease

University of Florida Institutional Repository

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ACCOMMODATING PAIN-FREE EXERCISE THERAPY FOR PERIPHERAL ARTERIAL DISEASE By COLEEN ARCHER A THESIS PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLOR IDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE UNIVERSITY OF FLORIDA 2006

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Copyright 2006 by Coleen Archer

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iii ACKNOWLEDGMENTS I would like to thank my husband, Oscar Ma rtinez, for all of his support throughout my research experience as well as through my graduate career. I of course would not even be here today if it was not for my w onderful mother, Debra Kilgore, my wonderful father, Bill Archer, my wonderful stepfather Pat Stinson, and my wonderful stepmother, Evonda Archer. I thank them tremendously. Finally, I would like to thank Dr. Christine Stopka and her family. Dr. Stopka has served as my professor and advisor. I could not have completed this thesis wit hout her guidance and support.

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iv TABLE OF CONTENTS page ACKNOWLEDGMENTS.................................................................................................iii LIST OF TABLES.............................................................................................................vi LIST OF FIGURES.........................................................................................................viii ABSTRACT....................................................................................................................... ix CHAPTER 1 INTRODUCTION........................................................................................................1 Definition of Terms......................................................................................................1 Literature Review.........................................................................................................2 Exercise....................................................................................................................... ..4 Near-Maximal Pain.......................................................................................................5 Accommodating Pain-Free (APF) Walking Exercise Therapy....................................6 Accommodating High and Low Intensity Training......................................................7 Pathophysiology...........................................................................................................7 Purpose........................................................................................................................ .9 2 MATERIALS AND METHODS...............................................................................10 Principal Investigator..................................................................................................10 Participants and Setting..............................................................................................10 Participants..........................................................................................................10 Instruments..........................................................................................................11 Exercise Settings.................................................................................................12 Procedures...................................................................................................................12 Treatment Protocol..............................................................................................13 Measures..............................................................................................................14 Research Design.........................................................................................................15 Variables..............................................................................................................15 The EP Dependent Variables (Exercise Performance)........................................15 Independent Variable...........................................................................................15 Data Analysis..............................................................................................................16 3 RESULTS...................................................................................................................18

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v Group A......................................................................................................................18 Total Distance Walked........................................................................................18 Total Duration Walked........................................................................................19 Total Walking Rate..............................................................................................20 Group B......................................................................................................................21 Total Distance Walked........................................................................................21 Total Duration Walked........................................................................................23 Total Walking Rate..............................................................................................24 Group C......................................................................................................................25 Total Distance Walked........................................................................................25 Total Duration Walked........................................................................................26 Total Walking Rate..............................................................................................27 4 DISCUSSION.............................................................................................................41 Group A......................................................................................................................41 Group B......................................................................................................................42 Group C......................................................................................................................42 Groups A, B, and C.....................................................................................................43 Limitations..................................................................................................................48 5 CONCLUSION AND FUTURE DIRECTIONS........................................................50 Conclusion..................................................................................................................50 Future Directions........................................................................................................50 APPENDIX A GOALS AND RATIONALE.....................................................................................52 B CLAUDICATION QUESTIONNAIRE.....................................................................53 C MEDICAL HISTORY QUESTIONNAIRE...............................................................54 D DEMOGRAPHIC INFORMATION..........................................................................56 E INFORMED CONSENT............................................................................................57 F THERAPEUTIC STRETCHES..................................................................................58 G EXERCISE TRAINING LOG....................................................................................60 LIST OF REFERENCES...................................................................................................61 BIOGRAPHICAL SKETCH.............................................................................................65

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vi LIST OF TABLES Table page 1. General characteristics of the study.........................................................................11 2. Intermittent claudi cation (IC) pain scale.................................................................17 3. Summary ANOVA for differences in pretest, midpoint, and post-test...................28 4. Ordered mean differences on the effects of the APF exercise................................29 5. Group A’s mean and standard deviation of distance (miles)..................................29 6. Summary ANOVA for differences in pretest, midpoint, and post-test...................30 7. Ordered mean differences on the effects of the APF walking................................30 8. Group A’s mean and standard devi ation of duration (minutes) walked..................31 9. Summary ANOVA for differences in pretest, midpoint, and post-test...................31 10. Ordered mean differences on the effects of the APF walking................................32 11. Group A’s mean and standard deviation of rate (mi/hr).........................................32 12. Summary ANOVA for differences in pretest, midpoint, post-test..........................33 13. Ordered mean differences on the effects APF walking...........................................33 14. Group B’s mean and standard deviation of distance (miles)...................................34 15. Summary ANOVA for differences in pretest, midpoint, and post-test...................34 16. Ordered mean differences on the effects of the APF..............................................35 17. Group B’s mean and standard deviation of duration (minutes)..............................35 18. Summary ANOVA for differences in pretest, midpoint, and post-test...................36 19. Ordered mean differences on the effects of the APF..............................................36 20. Group B’s mean and standard devi ation of rate (mi/hr) walked from....................37

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vii 21. Summary ANOVA for differences in pretest, midpoint, and post-test...................37 22. Ordered mean differences on the effects of the APF..............................................38 23. Group C’s mean and standard deviation of distance (miles)...................................38 24. Summary ANOVA for differences in pretest, midpoint, and post-test...................39 25. Ordered mean differences on the effects of the APF walking................................39 26. Group C’s mean and standard deviation of duration walked..................................40 27. Summary ANOVA for differences in pretest, midpoint, and post-test...................40 28. Group C’s mean and standard deviation of rate (mi/hr) walked.............................40

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viii LIST OF FIGURES Figure page 1. Effects of the APF walking exercise therapy for PAD on the.................................44 2. Effects of the APF walking exercise therapy for PAD on the amount....................45 3. Effects of the APF walking exercise therapy for PAD on the amount....................45

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ix Abstract of Thesis Presen ted to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Master of Science ACCOMMODATING PAIN-FREE EXERCISE THERAPY FOR PERIPHERAL ARTERIAL DISEASE By Coleen Archer August 2006 Chair: Christine E. Stopka-Boyd Major Department: Health Education and Behavior The purpose of this study was to determin e the effects of the accommodating painfree (APF) walking exercise th erapy program on exercise performance in patients with intermittent claudication (IC) due to peripheral arterial disease (PAD). The procedures of the study consisted of examin ing the improvements in walking performance before, during and after the implementation of the APF walking exercise therapy program. Group A (n = 28) participated in the program for two to nine weeks, group B (n = 30) participated in the program for 10-14 weeks, and group C (n = 26) participated in the program for 15-94 weeks. An average of the dependent variables from pretest to midpoint to post-test was calculated. The re search design used was a pretest post-test randomized group design for thr ee testing sessions. The depe ndent variable was exercise performance. The independent variable was the APF walking exercise therapy. Measurements taken include walking distance, walking duration, and walking rate. The protocol included the following: blood pressure and heart rate measurements taken before

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x and after walking, hold-relax pr oprioceptive neuromus cular facilitation stretching before and after walking, walking continually on a treadmill for 30 to 50 minutes below the participant’s individualized walking pain threshold, and a recording on the participant’s training log of total time and total distan ce walked. The statis tical program SPSS 12.0 was used to analyze the data and examine ch anges in the pretest, midpoint, and post-test walking performance variables using a repe ated measures design (ANOVA) with an alpha level of .05 to determine statistical signi ficance. If there was a significant F-value, the Tukey Post Hoc Test (TPHT) was used to determine further significance between the groups. All data are presented as mean, st andard deviation and percent improvement. The participants in Group A increased the am ount of distance, duration, and rate walked from pretest to post-test by 80% (p < .001), 27% (p < .001), and 37% (p < .001) respectively. The TPHT found a significant di fference between the post-test and pretest and between the midpoint and pretest. The pa rticipants in Group B increased the amount of distance, duration, and rate walked from pretest to post-test by 122% (p < .001), 56% (p < .001), and 43% (p < .001) respectively. The TPHT found a significant difference between the pretest and post-t est and pretest and midpoint va riables of both the distance and duration variables. The TP HT further revealed that ra te was significant from posttest to midpoint, post-test to pr etest, and midpoint to pretest. The participants in Group C increased the amount of distan ce, duration, and rate walked from pretest to post-test by 26% (p = .002), 22% (p = .002), and 5% (p = .541) respectively. The TPHT found a significant difference between the midpoint a nd pretest data of both the distance and duration variables. To achieve the best results in distance, duration, and rate improvements, a program of 10-14 weeks is the optimal length.

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1 CHAPTER 1 INTRODUCTION The purpose of this study was to determine the effects of the accommodating pain-free walking exercise therapy program on exercise performance in patients with intermittent claudication (IC) due to peri pheral arterial disease (PAD). The null hypothesis of this study was that the exercise program will not have an effect on exercise performance. The alternative hypothesis of this study was that the exercise program will have an effect on exercise performance. It is hypothesized that improvements in exercise performance will occur and hopefully reduce cardiovascular morbidity and mortality based on a review of the literature. Definition of Terms The following terms will be used frequen tly throughout the text, which are defined as follows: Accommodating pain-free (APF) refers to the exercise therapy protocol used in this study. The belief held by researchers is th at symptoms of periphe ral arterial disease (PAD) can be relieved by simply slowing down the walking speed at an individualized level. High-intensity exercise refers to walking on a treadmill at 80% maximum workload. Intermittent claudication (IC) refers to the symptom often felt by patients with PAD. It is essentially pain in the legs upon exertion.

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2 Low-intensity exercise refers to walking on a treadmill at 40% maximum workload. Near-maximal pain refers to walking on a treadmill to near-maximal pain tolerance, resting until pain subs ides, then resume walking. Peripheral arterial disease (PAD) refers to a disease that causes the peripheral arteries to become occluded and restrict blood flow. Literature Review The Centers for Disease Contro l (2005b) found that in 2002 there were 93,000 discharges of patients from hospitals in the United States listing peripheral arterial disease (PAD) as their fi rst-listed diagnosis. PAD consists of occlusions in the peripheral arteries of the legs and it affects approxi mately 8 million to 10 million people in the United States (Criqui, 2001; Stew art, Hiatt, Regensteiner, a nd Hirsch, 2002). PAD does not directly cause mortality but it is a manifestation of coronary and cerebrovascular disease which do cause mortality (Fuster, Mo reno, Fayad, Corti, and Badimon, 2005b). PAD is more specifically defined as a manifest ation of systemic atherothrombosis (Hiatt, 2004). Systemic atherothrombosis is an arte rial disease involving the intima (innermost coat of an organ consisting of an endothelial layer backed by connective tissue and elastic tissue) of large and medium sized arteries such as the carotid, aorta, coronary, and peripheral (Fuster, Moreno, Fayad, Corti, a nd Badimon, 2005a). The manifestation of this disease is defined as plaque build -up due to the following components: “1) connective tissue extracellular matrix, includi ng collagen, proteoglycan s, and fibronectin elastic fibers; 2) crystalline cholesterol, cholesteryl este rs, and phospholipids; 3) cells such as monocyte-derived m acrophages, T-lymphocytes, and smooth-muscle cells; and 4) thrombotic material with platelets and fi brin deposition” (Fuster et al., 2005a, p. 937).

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3 Hiatt (2004) clearl y explained how to identify PAD by taking blood pressure measurements in the ankles. A Doppler ultr asound device is used to obtain the systolic blood pressures in the posterio r tibial and dorsalis pedis vess els in the ankles and the brachial pressure in the arm. The value is a ratio of ankl e pressure to arm pressure. Values of < 0.90 are indicative of PAD. In other words, when the blood pressure in the ankle is lower than the blood pressure in th e arm, this indicates an occlusion in the peripheral arteries. Intermittent claudication (IC) is the earliest and most frequent presenting symptom of PAD that causes pain in the legs upon exertion (Ouriel, 2001). The pain is a result of ischemic conditions occurring due to low amounts of blood supply to the peripheral arteries during movement. Thirty pe rcent of patients with IC die within five years of the onset of symptoms (Carlon, Morlino, and Maiolino, 2003). Those with claudication have had myocardial infarction or stroke in 20% to 30% of cases and coronary disease in 50% to 70% of cases (Fuster et al., 2005b). In the United States, an estimated 1.3 million elderly individuals will develop IC every two years for the next 50 years (Kakkos, Geroulakos, and Nicolaides, 2005). IC is the most common new problem referred to vascular surgeons (Cheetham et al., 2004; Chong, Golledge, Greenhalgm, and Davies, 2000). Methods of managing IC include: lif estyle modifications, medications, surgery, and exercise. Lifestyle m odifications can include, but are not limited to, smoking cessation (Hiatt, 2004), diet modification, and we ight loss. Medications can include, but are not limited to, aspirin (antiplatelet therapy), statins ( lipid lowering ag ents) (Kakkos et al., 2005; Cheetham et al., 2004; Pasupat hy, Naseem, and Homer-Vanniasinkam, 2005;

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4 Hiatt, 2004), anti-hypertension, diabetic therapy (Cheetham et al., 2004; Hiatt, 2004), and proprionyl-L-carntitine (Hiatt 2004). Surgeries can incl ude, but are not limited to, bypass and percutaneous transluminal angiop lasty (PTA) (Krankenberg, Sorge, Zeller, and Tubler, 2005). Due to the underlying at herothrombosis that accompanies IC, many patients are not candidates for surgery because the surgery may present further complications. Exercises can include, but are not limited to, treadmill walking at an accommodating pain-free intensity (Barak, 2004; Boyd et al., 1984; Marburger, 1992; Martinez et al., 2005, Martinez, Stopka, and St radley, 2006; Stopka et al., 1998), low and high accommodating intensities (Slordahl et al., 2004; Gardner, Montgomery, Flinn, and Katzel, 2005) and non-accommodating high intens ities (Gardner and Poehlman, 1995). Heel raises and cycle ergometers have been used as methods of exercise (Ng, Hollingsworth, Luery, Kumana, and Chaloner, 2 005), as well as resistance training. Exercise Exercise is a common treatment of IC and the effects have been studied for decades. Exercise is considered one of the most effective interventions available for the treatment of IC (Carlon et al., 2003; Treat-Jacobson and Walsh, 2003). Several mechanisms are involved in this process: 1) peripheral blood fl ow redistribution, 2) inhibition of the progression of atherosclerosis, 3) favorable hematologic alterations 4) metabolic changes, 5) changes in musc le cell cytology and morphology, and 6) an increased pain threshold (Carlon et al.; Remijnse-Tamerius, Duprez, De Buyzere, Oeseburg, and Clement, 1999; Tan, De Cossart and Edwards, 2000). Walking is the preferred mode of exercise and improves the symptoms of claudication in several ways (Ekroth, Dahllof, Gundevall, Holm, and Schersten, 1978; Foley, 1957; Larsen and

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5 Lassen, 1966; Skinner and Strandness, 1967; Spronk, Dolman, Beolhouwer, Veen, and den Hoed, 2003). Near-Maximal Pain As a result of exte nsive literature searches pe rformed on PubMed and Science Direct databases using PAD and exercise as search words, it appears that the nearmaximal pain method is the most widely used walking exercise therapy to date. The belief held by many researchers and other medi cal professionals is th at symptoms of IC can be relieved by rest. Since the pain felt when walking is caused by an inadequate blood supply to the muscles during exercise, it is relieved when act ivity ceases (TreatJacobson et al., 2003). Therefore the walking therapy used by physicians and researchers calls for the patients to walk to ne ar-maximal pain tolerance, rest until pain subsides, and then resume walking (Carl on et al., 2003; Gardner and Poehlman, 1995; Hiatt, Regensteiner, Hargarten, Wolfel, a nd Brass, 1990; Hiatt, Wolfel, Meier, and Regensteiner, 1994; Izquierdo-Porrera, Gar dner, Powell, and Katzel, 2000; Lundgren, Dahllof, Schersten, and Bylund-Fellen siu, 1989; Mannarino, Pasqualino, Menna, Maragoni, and Orlandi, 1989; Santilli, Rodnick, and Santilli, 1996). Exercise therapy us ed by Izquierdo-Porrera et al (2000) required patients to walk at 2 mph until their pain reached a leve l 3 on a 0 to 4 pain scale (0 = no pain, 1 = onset of pain, 2 = moderate pain, 3 = intens e pain, and 4 = maximal pain), after which they rested. Five minutes of cycling on a st ationary bicycle were used as warm-up and cool down in each session. It is important to note that the American College of Sports Medicine (ACSM) recommends the use of a maximal pain method as the only exercise therapy for the treatment of IC (Mahler, Froe licher, Miller, and York, 1995).

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6 Accommodating Pain-Free (APF) Walking Exercise Therapy Accommodating pain-free (APF) walk ing exercise therapy for IC has recently been introduced as an alternative method for walking exercise ther apy (Martinez et al., 2006). The belief held by researchers and othe r medical professionals is that symptoms of IC can be relieved by simply slowing down the participant’s walking speed. Many authors suspect that exercise beyond the pain threshold might worsen blood flow or that ischemia might induce the inflammation-mediat ed progression of atherosclerosis (Carlon et al., 2003; Tisi and Shearma n, 1998; Turton et al., 1998). Those who use the accommodating pa in-free method believe that further stress on the arteries through a near-maximal pain walking therapy may only exacerbate other underlying conditions such as cardiovascular ev ents. For example, Carlon et al. (2003) used the near-maximal pain therapy and excl uded one patient because of their onset of heart failure during the 10th exercise sessi on. But the objective to involve oxidative tissue through continuous aerobi c training, plus the logic of more motivation and less risky training has allowed for the emerge nce of an alternative training method. This method, which was used in this study, calls for the patients to walk below their maximal pain tolerance, slow down their walking when pain is barely felt, and then increase their walking speed when the pain is no longer felt (Barak, 2004; Boyd et al., 1984; Marburger, 1992; Martinez et al., 2005; Stopka et al., 1998). Specifically, the exercise thera py used by Martinez et al. (2005) required patients to walk continuously on a treadmill at a comfortable speed until their legs reached an uncomfortable level of 0.5 on a 0 to 4 pain scale (0 = no symptoms, 0.5 = tiredness, heaviness or tightness in legs without pain, 1 = tigh tness with definite, but mild pain, 2 = starting to hurt with moderate, but distractible pai n, 3 = definitely hurts with

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7 severe, nondistractible pain, and 4 = must st op now with excruciating, unbearable pain) after which they slowed down but did not stop walking. The patients were instructed to walk as fast as possible without pain. When the patients felt pa in they were instructed to slow down their walking speed on the treadm ill until they no longer felt pain. Once the patients’ pain had diminished they were inst ructed to increase their walking speed, again. This process was repeated throughout the ex ercise session, comforta ble training speeds after the slower recovery wa lking, typically reach speeds higher than what had just elicited the pain response. Accommodating High and Low Intensity Training Recent studies by Gardner et al. (2005) and Slordahl et al. (2004) have investigated low-intensity versus high-intensi ty walking therapy. Ga rdner et al. defined low-intensity as 40% of the participant’s maximal workload while high-intensity was defined as 80% of the participant’s maximal workload. The therapy Gardner et al. used remains unclear if an accommodating appro ach was used during exercise sessions. However, Slordahl et al. defi ned low-intensity and high-intensity exactly the same as the previous Gardner et al. example, but did clearly use an accommodating approach to the exercise sessions, “since VO2 peak and work economy adapt to training, the work load had to be adjusted during the training period to maintain the relative intensity level” (p. 246). But overall, these methods seem very similar to the near-maximal pain therapy discussed above. Pathophysiology The interaction between the muscles and their much needed blood supply is very specific. Factors such as muscle phenotype, muscle me tabolic demands, arterial thrombus formation, and arterial platelet activation are all ve ry important factors in the

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8 pathophysiology of the PAD. Understanding the pathophys iology behind PAD allows researchers to relate improved fitness to other factors such as improved muscular efficiency/oxygen use unlike the opinion of Ng et al. (2005) who believed that the pathophysiology in improved fitness needed to remain a separate issue. Askew et al. (2005) found that muscle phenotype is altere d when patients with PAD are compared with non-PAD controls. Spec ifically patients with PAD have a lower amount of type I muscle fibers. Type I muscle fibers are classified as endurance fibers; they are fatigue resistant and are found to be in great demand during marathons for example. Unfortunately what patients w ith PAD have been shown to have are high amounts of type II fibers. Type II fibers ar e used for a burst of energy such as a 100 meter track race. Type II fibers lead to fati gue and ultimately pain if used for a prolong period of time. This finding explains why a person with IC feels pa in when walking. Hiatt (2004) stated that blood fl ow can’t meet the metabolic demand of the muscles in patients with IC. He stated that an increase in the le vel of acylcarnitine in blood plasma of claudicants would indicate a metabolic disruption. Acyl-coenzyme A (CoA) is an intermediate used in the Kreb’s cycle for complete oxidation. An accumulation of acyl-CoA would indicate incomple te oxidation or incomplete utilization. Hiatt determined that a supplement of propri onyl-L-carnitine would aid in the treatment of IC by supplying needed nutrients to sati sfy the metabolic demand of the muscles. Killewich, Macko, Montgomery, W iley, and Gardner (2004) stated that “progression of atherosclerosi s is also associated with thrombus formation” (p. 741) which in turn reduces endogenous fibrinolysis. Fibrinolysis is “the system by which the body lyses excess or inappropria tely formed thrombus” (p. 741). Killewich et al.

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9 determined that patients with PAD have im paired fibrinolytic activity but exercise training reduced these impairments. Sp ecifically exercise can increase tissue plasminogen activator activity (tPA) and d ecrease plasminogen act ivator inhibitor-1 activity (PAI-1) which will in turn allow the body to lyse the thrombus formation and essentially reduce the plaque build up in the peripheral arteries. Pasupathy et al. (200 4) stated that “exercise appears to induce an inflammatory response in patients with cla udication” (p. 50). High leve ls of platelet-leucocyte aggregation (PLA) and plat elet-neutrophil aggregation (PNA) may contribute to morbidity and mortality in patients with PAD. The authors determined that levels of PLA and PNA are increased after exercise in patien ts with claudication but diminished when a warm-up was used. A warm-up was shown to delay claudication pain and therefore improve the overall exercise capacity of th e patients in the study. Clearly, further study comparing low intensity training (eg. APF) to the currently recommended high intensity (eg. Near-maximal pain) training on the in flammatory response is indicated. Purpose The purpose of this study was to determine the effects of the accommodating pain-free (APF) walking exercise therapy pr ogram on exercise performance in patients with intermittent claudication (IC) due to pe ripheral arterial disease (PAD). The null hypothesis of this study was that the exercise program will not have an effect on exercise performance. The alternative hypothesis of this study was that the exercise program will have an effect on exercise performance. It is hypothesized that improvements in exercise performance will occur and hopefully reduce cardiovascular morbidity and mortality based on a review of the literature.

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10 CHAPTER 2 MATERIALS AND METHODS Principal Investigator The principal investigator (P.I.) for this study has accumulated over 2400 hours working with a variety of aspects co ncerning the accommodating pain-free (APF) walking exercise therapy program. The P. I. began her involvement in 2003 when the program was implemented at Fit for Life Fitne ss Center, Inc. From that point on, the P.I. has been involved with patient trainin g, volunteer training, data compilation, data analysis, and submission of written and oral reports about the program. The P.I. was personally involved with at least 20 of the part icipants in this study and the rest of the data was collected by the research supervisor. It is important to not e that this study is a branch of a larger study that has been conducted for 25 years by the same research supervisor. Participants and Setting Participants All participants were referred from Gainesville, FL and Charlottesville, VA area vascular surgeons and were screened for hear t disease and found to have a present history of peripheral arterial diseas e (PAD) with symptoms of in termittent claudication (IC). The participants were recruited between 1980 and 2005 (1980-2003; research supervisor’s data and 2003-2005; P.I.’s data). Table 1 provides the general characteristics of the study population.

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11 The protocols for this study were a pproved by the Institutional Review Board at the University of Florida and the University of Virginia to protect the rights and welfare of the human participants involved. The part icipants were counsel ed on their rights as well as potential risks and bene fits of the program, prior to signing an informed consent form. Table 1. General characteristics of the study population (n = 84) M SD Age (years) 68.73 9.19 Diabetes (%) 27.4 Female (%) 34.5 Heart Disease (%) 41.70 Hypercholesterol (%) 19 Hypertension (%) 47.6 Smoker (%) 12 Stroke (%) 7 Weeks in program 17 17 Instruments The instruments used in the st udy consisted of the following: Treadmills : in the following fitness centers: Fit for Life Fitness Center, Inc., Gainesville, FL and Living Well at the Univers ity of Florida, Gainesville, FL. Treadmills at a University of Virginia research lab were also used. The treadmill speed began at 0.1 mph and increased in increments of 0.1 mph to a maximum speed of 12 mph. Blood pressure equipment : standing, calibrated, manual aneroid manometer. The blood pressure was measured in a seated position on the left upper arm with the palm of the hand facing up.

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12 Heart rate : to determine heart rate, the manual radial method was employed. The heart rate was measured in a seated posit ion on the left forearm just below the left wrist. A 10-s pulse count was performed and the digit outcome was multiplied by 6 to determine the participant’s heart rate. Exercise Settings The APF walking exercise therapy program took place at Fit for Life Fitness Center, Inc., Gainesville, FL, Living Well at th e University of Florida, Gainesville, FL, and at the Applied Physiology Laboratory in the Center fo r Physical Fitness at the University of Virginia. Procedures The procedures of the study consiste d of examining the improvement in walking performance before, during and after the im plementation of the APF walking exercise therapy program. Group A (n = 28) participat ed in the program for two to nine weeks, group B (n = 30) participated in the progr am for 10-14 weeks, and group C (n = 26) participated in the program for 15-94 weeks. The participants were notified by th eir physicians about the study. On the very first day of the treatment program, the part icipants were oriented on the treatment program goals and the rationales were carefully explained. Written copies of the goals and rationale were given to the participan ts for their records (see Appendix A). The participants then completed the Claudicati on Questionnaire to assess and document the nature of their pain (see Appendix B). The participants also completed a Medical History Questionnaire from the therapy facility to evaluate the safety of the participants’ involvement in an exercise program (see A ppendix C). Further demographic information was also obtained for administrative purpos es (see Appendix D). Finally, if the

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13 participants were still interest ed in joining the exercise program, they were instructed to read and sign the Informed Consent form (see Appendix E). The participants kept a signed Informed Consent form for their records and a signed Informed Consent form was kept in their files at the therapy facility. Upon completion of the treatment or ientation, the first exercise session was conducted. It was made very clear that th e program once started could be discontinued by the participants at any time and that the program was free of charge for the first six weeks of treatment. Following the first six weeks of treatment, the participants were asked to become a member of Fit for Life Fitness Center, Inc. or pay a guest fee to continue with the accommodating pain-free wa lking exercise therapy program. The participants were not asked to become memb ers at the other therapy facilities. Treatment Protocol The treatment protocol used in this study was the APF Walking Exercise Therapy for PAD where the IC symptoms can be relieved by simply slowing down the participant’s walking speed (Martinez et al., 2006). At the beginning of each treatme nt session blood pressure and heart rate measurements were conducted. Immediat ely before walking on the treadmill, the participants actively participated in a series of therapeutic stretche s with the contraction enhancing hold-relax method of proprioceptiv e neuromuscular facilitation (PNF) (see Appendix F). The purpose of the therapeutic st retches was to help relax the muscles and prevent injury from the treadmill regimen, as well as to treat any pre-existing muscular imbalances, hypertonias, etc. The participants walked on a tr eadmill immediately af ter stretching. The participants began and ended with a warm-up and cool dow n phase respectively. Each

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14 phase lasted approximately 7 minutes. Th e warm-up and cool down phase consisted of walking at a slow rate when compared to th e participant’s “normal speed.” After a warm up, the speed of the treadmill was increased by increments of 0.1 mph or 0.2 mph in 5 to 7 minute intervals. The participants found an optimal speed of the treadmill and stayed at that speed for 10-15 minutes. When IC pain was felt by the participants to a degree of 0.5 to 1 on the IC Pain Scale (see Table 2) the speed of the treadmill was reduced by approximately 0.5 mph. The participants con tinued to walk with the reduced speed until the symptoms of IC pain diminished. Time until the pain diminished varied from 1 to 5 minutes. When the pain diminished, the treadmill speed gradually increased until the participants were walking 0.1 m ph, or higher, than the original speed that elicited the IC symptoms. This speed adjustment protocol continued throughout the session to ensure that the participants were always walking at their optimal (aerobic, continuous) training rate (as fast as possible without pain). An accommodating intensity walking cool down ended the walking session. The walking sessions ranged from 30 to 50 minutes. The exercise sessions were conducted twice a week for approximately 60 minutes. The data obtained before, during, and afte r the exercise session were recorded on an exercise training log (see Appendix G). Measures The measure used in the study consisted of the following: 1. Pretest: Average of first and second session 2. Midpoint: Average of first and second midpoint session 3. Post-test: Average of next to last and last session 4. Walking rate (mi/hr): total distance / total duration 5. Percent improvement: (post exercise value – pre exercise value) / pre exercise value x 100

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15 Research Design Observations were obtained during each treatment meeting of the participants. An average of the dependent variables fr om pretest to midpoint to post-test was calculated. The research design used was a pretest post-test randomized group design for three testing sessions. Variables The purpose of this study was to determine the effects of the accommodating pain-free walking exercise therapy program on exercise performance in patients with IC due to PAD. To investigate this question, EP (exercise performance) served as the dependent variable and was measured on an interval/ratio scale. The APF walking exercise therapy served as the indepe ndent variable and was measured on a nominal/ordinal scale. The EP Dependent Variable s (Exercise Performance) To examine the changes throughout the treatment program the following EP variables were analyzed: Walking distance : recorded directly from the treadmill’s screen at the end of the exercise. Walking duration : recorded directly from the treadmill’s screen at the end of the exercise session. Walking rate : was calculated using the data obtained from the previous two variables. Independent Variable The independent variable used in the study consisted of the APF Walking Exercise Therapy program (Martinez et al., 2006).

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16 Data Analysis The general characteristics of th e study population (see Tabl e 1) were generated from Epi Info Version 3.3.2. Epi Info is a computer program used by epidemiologists and other public health and medical professionals to ra pidly develop questionnaires, customize the data entry process, and ente r and analyze data (Centers for Disease Control, 2005a) The statistical program SPSS 12.0 wa s used to analyze the data and examine changes in the pretest, midpoint, and post-te st walking performan ce variables using a repeated measures design (ANOVA) with an alpha level of 0.05 to determine statistical significance. If there was a significant F-value, the Tukey Post Hoc Test was used to determine further significance between the groups. Repeated measures ANOVA was used due to the following assumptions: the m eans were acquired with random selection, the data was normally distributed, the sample means and sample standard deviations were known, the population standard deviations and means were not known, the dependent variable was on an interval/ratio scale, and the independent variable was on a nominal/ordinal scale. Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy program. Ha: 1 2 3; there will be a difference between improvements in exercise performance and the APF exercise therapy program. All data are presente d as mean, standard deviation and percent improvement.

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17 Table 2. Intermittent claudication (IC) pain scale 0 NO SYMPTOMS 0.5 TIREDNESS, HEAVINESS OR TIGHTNESS IN LEGS without pain 1 TIGHTNESS with definite, but mild pain 2 STARTING TO HURT with moderate, but distractible pain 3 DEFINITELY HURTS with severe, nondistractible pain 4 MUST STOP NOW with excruciating, unbearable pain Note: From Stopka et al.,1998

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18 CHAPTER 3 RESULTS Group A Group A (n = 28) participated in the program for 2 to 9 weeks. Total Distance Walked Table 3 provides a summary of the repeated measures ANOVA test. The critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| 3.17. F was equal to 30.45, therefore the F-value is greater than the cr itical region, 30.45 3.17. The null hypothesis was rejected, Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the accommodating pain-free (APF) exercise therapy program. The alternative hypothesis was assumed, Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Table 4 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test found that T = .15. The mean difference of the post-test and pretest was greater than the T-value, .47 > .15, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exer cise therapy program. Assume Ha: 1 2 3; there is a difference between improveme nts in exercise performance and the APF exercise therapy program. The mean differe nce of the midpoint and pretest was greater than the T-value, .37 > .15, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and th e APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance

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19 and the APF exercise therapy program. Th e mean difference of the post-test and midpoint was less than the T-value, .1 < .15, reject Ha: 1 2 3; there is a difference between improvements in exercise performan ce and the APF exercise therapy program. Assume Ho: 1 = 2 = 3; there is no di fference between improvements in exercise performance and the APF exercise therapy program. Table 5 provides a summary of the pret est, midpoint, and post-test means and standard deviations. The mean pretest di stance was .59 miles while the mean midpoint distance was .96 miles, and the mean post-test distance was 1.06 miles. The repeated measures ANOVA and Tukey Post Hoc Test found that the difference between the posttest and pretest distance and the midpoint and pretest distance was significant. Total Duration Walked Table 6 provides a summary of the re peated measures ANOVA test. The critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| 3.17. F was equal to 15.34, therefore the F-value is grea ter than the critical region, 15.34 3.17. The null hypothesis was rejected, Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy program. The alternative hypothesis was assumed, Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Table 7 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test found that T = 4.42. The mean differen ce of the post-test and pretest was greater than the T-value, 9.78 > 4.42, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and th e APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. The mean difference of the midpoint and pretest

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20 was greater than the T-value, 7.16 > 4.42, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performan ce and the APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy prog ram. The mean difference of the post-test and midpoint was less than the T-value, 2.62 < 4.42, reject Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Assume Ho: 1 = 2 = 3; ther e is no difference between improvements in exercise performance and the APF exercise therapy program. Table 8 provides a summary of the pret est, midpoint, and post-test means and standard deviations. The mean pretes t duration was 25.95 minutes while the mean midpoint duration was 33.11 minutes, and the m ean post-test duration was 35.73 minutes. The repeated measures ANO VA and Tukey Post Hoc Test found that the difference between the post-test and pretest duration and the midpoint and pretest duration was significant. Total Walking Rate Table 9 provides a summary of the re peated measures ANOVA test. The critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| 3.17. F was equal to 14.64, therefore the F-value is grea ter than the critical region, 14.64 3.17. The null hypothesis was rejected, Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy program. The alternative hypothesis was assumed, Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Table 10 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test found that T = .27. The mean difference of the post-test and pretest was greater than

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21 the T-value, .48 > .27, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and th e APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. The mean difference of the midpoint and pretest was greater than the T-value, .33 > .27, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performan ce and the APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy prog ram. The mean difference of the post-test and midpoint was less than the Tvalue, .15 < .27, reject Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Assume Ho: 1 = 2 = 3; ther e is no difference between improvements in exercise performance and the APF exercise therapy program. Table 11 provides a summary of the pretest, midpoint, and post-test means and standard deviations. The mean pretest rate was 1.31 mi/hr while th e mean midpoint rate was 1.64 mi/hr, and the mean post-test rate was 1.8 mi/hr. The repeated measures ANOVA and Tukey Post Hoc Test found that the difference between the post-test and pretest rate and the midpoint a nd pretest rate was significant. Group B Group B (n = 30) participated in the program for 10 to 14 weeks. Total Distance Walked Table 12 provides a summary of the repeated m easures ANOVA test. The critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| 3.17. F was equal to 34.32, therefore the F-value is greater than the cr itical region, 34.32 3.17. The null hypothesis was rejected, Ho: 1 = 2 = 3; there is no difference between

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22 improvements in exercise performance and the APF exercise therapy program. The alternative hypothesis was assumed, Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Table 13 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test found that T = .2. The mean difference of the post-test and pretest was greater than the T-value, .62 > .2, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and th e APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. The mean difference of the midpoint and pretest was greater than the T-value, .56 > .2, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performan ce and the APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy prog ram. The mean difference of the post-test and midpoint was less than the T-value, .06 < .2, reject Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Assume Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy program. Table 14 provides a summary of the pretest, midpoint, and post-test means and standard deviations. The mean pretest di stance was .51 miles while the mean midpoint distance was 1.07 miles, and the mean post-te st distance was 1.13 mile s. The repeated measures ANOVA and Tukey Post Hoc Test found that the difference between the posttest and pretest distance a nd the midpoint and pretest distance was significant.

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23 Total Duration Walked Table 15 provides a su mmary of the repeated m easures ANOVA test. The critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| 3.17. F was equal to 25.91, therefore the F-value is greater than the cr itical region, 25.91 3.17. The null hypothesis was rejected, Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy program. The alternative hypothesis was assumed, Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Table 16 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test found that T = 4.99. The mean differen ce of the post-test and pretest was greater than the T-value, 11.14 > 4.99, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and th e APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. The mean difference of the midpoint and pretest was greater than the T-value, 14.09 > 4.99, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performan ce and the APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy prog ram. The mean difference of the post-test and midpoint was less than the T-va lue, -2.95 < 4.99, reject Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Assume Ho: 1 = 2 = 3; ther e is no difference between improvements in exercise performance and the APF exercise therapy program. Table 17 provides a summary of the pretest, midpoint, and post-test means and standard deviations. The mean pretes t duration was 19.73 minutes while the mean

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24 midpoint duration was 33.82 minutes, and the m ean post-test duration was 30.87 minutes. The repeated measures ANO VA and Tukey Post Hoc Test found that the difference between the post-test and pretest duration and the midpoint and pretest duration was significant. Total Walking Rate Table 18 provides a su mmary of the repeated m easures ANOVA test. The critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| 3.17. F was equal to 26.53, therefore the F-value is greater than the cr itical region, 26.53 3.17. The null hypothesis was rejected, Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy program. The alternative hypothesis was assumed, Ha: 1 2 3; there is a difference between improvements in exercise performance a nd the APF exercise therapy program. Table 19 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test found that T = .22. The mean difference of the post-test and pretest was greater than the T-value, .64 > .22, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and th e APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. The mean difference of the midpoint and pretest was greater than the T-value, .36 > .22, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performan ce and the APF exercise therapy program. Assume Ha: 1 2 3; there is a difference betw een improvements in exercise performance and the APF exercise therapy prog ram. The mean difference of the post-test and midpoint was greater than the T-value, .28 >.22, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy

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25 program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Table 20 provides a summary of the pretest, midpoint, and post-test means and standard deviations. The mean pretest rate was 1.48 mi/hr while th e mean midpoint rate was 1.84 mi/hr, and the mean post-test rate was 2.12 mi/hr. The repeated measures ANOVA and Tukey Post Hoc Test found that the difference between the post-test and pretest rate and the midpoint and pretest ra te and the post-test and midpoint rate was significant. Group C Group C (n = 26) participated in the program for 15 to 94 weeks. Total Distance Walked Table 21 provides a summary of the repeated m easures ANOVA test. The critical value (C.V.) was F = 3.18 and the critical region (C.R.) was |F| 3.18. F was equal to 7.4, therefore th e F-value is greater than the critical region, 7.4 3.18. The null hypothesis was rejected, Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy program. The alternative hypothesis was assumed, Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Table 22 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test found that T = .22. The mean difference of the post-test and pretest was less than the T-value, .19 < .22, reject Ha: 1 2 3; there is a difference between improvements in exercise performance and th e APF exercise therapy program. Assume Ho: 1 = 2 = 3; there is no difference be tween improvements in exercise performance and the APF exercise therapy program. The mean difference of the midpoint and pretest

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26 was greater than the T-value, .35 > .22, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performan ce and the APF exercise therapy program. Assume Ha: 1 2 3; there is a difference betw een improvements in exercise performance and the APF exercise therapy prog ram. The mean difference of the post-test and midpoint was less than the T-va lue, -.16 < .22, reject Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Assume Ho: 1 = 2 = 3; ther e is no difference between improvements in exercise performance and the APF exercise therapy program. Table 23 provides a summary of the pretest, midpoint, and post-test means and standard deviations. The mean pretest di stance was .72 miles while the mean midpoint distance was 1.07 miles, and the mean post-test distance was .91 miles. The repeated measures ANOVA and Tukey Post Hoc Test found that the difference between the midpoint and pretest distance was significant. Total Duration Walked Table 24 provides a summary of the repeated m easures ANOVA test. The critical value (C.V.) was F = 3.18 and the critical region (C.R.) was |F| 3.18. F was equal to 6.9, therefore th e F-value is greater than the critical region, 6.9 3.18. The null hypothesis was rejected, Ho: 1 = 2 = 3; there is no difference between improvements in exercise performance and the APF exercise therapy program. The alternative hypothesis was assumed, Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Table 25 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test found that T = 5.72. The mean difference of the post-test and pretest was less than the T-value, 5.1 < 5.72, reject Ha: 1 2 3; there is a difference between

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27 improvements in exercise performance and th e APF exercise therapy program. Assume Ho: 1 = 2 = 3; there is no difference be tween improvements in exercise performance and the APF exercise therapy program. The mean difference of the midpoint and pretest was greater than the T-value, 8.74 > 5.72, reject Ho: 1 = 2 = 3; there is no difference between improvements in exercise performan ce and the APF exercise therapy program. Assume Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy prog ram. The mean difference of the post-test and midpoint was less than the T-va lue, -3.64 < 5.72, reject Ha: 1 2 3; there is a difference between improvements in exercise performance and the APF exercise therapy program. Assume Ho: 1 = 2 = 3; ther e is no difference between improvements in exercise performance and the APF exercise therapy program. Table 26 provides a summary of the pretest, midpoint, and post-test means and standard deviations. The mean pretes t duration was 22.82 minutes while the mean midpoint duration was 31.56 minutes, and the m ean post-test duration was 27.92 minutes. The repeated measures ANO VA and Tukey Post Hoc Test found that the difference between the midpoint and pretest duration was significant. Total Walking Rate Table 27 provides a summary of the repeated m easures ANOVA test. The critical value (C.V.) was F = 3.18 and the critical region (C.R.) was |F| 3.18. F was equal to .62, therefore the F-value is less than the critical region, .62 < 3.18. The alternative hypothesis was rejected, Ha: 1 2 3; there is a difference between improvements in exercise performance and th e APF exercise therapy program. The null hypothesis was assumed, Ho: 1 = 2 = 3; th ere is no difference between improvements in exercise performance and the APF exercise therapy program.

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28 Table 28 provides a summary of the pretest, midpoint, and post-test means and standard deviations. The mean pretest rate was 1.8 mi/hr while the mean midpoint rate was 1.92 mi/hr, and the mean post-test rate was 1.89 mi/hr. The repeated measures ANOVA test found that the difference between the post-test, midpoint, and pretest rate was not significant. Table 3. Summary ANOVA for differences in pretest, midpoint, and post-test distance (miles) markers in the APF walk ing exercise therapy for PAD. Group A Source SS df MS F Treat 3.42 2 1.71 30.45* Within 17.23 81 0.21 Between Subjects 14.21270.53 Error 3.03540.06 Total 20.65 83 *p < .05; F(.05) = 3.17

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29 Table 4. Ordered mean differences on the effects of the APF exercise walking therapy for PAD on group A distance (miles) performance using a Tukey Post Hoc Test Group Means (distance walked) Post-test Midpoint Pretest Mean Diff 1.06 0.96 0.1 1.06 0.59 0.47* 0.96 0.59 0.37* *p < .05; T(.05) = .15 Table 5. Group A’s mean and standard deviation of distance (miles) walked from pretest, midpoint, to post-test. Pre MP Post M 0.59 0.96 1.06 SD 0.35 0.53 0.49

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30 Table 6. Summary ANOVA for differences in pretest, midpoint, and post-test duration (minutes) markers in the APF wa lking exercise therapy for PAD. Group A Source SS df MS F Treat 1436 2 718 15.34* Within 8305 81 102 Between Subjects 577627214 Error 25295446.84 Total 9741 83 *p < .05; F(.05) = 3.17 Table 7. Ordered mean differences on the effects of the APF walking exercise therapy for PAD on dur ation (minutes) performance using a Tukey Post Hoc Test. Group A Group Means (duration walked) Post-test Midpoint Pretest Mean Diff 35.73 33.11 2.62 35.73 25.95 9.78* 33.11 25.95 7.16* *p < .05; T(.05) = 4.42

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31 Table 8. Group A’s mean and standard de viation of duration (minutes) walked From pretest, midpoint, to post-test. Pre MP Post M 25.95 33.11 35.73 SD 8 10.56 11.49 Table 9. Summary ANOVA for differences in pretest, midpoint, and post-test rate (mi/hr) markers in the APF walki ng exercise therapy for PAD. Group A Source SS df MS F Treat 3.46 2 1.73 14.64* Within 26 81 0.33 Between Subjects 20270.75 Error 6.38540.19 Total 29.46 83 *p < .05; F(.05) = 3.17

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32 Table 10. Ordered mean differences on the effects of the APF walking exercise therapy for PAD on gr oup A rate (mi/hr) performance using a Tukey Post Hoc Test Group Means (walking rate) Post-test Midpoint Pretest Mean Diff 1.79 1.64 0.15 1.79 1.31 0.48* 1.64 1.31 0.33* *p < .05; T(.05) = .27 Table 11. Group A’s mean and standa rd deviation of rate (mi/hr) walked from pretest, midpoint, to post-test. Pre MP Post M 1.31 1.64 1.8 SD 0.55 0.6 0.57

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33 Table 12. Summary ANOVA for differences in pretest, midpoint, post-test distance (miles) markers in the APF walk ing exercise therapy for PAD. Group B Source SS df MS F Treat 7.08 2 3.54 34.32* Within 21.94 87 0.25 Between Subjects 15.95290.55 Error 5.98580.1 Total 29.02 89 *p < .05; F(.05) = 3.17 Table 13. Ordered mean differences on the effects APF walking exercise therapy for PAD on group B distance (miles) performance using a Tukey Post Hoc Test Group Means (walking distance) Post-test Midpoint Pretest Mean Diff 1.13 1.07 0.06 1.13 0.51 0.62* 1.07 0.51 0.56* *p < .05; T(.05) = .2

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34 Table 14. Group B’s mean and standard deviation of distance (miles) walked from pretest, midpoint, to post-test. Pre MP Post M 0.51 1.07 1.13 SD 0.31 0.55 0.6 Table 15. Summary ANOVA for differences in pretest, midpoint, and post-test duration (minutes) markers in the APF wa lking exercise therapy for PAD. Group B Source SS df MS F Treat 3310 2 1655 25.91* Within 9654 87 110 Between Subjects 5949.5629205 Error 37055863.89 Total 12964 89 *p < .05; F(.05) = 3.17

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35 Table 16. Ordered mean differences on the effects of the APF walking exercise therapy for P AD on group B duration (minutes) performance using a Tukey Post Hoc Test Group Means (walking duration) Post-test Midpoint Pretest Mean Diff 30.87 33.82 -2.95 30.87 19.73 11.14* 33.82 19.73 14.09* *p < .05; T(.05) = 4.99 Table 17. Group B’s mean and standard deviation of duration (minutes) walked from pretest, midpoint, to post-test. Pre MP Post M 19.73 33.82 30.87 SD 7.61 11.89 11.56

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36 Table 18. Summary ANOVA for differences in pretest, midpoint, and post-test rate (mi/hr) markers in the APF walki ng exercise therapy for PAD. Group B Source SS df MS F Treat 6.09 2 3.04 26.53* Within 33.78 87 0.39 Between Subjects 27290.94 Error 6.66580.12 Total 39.87 89 *p < .05; F(.05) = 3.17 Table 19. Ordered mean differences on the effects of the APF walking exercise therapy for PAD on group B rate (mi/hr) performance using a Tukey Post Hoc Test Group Means (walking rate) Post-test Midpoint Pretest Mean Diff 2.12 1.84 0.28* 2.12 1.48 0.64* 1.84 1.48 0.36* *p < .05; T(.05) = .22

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37 Table 20. Group B’s mean and standard de viation of rate (mi/hr) walked from pretest, midpoint, to post-test. Pre MP Post M 19.73 33.82 30.87 SD 7.61 11.89 11.56 Table 21. Summary ANOVA for differences in pretest, midpoint, and post-test distance (miles) markers in the APF walk ing exercise therapy for PAD. Group C Source SS df MS F Treat 1.59 2 0.79 7.4* Within 23.33 75 0.31 Between Subjects 17.97250.72 Error 5.37500.11 Total 24.92 77 *p < .05; F(.05) = 3.18

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38 Table 22. Ordered mean differences on the effects of the APF walking exercise therapy for PAD on group C distance (miles) performance using a Tukey Post Hoc Test Group Means (distance walked) Post-test Midpoint Pretest Mean Diff 0.91 1.07 -0.16 0.91 0.72 0.19 1.07 0.72 0.35* *p < .05; T(.05) = .22 Table 23. Group C’s mean and standard deviation of distance (miles) walked from pretest, midpoint, to post-test. Pre MP Post M 0.72 1.07 0.91 SD 0.53 0.58 0.56

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39 Table 24. Summary ANOVA for differences in pretest, midpoint, and post-test duration (minutes) markers in the APF wa lking exercise therapy for PAD. Group C Source SS df MS F Treat 1002 2 501 6.9* Within 10609 75 141 Between Subjects 697625279 Error 36325072.66 Total 11611 77 *p < .05; F(.05) = 3.18 Table 25. Ordered mean differences on the effects of the APF walking exercise therapy for PAD on group C duration (minutes) performance using a Tukey Post Hoc Test Group Means (minutes walked) Post-test Midpoint Pretest Mean Diff 27.92 31.56 -3.64 27.92 22.82 5.1 31.56 22.82 8.74* *p < .05; T(.05) = 5.72

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40 Table 26. Group C’s mean and standard deviation of duration walked from pretest, midpoint, to post-test. Pre MP Post M 22.82 31.56 27.92 SD 10.07 11.44 13.87 Table 27. Summary ANOVA for differences in pretest, midpoint, and post-test rate (mi/hr) markers in the APF walki ng exercise therapy for PAD. Group C Source SS df MS F Treat 0.22 2 0.11 0.62 Within 36.83 75 0.49 Between Subjects 28251.13 Error 8.67500.17 Total 37.05 77 p > .05; F(.05) = 3.18 Table 28. Group C’s mean and standard deviation of rate (mi/hr) walked from pretest, midpoint, to post-test. Pre MP Post M 1.8 1.92 1.89 SD 0.75 0.72 0.62

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41 CHAPTER 4 DISCUSSION The alternative hypothesis of this stud y was that the accommodating pain-free (APF) walking exercise therapy for periphera l arterial disease (PAD) would have an effect on exercise performance in patients with intermittent claudication (IC) due to PAD. The results indicate that the walking program did indeed have an effect on exercise performance. Group A The participants increased the am ount of distance, duration, and rate walked from pretest to post-test by 80% (p < .001), 27% (p < .001), and 37% (p < .001) respectively. The Tukey Post Hoc Test f ound a significant difference between the posttest and pretest and between the midpoint and pr etest. A goal of this therapy program is to increase the participants’ di stance, duration, and rate from their first session to their last session, so it is expected that the findings are significant from pretest to post-test. Also, significance was found between the pretest and midpoint which implies that for this group of participants their exercise pe rformance is improving significantly by the midpoint of their therapy. The program length for this group of participants was 2 to 9 weeks. Therefore, a program that has a similar time span could f eel confident that the length is optimal and positive results can be ascertained as s oon as the midpoint of the program.

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42 Group B The participants increased the am ount of distance, duration, and rate walked from pretest to post-test by 122% (p < .001), 56% (p < .001), and 43% (p < .001) respectively. The Tukey Post Hoc Test found a significant difference between the pretest and post-test and pretest and midpoint va riables of both the distance and duration variables. These findings i ndicate that once again the goal of increasing exercise performance from pretest to post-test was in fact met as well as increasing exercise performance from pretest to midpoint was met in accordance with Group A. The Tukey Post Hoc Test further revealed that rate was significant fr om post-test to midpoint, posttest to pretest, and midpoint to pretest. It appears that a program length of 10-14 weeks is the most efficient length to produce significant rate result s throughout the duration of the program. Group B’s rate results are very positive. R ecall that the population in this study is defined as elderly and one of their limitations other than walking with pain is that they walk to slow. Many of the patients reported to the P.I. under informal conditions that they would like to be able to walk with their grandchildren rather than feel as if they are hol ding the children back. Therefore, a person attending the program fr om 10-14 weeks could expect to increase their rate through the dura tion of the program. Group C The participants increased the am ount of distance, duration, and rate walked from pretest to post-test by 26% (p = .002), 22% (p = .002), and 5% (p = .541) respectively. The Tukey Post Hoc Test found a significant difference between the midpoint and pretest data of both the distance and duration variables. The rate for this group was not found to be significant at all. This group participated in the program from

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43 15-94 weeks. The data for this group can be misleading and can be misinterpreted. The reason for such a lack of improvement percen tage and/or a lack of significance of the findings is simply due to the particip ants’ maintenance of the program. Once the participants have become accustomed to the program and have trained their minds and bodies to walk without pain they stop improving and start maintaining their new level of exercise. Le isure athletes maintain their exercise levels, they generally find a point that they can maintain week afte r week and stay there unless they are training for a race. So essentially group C represents the maintenance stage of the program. The participants may not be walking as fast as they were during their midpoint but they are still walking without pain and maintaini ng all of their improvements in exercise performance. Furthermore, if the participants were to continue to increase their rate, they would probably be jogging instead of walking. Groups A, B, and C “The three goals of the APF exer cise therapy are as follows: To have the participants walk farther, longer, and fast er without pain to improve their functional ability and social interaction” (Martinez et al., 2006, p. 46). Groups A, B, and C increased thei r distance walked by 80% (p < .001), 122% (p < .001), and 26% (p = .002) respectively. Figur e 1 contains the distance totals for each group from pretest to midpoint to post-test. The groups increased their duration walked by 27% (p < .001), 56% (p < .001), and 22% (p = .002) respectively. Figure 2 contains the duration totals for each group from pretest to midpoint to post-test. Finally, the groups increased their rate walked by 37% (p < .001), 43% (p < .001), and 5% (p = .541). Figure 3 contains the rate totals for each gr oup from pretest to midpoi nt to post-test.

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44 Clearly, in order to produce the most improvement in exercise performance the optimal program length is 10-14 weeks (Group B). To produce the second best improvement in exercise performance the opt imal program length is 2-9 weeks (Group A). Once the participants have reached 15 weeks and beyond they should be considered in a maintenance stage and analyzed accordingly. 0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2 A B C Total distance walked from pretest to midpoint to post-testMiles Pre MP Post Figure 1. Effects of the APF walking exerci se therapy for PAD on the amount of distance (miles) walked from pretes t to midpoint to post-test. Group A represents program participation fr om 2-9 weeks. Group B represents participation from 10-14 weeks. Group C represents program participation from 15-94 weeks. = p < .05. * * * *

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45 0 5 10 15 20 25 30 35 40 45 50 ABC Total duration walked from pretest to midpoint to posttestMinutes Pre MP Post Figure 2. Effects of the APF walking exercise therapy for PAD on the amount of duration (minutes) walked from pretes t to midpoint to post-test. Group A represents program participation fr om 2-9 weeks. Group B represents participation from 10-14 weeks. Group C represents program participation from 15-94 weeks. = p < .05. 0 0.5 1 1.5 2 2.5 3 ABC Total walking rate from pretest to midpoint to post-testMiles/hour Pre MP Post Figure 3. Effects of the APF walking exercise th erapy for PAD on the amount of velocity (mi/hr) walked from pretest to midpoint to post-test. Group A represents program participation from 2-9 weeks. Group B represents participation from 10-14 weeks. Group C represents program participation from 15-94 weeks. = p < .05. * * * * * * *

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46 Every group accomplished the first goal of the program which was to walk a farther distance then they had been walking before the start of the program. The patient population has difficulty walking around the gr ocery store without ha ving to stop because of leg pain. So if this program can at leas t allow the individual to walk through the store without pain then the person has indeed increased their qua lity of life. Further, the groups all accomplished the second and third goals of the program which is to walk longer and fa ster. Therefore, the program participants can not only walk through the grocery store without pain, they ca n also walk faster and longer to keep up with their grandchildren. Martinez et al. (2006) reviewed three studies th at used the APF protocol: Study one (Pena, Stopka, and Todorovich, 2003) had 13 participants (n = 13) with an average age of 71 years. The participants met for six weeks, twice a week and had an average of 10 visits. Study two (Barak, Stopka, Todorovich, and Siders, 2004) had 12 participants (n = 12). The participants met for six weeks, twic e a week. Study three (Martinez and Stopka, 2005) had 10 participants (n = 10) with an average age of 73 years. The participants met for 8 weeks, twice a week. (p. 45) The distance improvements were 148%, 105%, and 116% for studies 1, 2, & 3 respectively (p .05). The duration improvements were 94%, 56%, and 50% for studies 1, 2, & 3 respectively (p .05). The rate improvement s were 34%, 41%, and 32% for studies 1, 2, & 3 respectively (p .05). The improvements found from Martinez et al. are consistent with the findings from this study. Stopka et al. (1998) us ed the APF exercise therapy and found an improvement of 408.5% (p < .01) in distance, an improvement of 163.3% (p < .01) in duration, and an improvement of 94.4% in ra te (p < .01). The participants (n = 46) attended therapy twice a week for 9 weeks. The findings in the Stopka et al. study are

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47 clearly much higher than the findings from th e present study. However, both studies had significant improvements in all the exercise performance factors and serve as further demonstration of the quality of the APF program for improving ex ercise performance. Gardner and Poehlman (1995) determ ined through their meta-analysis that the optimal program for treating IC due to PAD is three sessions per week for six months walking at near-maximal pain. The results of their meta-analysis f ound that the distance would improve by 122% (p < .001) if using th eir suggested program. All of the APF studies cited in this discussi on have either been close to, been exactly the same (Group B of this study), or have usur ped the expected 122% improvement of the near-maximal pain training as advocated by Gardner and Poehlm an (1995). Clearly the findings from the APF protocol are consistent, or much stronger, with the fi ndings from the Gardner and Poehlman (1995 protocol considering the APF protocol was done twice a week versus 3 times a week; the APF protocol was 10-14 weeks versus 6 months. The main difference is that the Gardner and Poehlman (1995) prot ocol elicits near-maximal pain while the APF protocol advocates pain-free walking at all times. A new trend in the literature is taking place now. Studies are starting to look at the effects of low-intensity and high-intensi ty therapy (as noted in the introduction). Gardner et al. (2005) looked at the di stance improvements of both a low and high intensity program. They found that after a 6 month program of 3 times a week that absolute distance improved by 61% (p < .01) in the low-intensity group and by 63% (p < .01) in the high-intensity gr oup and initial distance improved by 109% (p < .01) in both the low and high-intensity groups. The results of the APF studies used and cited in this

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48 study are once again either slight ly lower or greatly higher than the results of the Gardner et al. study. Limitations First, repeated measures ANOVA wa s used based on a number of assumptions. One of the assumptions stated in the data analysis subsection of the methods and materials section was that the means were acquired with random selection. This assumption is false. The participants were chosen for the program based on their current diagnosis of IC and were not randomly select ed. Further, the means were not acquired randomly; they were specifically chosen to satisfy the parameters of the research question. For example, the means for the pret est were chosen base d on the participants’ first and second session. Second, many experimental research ers believe that studies done without a control group is invalid because control groups allow the researcher to compare. The study here did not use a control group. Literature reviews have shown that exercise for this population is imperative. This study would find it ethically wrong to exclude patients from the program because they are controls. Those very controls could experience further morbidity and/or mortality s imply for serving as controls in our study. Therefore, this study understa nds the importance of includi ng everyone. Furthermore, the research design used in this study is a valid, reliabl e, and established design and should not be given less respect becaus e of the lack of a comparison group. Third, the P.I. did not take all of the original data from each participant. The data were taken from over 20 years of program participants. However, the basic method for compiling the data over the years was essentially the same (and supervised by the same researcher). Therefore, the P.I. wa s able to successfully access and analyze the

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49 needed data. Further, the vol unteers involved with the progr am changed frequently over the years and that could have made an imp act on the success of the participants. Fourth, all of the pa rticipants volunteered to be a member of the program. Therefore, the participants may have alrea dy had a positive inclinat ion towards exercise.

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50 CHAPTER 5 CONCLUSION AND FUTURE DIRECTIONS Conclusion The above discussion clearly indi cates that the accommodating pain-free (APF) protocol is at the very least comparable if not better than the n ear-maximal and low and high-intensity programs. The most important fact to remember when choosing between the different protocols is to determine whether or not the participants will want to feel pain while exercising. It has been eviden ced by the P.I. in this study that elderly individuals prefer not to feel pain while ex ercising and will stay with the program longer when they enjoy themselves, as evidenced by the 26 participants in Group C who were involved with the program in this study for 15-94 weeks. Finally, to achieve the best results in distance, duration, and rate impr ovements, a program of 10-14 weeks is the optimal length and this has great relevance for third party reimburse ment policies due to the briefer frequency and duration of sessions needed for improvement. It is hypothesized the improvements demonstrated in exercise performance will hopefully reduce the cardiovascular morbidity and mort ality of all the participants based on a review of the li terature. Future Directions It is important to note that the pathophysiology st ated in the introduction is based on near-maximal pain exercise thera py. Boyd et al., 1984 used the APF protocol and found that after 12 weeks, three times a week with eight part icipants that their distance increased by 138% and their durati on increased 103%. Boyd et al., 1984 further

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51 found significant increases in pulse volume am plitude in the left calf and ankle. The author suggested that furthe r research be done to “examin e the possibility of a large vessel response to low level training in tensities” pg. 120. The study also found significant mean pre to post-training muscle blood flow increases. To date, Boyd et al., 1984 is th e only study found that has looked at the pathophysiology of the APF protocol. There is a clear need to do more studies that directly focus on the various pathophysiologi es mentioned in the introduction as related to the APF protocol. Until then, APF rese archers can only speculate the reasons for exercise performance while comparing to th e established literature pathophysiology.

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52 APPENDIX A GOALS AND RATIONALE

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53 APPENDIX B CLAUDICATION QUESTIONNAIRE [

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54 APPENDIX C MEDICAL HISTORY QUESTIONNAIRE

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55

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56 APPENDIX D DEMOGRAPHIC INFORMATION

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57 APPENDIX E INFORMED CONSENT

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58 APPENDIX F THERAPEUTIC STRETCHES

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59

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60 APPENDIX G EXERCISE TRAINING LOG

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61 LIST OF REFERENCES Askew, C.D., Green, S., Walker, P.J., Kerr, G.K., Green, A.A., Williams, A.D., & Febbraio, M.A. (2005). Skeletal muscle phe notype is associat ed with exercise tolerance in patients with peripheral arterial disease. Journal of Vascular Surgery, 41(5), 802-807. Barak, S. (2004). Benefits of low-intensity pain-free exercise for participants with peripheral vascular disease. Unpublished ma ster’s thesis, University of Florida, Gainesville, FL. Barak, S., Stopka, C., Todorovich, J., & Siders R. (2004). Benefits of low-intensity pain-free treadmill exercise on functional capacity of individuals presenting with intermittent claudication due to peripheral va scular disease. Poster presentation for the AAALF/AALR for the 2005 AAHPERD National Convention, Chicago, Illinois, April 2005. Boyd, C., Bird, P., Teates, C., Wellons, H., MacDougall, MA., & Wolfe, L. (1984). Pain free physical training in intermitten t claudication. The Journal of Sports Medicine and Physical Fitness, 24(2), 112-122. Carlon, R., Morlino, T., & Maiolino, P. (2003). Beneficial effects of exercise beyond the pain threshold in intermittent claudicati on. Italian Heart Journal,. 4(2), 113-20. Centers for Disease Control. (2005a) What is Epi Info?. Retrieved May 25, 2006, from: http://www.cdc.gov/epiinfo/ Centers for Disease Control. (2005b). Hospita lizations for lower extremity conditions. Retrieved November 29, 2005, from: http://www.cdc.gov/diabetes /statistics/hosplea/fig1.htm Cheetham, D.R., Burgess, L., Elllis, M., W illiams, A., Greenhalgh, R.M., & Davies, A.H. (2004). Does supervised exercise offer ad juvant benefit over ex ercise advice alone for the treatment of intermittent claudi cation? A randomized trial. European Journal of Vascular and E ndovascular Surgery, 27, 17-23. Chong, P.F., Golledge, J., Greenhalgh, R.M., & Da vies, A.H. (2000). Exercise therapy or angioplasty? A summation analysis. European Journal of Vascular and Endovascular Surgery, 20, 4-12. Criqui, M.H. (2001). Peripheral arterial dis ease—epidemiological aspects. Vascular Medicine, Suppl., 3-7.

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62 Ekroth, R., Dahllof, A.G., Gundevall, B., Ho lm, J., & Schersten, T. (1978). Physical training of patients with intermittent claudi cation: indications, methods, and results. Surgery, 84, 640-643. Foley, W.T. (1957). Treatment of gangrene of the feet and legs by wa lking. Circulation, 15, 689-700. Fuster, V., Moreno, P.R., Fayad, Z.A., Corti, R., & Badimon, J.J. (2005a). Atherothrombosis and high-risk plaque. Part 1: Evolving concepts. Journal of American College of Cardiology, 46(6), 937-54. Fuster, V., Moreno, P.R., Fayad, Z.A., Corti, R., & Badimon, J.J. (2005b). Atherothrombosis and high-risk plaque Part 2: Appro aches by noninvasive computed tomographic/magnetic resonance imaging. Journal of American College of Cardiology, 46(7), 1209-18. Gardner, A.W., Montgomery, P.S., Flinn, W.R. & Katzel, L.I. (2005). The effect of exercise intensity on the response to ex ercise rehabilitati on in patients with intermittent claudication. Journa l of Vascular Surgery, 42(4), 702-709. Gardner, A., & Poehlman, EJ. (1995). Exerci se rehabilitation programs for the treatment of claudication pain: a meta-analysis. Journal of the American Medical Association, 274(12), 975-980. Hiatt, W.R. (2004). Carnitine and periphera l arterial disease. Annals New York Academy of Sciences, 1033, 92-98. Hiatt, W., Regensteiner, J., Hargarten, M., Wo lfel, E., & Brass, E. (1990). Benefit of exercise conditioning for patients with peri pheral arterial disease. Circulation, 81, 602-9. Hiatt, W., Wolfel, E., Meier, R., & Regenste iner, J. (1994). Superiority of treadmill walking exercise vs. strength training for pa tients with peripheral arterial disease. Circulation, 90, 1866-1874. Izquierdo-Porrera, A.M., Gardner, A.W., Powell, C.C., & Katzel, L.I. (2000). Effects of exercise rehabilitation on cardiovascula r risk factors in older patients with peripheral arterial occlusiv e disease. Journal of Va scular Surgery, 31(4), 670-677. Kakkos, S.K., Geroulakos, G., & Nicolaides, A.N. (2005). Improvement of the walking ability in intermittent claudication due to superficial femoral artery occlusion with supervised exercise and pneumatic f oot and calf compression: A randomized controlled trial. European Journal of Vascular and Endovascular Surgery, 30, 164175. Killewich, L.A., Macko, R.F., Montgomery, P. S., Wiley, L.A., & Gardner, A.W. (2004). Exercise training enhances endogenous fibri nolysis in peripheral arterial disease. Journal of Vascular Surgery, 40(4), 741-745.

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63 Krankenberg, H., Sorge, I., Zeller, T., & Tubl er, T. (2005). Percut aneous transluminal angioplasty of infrapopliteal arteries in patients with intermittent claudication. Catheterization and Cardiovasc ular Interventions, 64, 12-17. Larsen, D.A., & Lassen, N.A. (1966). Effects of daily muscular exercise in patients with intermittent claudication. Lancet, 2, 1093-1096. Lundgren, F., Dahllof, A., Schersten, T., & Bylund-Fellensiu, A. (1989). Muscle enzyme adaptation in patients with peripheral arte rial insufficiency: spontaneous adaptation, effect of different treatments, and conse quences on walking performance. Clinical Science, 77, 485-493. Mahler, D.A., Froelicher, V.F., Miller, N.H., & York, T.D. (1995). ACSM’s guidelines for exercise testing and prescription (5th e d.). Baltimore: Williams & Wilkins. Mannarino, E., Pasqualino, L., Menna, M., Mara goni, G., & Orlandi, U. (1989). Effects of physical training on peripheral vascular disease: a controlled study. Angiology, 40(1), 5-10. Marburger, K.L. (1992). Effects of lowintensity, pain-free exercise on muscle metabolism in patients with peripheral vascular disease evaluated by 31PNMR spectroscopy. Unpublished master’s thesis, University of Florida, Gainesville, FL. Martinez, C.A., Frazer, C., Stopka, C.B., Mar tinez, O., Lewis, J., & Todorovich, J. (2005). Back on their feet: study finds exer cise improvements in patients with peripheral arterial disease. ADVANCE for P hysical Therapists and PT Assistants, 16(8), 31-32, 57. Martinez, C., & Stopka, C. (2005). Low-inte nsity exercise therapy for women with peripheral arterial disease...i s it beneficial, and can it be performed in community based clinics and fitness cen ters? Poster pres entation for the 3rd Annual Women’s Health Research Day at the University of Florida. Martinez, C., Stopka, C., & Stradley, J. ( 2006). Back on their f eet, again. ADVANCE for Physical Therapists and PT Assistants, 17(8), 44-47. Ng, P.W.K., Hollingsworth, S.J., Luery, H., Ku mana, T.J., & Chaloner, E.J. (2005). Intermittent claudication: exercise-increas ed walking distance is not related to improved cardiopulmonary fitness. European Journal of Vascular and Endovascular Surgery, 30, 391-394. Ouriel, K. (2001). Peripheral arte rial disease. Lancet, 358, 1275-1264. Pasupathy, S., Naseem, K.M., & Homer-Vannias inkam, S. (2005). Effects of warm-up on exercise capacity, platelet activation and platelet-l eucocyte aggregation in patients with claudication. British Journal of Surgery, 92, 50-55.

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64 Pena, K., Stopka, C., & Todorovich, J. (2003). Effects of low-intensity exercise on participants with peripheral vascular arteri al disease. Poster presentation for the Graduate Student Council Forum at the University of Florida. Remijnse-Tamerius, H.C., Duprez, D., De Buyzere, M., Oeseburg, B., Clement, D.L. (1999). Why is training effective in the treatment of patients with intermittent claudication? Int. Angiol, 18, 103-112. Santilli, JD., Rodnick, JE., & Santilli, SM. (1996 ). Claudication: diagnosis and treatment. American Family Physician, 53(4), 1245-53. Skinner, J.S., & Strandness, D.E. (1967). Exerci se and intermittent claudication: effect of physical training. Circulation, 36, 23-29. Slordahl, S.A., Wang, E., Hoff, J., Kemi, O.J ., Amundsen, B.H., & Helgerun, J. (2004). Effective training for patients with in termittent claudication. Scandinavian Cardiovascular Journal, 39, 244-249. Spronk, S., Dolman, W., Beolhouwer, R.U., Veen, HF., & den Hoed, PT. (2003). The vascular nurse in practice: results of pres cribed exercise training in patients with intermittent claudication. Journa l of Vascular Nursing, 21(4), 141-4. Stewart, K., Hiatt, W., Regensteiner, J., & Hirsch, A. (2002). Exercise training for claudication. New England Jour nal of Medicine, 327(24), 1941-1951. Stopka, C., Wolper, R., Scott, K., Seeger, J., Ballinger, R., & Graves, J. (1998). Pain-free training for people with peripheral vascul ar disease? Palaestra, 14(2), 20-23. Tan, K.H., De Cossart, L., & Edwards, P. R. (2000). Exercise training and peripheral vascular disease. British Journal of Surgery, 87, 553-562. Tisi, P.V., & Shearman, C.P. (1998). The evid ence for exercise-induced inflammation in intermittent claudication: should we encour age patients to stop walking? European Journal of Vascular Endovascular Surgery, 15, 7-17. Treat-Jacobson, D., & Walsh, ME. (2003). Trea ting patients with peripheral arterial disease and claudication. Journa l of Vascular Nu rsing, 21(1), 5-14. Turton, E.P., Spark, J.I., Mercer, K.G. et al. (1998). Exercise-induced neutrophil activation in claudicants: a physiological or pathological response to exhaustive exercise? European Journal of Vascular and Endovascular Surgery, 16, 192-196.

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65 BIOGRAPHICAL SKETCH Ms. Coleen Archer, born and raised in We st Virginia, is currently completing the requirements for a Master of Science degr ee in the College of Health and Human Performance at the University of Florida. Ms. Archer specialized in adapted physical activity. Ms. Archer received her bachelor’s de gree in exercise and sport sciences from the College of Health and Human Performance at the University of Florida in May 2003. She specialized in exercise physiology. Ms. Archer is a Master Teacher of Adapted Aquatics (MTAA) and a Certified Strength and Conditioning Special ist (CSCS). She plans to continue her education to pursue a career in adapted physical activity.


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Permanent Link: http://ufdc.ufl.edu/UFE0015221/00001

Material Information

Title: Accommodating pain-free exercise therapy for peripheral arterial disease
Physical Description: Mixed Material
Language: English
Creator: Archer, Colleen E. ( Dissertant )
Stopka-Boyd, Christine E. ( Thesis advisor )
Publisher: University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: 2006
Copyright Date: 2006

Subjects

Subjects / Keywords: Health Education and Behavior thesis, M.S
Dissertations, Academic -- UF -- Health Education and Behavior

Notes

Abstract: The purpose of this study was to determine the effects of the accommodating pain-free (APF) walking exercise therapy program on exercise performance in patients with intermittent claudication (IC) due to peripheral arterial disease (PAD). The procedures of the study consisted of examining the improvements in walking performance before, during and after the implementation of the APF walking exercise therapy program. Group A (n = 28) participated in the program for two to nine weeks, group B (n = 30) participated in the program for 10-14 weeks, and group C (n = 26) participated in the program for 15-94 weeks. An average of the dependent variables from pretest to midpoint to post-test was calculated. The research design used was a pretest post-test randomized group design for three testing sessions. The dependent variable was exercise performance. The independent variable was the APF walking exercise therapy. Measurements taken include walking distance, walking duration, and walking rate. The protocol included the following: blood pressure and heart rate measurements taken before and after walking, hold-relax proprioceptive neuromuscular facilitation stretching before and after walking, walking continually on a treadmill for 30 to 50 minutes below the participant?s individualized walking pain threshold, and a recording on the participant?s training log of total time and total distance walked. The statistical program SPSS 12.0 was used to analyze the data and examine changes in the pretest, midpoint, and post-test walking performance variables using a repeated measures design (ANOVA) with an alpha level of .05 to determine statistical significance. If there was a significant F-value, the Tukey Post Hoc Test (TPHT) was used to determine further significance between the groups. All data are presented as mean, standard deviation and percent improvement. The participants in Group A increased the amount of distance, duration, and rate walked from pretest to post-test by 80% (p < .001), 27% (p < .001), and 37% (p < .001) respectively. The TPHT found a significant difference between the post-test and pretest and between the midpoint and pretest. The participants in Group B increased the amount of distance, duration, and rate walked from pretest to post-test by 122% (p < .001), 56% (p < .001), and 43% (p < .001) respectively. The TPHT found a significant difference between the pretest and post-test and pretest and midpoint variables of both the distance and duration variables. The TPHT further revealed that rate was significant from post-test to midpoint, post-test to pretest, and midpoint to pretest. The participants in Group C increased the amount of distance, duration, and rate walked from pretest to post-test by 26% (p = .002), 22% (p = .002), and 5% (p = .541) respectively. The TPHT found a significant difference between the midpoint and pretest data of both the distance and duration variables. To achieve the best results in distance, duration, and rate improvements, a program of 10-14 weeks is the optimal length.
Subject: accommodating, arterial, disease, exercise, free, heart, pain, peripheral, therapy, walking
General Note: Title from title page of source document.
General Note: Document formatted into pages; contains 75 pages.
General Note: Includes vita.
Thesis: Thesis (M.S.)--University of Florida, 2006.
Bibliography: Includes bibliographical references.
General Note: Text (Electronic thesis) in PDF format.

Record Information

Source Institution: University of Florida
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution and holding location.
System ID: UFE0015221:00001

Permanent Link: http://ufdc.ufl.edu/UFE0015221/00001

Material Information

Title: Accommodating pain-free exercise therapy for peripheral arterial disease
Physical Description: Mixed Material
Language: English
Creator: Archer, Colleen E. ( Dissertant )
Stopka-Boyd, Christine E. ( Thesis advisor )
Publisher: University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: 2006
Copyright Date: 2006

Subjects

Subjects / Keywords: Health Education and Behavior thesis, M.S
Dissertations, Academic -- UF -- Health Education and Behavior

Notes

Abstract: The purpose of this study was to determine the effects of the accommodating pain-free (APF) walking exercise therapy program on exercise performance in patients with intermittent claudication (IC) due to peripheral arterial disease (PAD). The procedures of the study consisted of examining the improvements in walking performance before, during and after the implementation of the APF walking exercise therapy program. Group A (n = 28) participated in the program for two to nine weeks, group B (n = 30) participated in the program for 10-14 weeks, and group C (n = 26) participated in the program for 15-94 weeks. An average of the dependent variables from pretest to midpoint to post-test was calculated. The research design used was a pretest post-test randomized group design for three testing sessions. The dependent variable was exercise performance. The independent variable was the APF walking exercise therapy. Measurements taken include walking distance, walking duration, and walking rate. The protocol included the following: blood pressure and heart rate measurements taken before and after walking, hold-relax proprioceptive neuromuscular facilitation stretching before and after walking, walking continually on a treadmill for 30 to 50 minutes below the participant?s individualized walking pain threshold, and a recording on the participant?s training log of total time and total distance walked. The statistical program SPSS 12.0 was used to analyze the data and examine changes in the pretest, midpoint, and post-test walking performance variables using a repeated measures design (ANOVA) with an alpha level of .05 to determine statistical significance. If there was a significant F-value, the Tukey Post Hoc Test (TPHT) was used to determine further significance between the groups. All data are presented as mean, standard deviation and percent improvement. The participants in Group A increased the amount of distance, duration, and rate walked from pretest to post-test by 80% (p < .001), 27% (p < .001), and 37% (p < .001) respectively. The TPHT found a significant difference between the post-test and pretest and between the midpoint and pretest. The participants in Group B increased the amount of distance, duration, and rate walked from pretest to post-test by 122% (p < .001), 56% (p < .001), and 43% (p < .001) respectively. The TPHT found a significant difference between the pretest and post-test and pretest and midpoint variables of both the distance and duration variables. The TPHT further revealed that rate was significant from post-test to midpoint, post-test to pretest, and midpoint to pretest. The participants in Group C increased the amount of distance, duration, and rate walked from pretest to post-test by 26% (p = .002), 22% (p = .002), and 5% (p = .541) respectively. The TPHT found a significant difference between the midpoint and pretest data of both the distance and duration variables. To achieve the best results in distance, duration, and rate improvements, a program of 10-14 weeks is the optimal length.
Subject: accommodating, arterial, disease, exercise, free, heart, pain, peripheral, therapy, walking
General Note: Title from title page of source document.
General Note: Document formatted into pages; contains 75 pages.
General Note: Includes vita.
Thesis: Thesis (M.S.)--University of Florida, 2006.
Bibliography: Includes bibliographical references.
General Note: Text (Electronic thesis) in PDF format.

Record Information

Source Institution: University of Florida
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution and holding location.
System ID: UFE0015221:00001


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ACCOMMODATING PAIN-FREE EXERCISE THERAPY FOR PERIPHERAL
ARTERIAL DISEASE















By

COLEEN ARCHER


A THESIS PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
MASTER OF SCIENCE

UNIVERSITY OF FLORIDA


2006

































Copyright 2006

by

Coleen Archer















ACKNOWLEDGMENTS

I would like to thank my husband, Oscar Martinez, for all of his support throughout

my research experience as well as through my graduate career. I of course would not

even be here today if it was not for my wonderful mother, Debra Kilgore, my wonderful

father, Bill Archer, my wonderful stepfather, Pat Stinson, and my wonderful stepmother,

Evonda Archer. I thank them tremendously. Finally, I would like to thank Dr. Christine

Stopka and her family. Dr. Stopka has served as my professor and advisor. I could not

have completed this thesis without her guidance and support.
















TABLE OF CONTENTS



A C K N O W L E D G M E N T S ......... ................................................................................... iii

LIST OF TABLES ............ ......................................... .............. vi

LIST OF FIGU RE S ........ ........ .................................. ......... .............. viii

ABSTRACT .............. .......................................... ix

CHAPTER

1 IN TR O D U C T IO N ............................................................. .. ......... ...... .....

D definition of Term s ........................... ........ .......... ................. 1
Literature Review ................................... .. .......... ..................
E x ercise ............................................... 4
N ear-M axim al Pain .................................. .. .. ................ ................ ........ 5
Accommodating Pain-Free (APF) Walking Exercise Therapy ..................................6
Accommodating High and Low Intensity Training................... .....................................7
P athophy siology ............................................... .......................... 7
P purpose ............................................................. . 9

2 M ATERIALS AND M ETHOD S ........................................... .......................... 10

P rin cip al Inv estig ator......... .............................................................. ...... .... ... .. 10
P articip ants an d S getting ....................................................................... ..................10
P participants ............................................................... .. ... ......... 10
In strum ents ...................................................................................................11
E x erc ise S ettin g s ............................................................................................ 12
P ro c e d u re s .................. ........................................................................................... 1 2
T reatm ent P rotocol ...................... ........ .............. .................... ........13
M e a su re s ......................................................................................................... 1 4
R research D design ....................................................... 15
V ariab le s ....................... .......................... .............. 15
The EP Dependent Variables (Exercise Performance) ............................... 15
Independent V ariable.............................................. ............... 15
D ata Analysis .................. ........................................... 16

3 RE SU LTS ........................................................................................................... 18










G ro u p A ........................................................................ 1 8
T otal D istan ce W alk ed ............................................. ...................................... 18
T otal D uration W alked ................................................................................... 19
Total Walking Rate...................... ................ ................ 20
G ro u p B ............................................................................2 1
T otal D istan ce W alk ed ............................................................... ....................2 1
Total D uration W alked .............................................. ..... ........................ 23
Total Walking Rate...................... ................ ................ 24
G ro u p C ............................................................................2 5
T otal D istan ce W alk ed ............................................................... ....................2 5
Total D uration W alked .............................................. ..... ........................ 26
Total Walking Rate...................... ................ ................ 27

4 D ISC U S SIO N ............................................................................... 4 1

G ro u p A ..................................................................4 1
G ro u p B ..............................................................................4 2
G ro u p C .............................................................4 2
G ro u p s A B an d C ................................................................................................ 4 3
L im itatio n s .......................................................................................4 8

5 CONCLUSION AND FUTURE DIRECTIONS.............................. .... ...........50

C o n c lu sio n ............................................................................................................. 5 0
F utu re D direction s ................................................................50

APPENDIX

A GOALS AND RATIONALE .................................................52

B CLAUDICATION QUESTIONNAIRE .........................................53

C MEDICAL HISTORY QUESTIONNAIRE........................ .... .......... 54

D DEMOGRAPHIC INFORMATION .....................................................................56

E INFORMED CONSENT ................ ........ ....... .........57

F THERAPEUTIC STRETCHES .............................................. 58

G EXERCISE TRAINING LOG ....................................................................60

L IST O F R EFER EN CE S ..................................... .................................................................61

B IO G R A PH IC A L SK E T C H ........................................................................................ 65






v
















LIST OF TABLES


Table page

1. G general characteristics of the study...................................................................... 11

2. Intermittent claudication (IC) pain scale ...... ......... ....................................... 17

3. Summary ANOVA for differences in pretest, midpoint, and post-test .................28

4. Ordered mean differences on the effects of the APF exercise .............................29

5. Group A's mean and standard deviation of distance (miles) .............................29

6. Summary ANOVA for differences in pretest, midpoint, and post-test .................30

7. Ordered mean differences on the effects of the APF walking .............................30

8. Group A's mean and standard deviation of duration (minutes) walked..................31

9. Summary ANOVA for differences in pretest, midpoint, and post-test .................31

10. Ordered mean differences on the effects of the APF walking .............................32

11. Group A's mean and standard deviation of rate (mi/hr) .............. ...................32

12. Summary ANOVA for differences in pretest, midpoint, post-test........................33

13. Ordered mean differences on the effects APF walking .....................................33

14. Group B's mean and standard deviation of distance (miles)................................34

15. Summary ANOVA for differences in pretest, midpoint, and post-test .................34

16. Ordered mean differences on the effects of the APF ................... ..... ...........35

17. Group B's mean and standard deviation of duration (minutes) ...........................35

18. Summary ANOVA for differences in pretest, midpoint, and post-test .................36

19. Ordered mean differences on the effects of the APF ................... ..... ...........36

20. Group B's mean and standard deviation of rate (mi/hr) walked from ....................37









21. Summary ANOVA for differences in pretest, midpoint, and post-test .................37

22. Ordered mean differences on the effects of the APF .............................................38

23. Group C's mean and standard deviation of distance (miles)................................38

24. Summary ANOVA for differences in pretest, midpoint, and post-test .................39

25. Ordered mean differences on the effects of the APF walking .............................39

26. Group C's mean and standard deviation of duration walked..............................40

27. Summary ANOVA for differences in pretest, midpoint, and post-test .................40

28. Group C's mean and standard deviation of rate (mi/hr) walked.............................40
















LIST OF FIGURES


Figure p

1. Effects of the APF walking exercise therapy for PAD on the.............................44

2. Effects of the APF walking exercise therapy for PAD on the amount....................45

3. Effects of the APF walking exercise therapy for PAD on the amount....................45















Abstract of Thesis Presented to the Graduate School
of the University of Florida in Partial Fulfillment of the
Requirements for the Degree of Master of Science

ACCOMMODATING PAIN-FREE EXERCISE THERAPY FOR PERIPHERAL
ARTERIAL DISEASE

By

Coleen Archer

August 2006

Chair: Christine E. Stopka-Boyd
Major Department: Health Education and Behavior

The purpose of this study was to determine the effects of the accommodating pain-

free (APF) walking exercise therapy program on exercise performance in patients with

intermittent claudication (IC) due to peripheral arterial disease (PAD). The procedures of

the study consisted of examining the improvements in walking performance before,

during and after the implementation of the APF walking exercise therapy program.

Group A (n = 28) participated in the program for two to nine weeks, group B (n = 30)

participated in the program for 10-14 weeks, and group C (n = 26) participated in the

program for 15-94 weeks. An average of the dependent variables from pretest to

midpoint to post-test was calculated. The research design used was a pretest post-test

randomized group design for three testing sessions. The dependent variable was exercise

performance. The independent variable was the APF walking exercise therapy.

Measurements taken include walking distance, walking duration, and walking rate. The

protocol included the following: blood pressure and heart rate measurements taken before









and after walking, hold-relax proprioceptive neuromuscular facilitation stretching before

and after walking, walking continually on a treadmill for 30 to 50 minutes below the

participant's individualized walking pain threshold, and a recording on the participant's

training log of total time and total distance walked. The statistical program SPSS 12.0

was used to analyze the data and examine changes in the pretest, midpoint, and post-test

walking performance variables using a repeated measures design (ANOVA) with an

alpha level of .05 to determine statistical significance. If there was a significant F-value,

the Tukey Post Hoc Test (TPHT) was used to determine further significance between the

groups. All data are presented as mean, standard deviation and percent improvement.

The participants in Group A increased the amount of distance, duration, and rate walked

from pretest to post-test by 80% (p < .001), 27% (p < .001), and 37% (p < .001)

respectively. The TPHT found a significant difference between the post-test and pretest

and between the midpoint and pretest. The participants in Group B increased the amount

of distance, duration, and rate walked from pretest to post-test by 122% (p < .001), 56%

(p < .001), and 43% (p < .001) respectively. The TPHT found a significant difference

between the pretest and post-test and pretest and midpoint variables of both the distance

and duration variables. The TPHT further revealed that rate was significant from post-

test to midpoint, post-test to pretest, and midpoint to pretest. The participants in Group C

increased the amount of distance, duration, and rate walked from pretest to post-test by

26% (p = .002), 22% (p = .002), and 5% (p = .541) respectively. The TPHT found a

significant difference between the midpoint and pretest data of both the distance and

duration variables. To achieve the best results in distance, duration, and rate

improvements, a program of 10-14 weeks is the optimal length.














CHAPTER 1
INTRODUCTION

The purpose of this study was to determine the effects of the accommodating

pain-free walking exercise therapy program on exercise performance in patients with

intermittent claudication (IC) due to peripheral arterial disease (PAD). The null

hypothesis of this study was that the exercise program will not have an effect on exercise

performance. The alternative hypothesis of this study was that the exercise program will

have an effect on exercise performance. It is hypothesized that improvements in exercise

performance will occur and hopefully reduce cardiovascular morbidity and mortality

based on a review of the literature.

Definition of Terms

The following terms will be used frequently throughout the text, which are defined

as follows:

Accommodating pain-free (APF) refers to the exercise therapy protocol used in

this study. The belief held by researchers is that symptoms of peripheral arterial disease

(PAD) can be relieved by simply slowing down the walking speed at an individualized

level.

High-intensity exercise refers to walking on a treadmill at 80% maximum

workload.

Intermittent claudication (IC) refers to the symptom often felt by patients with

PAD. It is essentially pain in the legs upon exertion.









Low-intensity exercise refers to walking on a treadmill at 40% maximum

workload.

Near-maximal pain refers to walking on a treadmill to near-maximal pain

tolerance, resting until pain subsides, then resume walking.

Peripheral arterial disease (PAD) refers to a disease that causes the peripheral

arteries to become occluded and restrict blood flow.

Literature Review

The Centers for Disease Control (2005b) found that in 2002 there were 93,000

discharges of patients from hospitals in the United States listing peripheral arterial

disease (PAD) as their first-listed diagnosis. PAD consists of occlusions in the peripheral

arteries of the legs and it affects approximately 8 million to 10 million people in the

United States (Criqui, 2001; Stewart, Hiatt, Regensteiner, and Hirsch, 2002). PAD does

not directly cause mortality but it is a manifestation of coronary and cerebrovascular

disease which do cause mortality (Fuster, Moreno, Fayad, Corti, and Badimon, 2005b).

PAD is more specifically defined as a manifestation of systemic atherothrombosis (Hiatt,

2004). Systemic atherothrombosis is an arterial disease involving the intima (innermost

coat of an organ consisting of an endothelial layer backed by connective tissue and elastic

tissue) of large and medium sized arteries such as the carotid, aorta, coronary, and

peripheral (Fuster, Moreno, Fayad, Corti, and Badimon, 2005a). The manifestation of

this disease is defined as plaque build-up due to the following components: "1)

connective tissue extracellular matrix, including collagen, proteoglycans, and fibronectin

elastic fibers; 2) crystalline cholesterol, cholesterol esters, and phospholipids; 3) cells

such as monocyte-derived macrophages, T-lymphocytes, and smooth-muscle cells; and 4)

thrombotic material with platelets and fibrin deposition" (Fuster et al., 2005a, p. 937).









Hiatt (2004) clearly explained how to identify PAD by taking blood pressure

measurements in the ankles. A Doppler ultrasound device is used to obtain the systolic

blood pressures in the posterior tibial and dorsalis pedis vessels in the ankles and the

brachial pressure in the arm. The value is a ratio of ankle pressure to arm pressure.

Values of < 0.90 are indicative of PAD. In other words, when the blood pressure in the

ankle is lower than the blood pressure in the arm, this indicates an occlusion in the

peripheral arteries.

Intermittent claudication (IC) is the earliest and most frequent presenting

symptom of PAD that causes pain in the legs upon exertion (Ouriel, 2001). The pain is a

result of ischemic conditions occurring due to low amounts of blood supply to the

peripheral arteries during movement. Thirty percent of patients with IC die within five

years of the onset of symptoms (Carlon, Morlino, and Maiolino, 2003). Those with

claudication have had myocardial infarction or stroke in 20% to 30% of cases and

coronary disease in 50% to 70% of cases (Fuster et al., 2005b). In the United States, an

estimated 1.3 million elderly individuals will develop IC every two years for the next 50

years (Kakkos, Geroulakos, and Nicolaides, 2005). IC is the most common new problem

referred to vascular surgeons (Cheetham et al., 2004; Chong, Golledge, Greenhalgm, and

Davies, 2000).

Methods of managing IC include: lifestyle modifications, medications, surgery,

and exercise. Lifestyle modifications can include, but are not limited to, smoking

cessation (Hiatt, 2004), diet modification, and weight loss. Medications can include, but

are not limited to, aspirin (anti-platelet therapy), stations (lipid lowering agents) (Kakkos

et al., 2005; Cheetham et al., 2004; Pasupathy, Naseem, and Homer-Vanniasinkam, 2005;









Hiatt, 2004), anti-hypertension, diabetic therapy (Cheetham et al., 2004; Hiatt, 2004), and

proprionyl-L-carntitine (Hiatt, 2004). Surgeries can include, but are not limited to,

bypass and percutaneous transluminal angioplasty (PTA) (Krankenberg, Sorge, Zeller,

and Tubler, 2005). Due to the underlying atherothrombosis that accompanies IC, many

patients are not candidates for surgery because the surgery may present further

complications.

Exercises can include, but are not limited to, treadmill walking at an

accommodating pain-free intensity (Barak, 2004; Boyd et al., 1984; Marburger, 1992;

Martinez et al., 2005, Martinez, Stopka, and Stradley, 2006; Stopka et al., 1998), low and

high accommodating intensities (Slordahl et al., 2004; Gardner, Montgomery, Flinn, and

Katzel, 2005) and non-accommodating high intensities (Gardner and Poehlman, 1995).

Heel raises and cycle ergometers have been used as methods of exercise (Ng,

Hollingsworth, Luery, Kumana, and Chaloner, 2005), as well as resistance training.

Exercise

Exercise is a common treatment of IC and the effects have been studied for

decades. Exercise is considered one of the most effective interventions available for the

treatment of IC (Carlon et al., 2003; Treat-Jacobson and Walsh, 2003). Several

mechanisms are involved in this process: 1) peripheral blood flow redistribution, 2)

inhibition of the progression of atherosclerosis, 3) favorable hematologic alterations 4)

metabolic changes, 5) changes in muscle cell cytology and morphology, and 6) an

increased pain threshold (Carlon et al.; Remijnse-Tamerius, Duprez, De Buyzere,

Oeseburg, and Clement, 1999; Tan, De Cossart, and Edwards, 2000). Walking is the

preferred mode of exercise and improves the symptoms of claudication in several ways

(Ekroth, Dahllof, Gundevall, Holm, and Schersten, 1978; Foley, 1957; Larsen and









Lassen, 1966; Skinner and Strandness, 1967; Spronk, Dolman, Beolhouwer, Veen, and

den Hoed, 2003).

Near-Maximal Pain

As a result of extensive literature searches performed on PubMed and Science

Direct databases using PAD and exercise as search words, it appears that the near-

maximal pain method is the most widely used walking exercise therapy to date. The

belief held by many researchers and other medical professionals is that symptoms of IC

can be relieved by rest. Since the pain felt when walking is caused by an inadequate

blood supply to the muscles during exercise, it is relieved when activity ceases (Treat-

Jacobson et al., 2003). Therefore the walking therapy used by physicians and

researchers calls for the patients to walk to near-maximal pain tolerance, rest until pain

subsides, and then resume walking (Carlon et al., 2003; Gardner and Poehlman, 1995;

Hiatt, Regensteiner, Hargarten, Wolfel, and Brass, 1990; Hiatt, Wolfel, Meier, and

Regensteiner, 1994; Izquierdo-Porrera, Gardner, Powell, and Katzel, 2000; Lundgren,

Dahllof, Schersten, and Bylund-Fellensiu, 1989; Mannarino, Pasqualino, Menna,

Maragoni, and Orlandi, 1989; Santilli, Rodnick, and Santilli, 1996).

Exercise therapy used by Izquierdo-Porrera et al. (2000) required patients to

walk at 2 mph until their pain reached a level 3 on a 0 to 4 pain scale (0 = no pain, 1 =

onset of pain, 2 = moderate pain, 3 = intense pain, and 4 = maximal pain), after which

they rested. Five minutes of cycling on a stationary bicycle were used as warm-up and

cool down in each session. It is important to note that the American College of Sports

Medicine (ACSM) recommends the use of a maximal pain method as the only exercise

therapy for the treatment of IC (Mahler, Froelicher, Miller, and York, 1995).









Accommodating Pain-Free (APF) Walking Exercise Therapy

Accommodating pain-free (APF) walking exercise therapy for IC has recently

been introduced as an alternative method for walking exercise therapy (Martinez et al.,

2006). The belief held by researchers and other medical professionals is that symptoms

of IC can be relieved by simply slowing down the participant's walking speed. Many

authors suspect that exercise beyond the pain threshold might worsen blood flow or that

ischemia might induce the inflammation-mediated progression of atherosclerosis (Carlon

et al., 2003; Tisi and Shearman, 1998; Turton et al., 1998).

Those who use the accommodating pain-free method believe that further stress

on the arteries through a near-maximal pain walking therapy may only exacerbate other

underlying conditions such as cardiovascular events. For example, Carlon et al. (2003)

used the near-maximal pain therapy and excluded one patient because of their onset of

heart failure during the 10th exercise session. But the objective to involve oxidative

tissue through continuous aerobic training, plus the logic of more motivation and less

risky training has allowed for the emergence of an alternative training method.

This method, which was used in this study, calls for the patients to walk below

their maximal pain tolerance, slow down their walking when pain is barely felt, and then

increase their walking speed when the pain is no longer felt (Barak, 2004; Boyd et al.,

1984; Marburger, 1992; Martinez et al., 2005; Stopka et al., 1998).

Specifically, the exercise therapy used by Martinez et al. (2005) required

patients to walk continuously on a treadmill at a comfortable speed until their legs

reached an uncomfortable level of 0.5 on a 0 to 4 pain scale (0 = no symptoms, 0.5 =

tiredness, heaviness or tightness in legs without pain, 1 = tightness with definite, but mild

pain, 2 = starting to hurt with moderate, but distractible pain, 3 = definitely hurts with









severe, nondistractible pain, and 4 = must stop now with excruciating, unbearable pain)

after which they slowed down but did not stop walking. The patients were instructed to

walk as fast as possible without pain. When the patients felt pain they were instructed to

slow down their walking speed on the treadmill until they no longer felt pain. Once the

patients' pain had diminished they were instructed to increase their walking speed, again.

This process was repeated throughout the exercise session, comfortable training speeds

after the slower recovery walking, typically reach speeds higher than what had just

elicited the pain response.

Accommodating High and Low Intensity Training

Recent studies by Gardner et al. (2005) and Slordahl et al. (2004) have

investigated low-intensity versus high-intensity walking therapy. Gardner et al. defined

low-intensity as 40% of the participant's maximal workload while high-intensity was

defined as 80% of the participant's maximal workload. The therapy Gardner et al. used

remains unclear if an accommodating approach was used during exercise sessions.

However, Slordahl et al. defined low-intensity and high-intensity exactly the same as the

previous Gardner et al. example, but did clearly use an accommodating approach to the

exercise sessions, "since VO2 peak and work economy adapt to training, the work load

had to be adjusted during the training period to maintain the relative intensity level" (p.

246). But overall, these methods seem very similar to the near-maximal pain therapy

discussed above.

Pathophysiology

The interaction between the muscles and their much needed blood supply is very

specific. Factors such as muscle phenotype, muscle metabolic demands, arterial

thrombus formation, and arterial platelet activation are all very important factors in the









pathophysiology of the PAD. Understanding the pathophysiology behind PAD allows

researchers to relate improved fitness to other factors such as improved muscular

efficiency/oxygen use unlike the opinion ofNg et al. (2005) who believed that the

pathophysiology in improved fitness needed to remain a separate issue.

Askew et al. (2005) found that muscle phenotype is altered when patients with

PAD are compared with non-PAD controls. Specifically patients with PAD have a lower

amount of type I muscle fibers. Type I muscle fibers are classified as endurance fibers;

they are fatigue resistant and are found to be in great demand during marathons for

example. Unfortunately what patients with PAD have been shown to have are high

amounts of type II fibers. Type II fibers are used for a burst of energy such as a 100

meter track race. Type II fibers lead to fatigue and ultimately pain if used for a prolong

period of time. This finding explains why a person with IC feels pain when walking.

Hiatt (2004) stated that blood flow can't meet the metabolic demand of the

muscles in patients with IC. He stated that an increase in the level of acylcarnitine in

blood plasma of claudicants would indicate a metabolic disruption. Acyl-coenzyme A

(CoA) is an intermediate used in the Kreb's cycle for complete oxidation. An

accumulation of acyl-CoA would indicate incomplete oxidation or incomplete utilization.

Hiatt determined that a supplement of proprionyl-L-camitine would aid in the treatment

of IC by supplying needed nutrients to satisfy the metabolic demand of the muscles.

Killewich, Macko, Montgomery, Wiley, and Gardner (2004) stated that

"progression of atherosclerosis is also associated with thrombus formation" (p. 741)

which in turn reduces endogenous fibrinolysis. Fibrinolysis is "the system by which the

body lyses excess or inappropriately formed thrombus" (p. 741). Killewich et al.









determined that patients with PAD have impaired fibrinolytic activity but exercise

training reduced these impairments. Specifically exercise can increase tissue

plasminogen activator activity (tPA) and decrease plasminogen activator inhibitor-1

activity (PAl-1) which will in turn allow the body to lyse the thrombus formation and

essentially reduce the plaque build up in the peripheral arteries.

Pasupathy et al. (2004) stated that "exercise appears to induce an inflammatory

response in patients with claudication" (p. 50). High levels of platelet-leucocyte

aggregation (PLA) and platelet-neutrophil aggregation (PNA) may contribute to

morbidity and mortality in patients with PAD. The authors determined that levels of PLA

and PNA are increased after exercise in patients with claudication but diminished when a

warm-up was used. A warm-up was shown to delay claudication pain and therefore

improve the overall exercise capacity of the patients in the study. Clearly, further study

comparing low intensity training (eg. APF) to the currently recommended high intensity

(eg. Near-maximal pain) training on the inflammatory response is indicated.

Purpose

The purpose of this study was to determine the effects of the accommodating

pain-free (APF) walking exercise therapy program on exercise performance in patients

with intermittent claudication (IC) due to peripheral arterial disease (PAD). The null

hypothesis of this study was that the exercise program will not have an effect on exercise

performance. The alternative hypothesis of this study was that the exercise program will

have an effect on exercise performance. It is hypothesized that improvements in exercise

performance will occur and hopefully reduce cardiovascular morbidity and mortality

based on a review of the literature.















CHAPTER 2
MATERIALS AND METHODS

Principal Investigator

The principal investigator (P.I.) for this study has accumulated over 2400 hours

working with a variety of aspects concerning the accommodating pain-free (APF)

walking exercise therapy program. The P.I. began her involvement in 2003 when the

program was implemented at Fit for Life Fitness Center, Inc. From that point on, the P.I.

has been involved with patient training, volunteer training, data compilation, data

analysis, and submission of written and oral reports about the program. The P.I. was

personally involved with at least 20 of the participants in this study and the rest of the

data was collected by the research supervisor. It is important to note that this study is a

branch of a larger study that has been conducted for 25 years by the same research

supervisor.

Participants and Setting

Participants

All participants were referred from Gainesville, FL and Charlottesville, VA area

vascular surgeons and were screened for heart disease and found to have a present history

of peripheral arterial disease (PAD) with symptoms of intermittent claudication (IC).

The participants were recruited between 1980 and 2005 (1980-2003; research

supervisor's data and 2003-2005; P.I.'s data). Table 1 provides the general

characteristics of the study population.









The protocols for this study were approved by the Institutional Review Board at

the University of Florida and the University of Virginia to protect the rights and welfare

of the human participants involved. The participants were counseled on their rights as

well as potential risks and benefits of the program, prior to signing an informed consent

form.

Table 1. General characteristics of the study
population (n = 84)


M SD


Age (years) 68.73 9.19
Diabetes (%) 27.4
Female (%) 34.5
Heart Disease (%) 41.70
Hypercholesterol (%) 19
Hypertension (%) 47.6
Smoker (%) 12
Stroke (%) 7
Weeks in program 17 17


Instruments

The instruments used in the study consisted of the following:

Treadmills: in the following fitness centers: Fit for Life Fitness Center, Inc.,

Gainesville, FL and Living Well at the University of Florida, Gainesville, FL. Treadmills

at a University of Virginia research lab were also used. The treadmill speed began at 0.1

mph and increased in increments of 0.1 mph to a maximum speed of 12 mph.

Blood pressure equipment: standing, calibrated, manual aneroid manometer.

The blood pressure was measured in a seated position on the left upper arm with the palm

of the hand facing up.









Heart rate: to determine heart rate, the manual radial method was employed.

The heart rate was measured in a seated position on the left forearm just below the left

wrist. A 10-s pulse count was performed and the digit outcome was multiplied by 6 to

determine the participant's heart rate.

Exercise Settings

The APF walking exercise therapy program took place at Fit for Life Fitness

Center, Inc., Gainesville, FL, Living Well at the University of Florida, Gainesville, FL,

and at the Applied Physiology Laboratory in the Center for Physical Fitness at the

University of Virginia.

Procedures

The procedures of the study consisted of examining the improvement in walking

performance before, during and after the implementation of the APF walking exercise

therapy program. Group A (n = 28) participated in the program for two to nine weeks,

group B (n = 30) participated in the program for 10-14 weeks, and group C (n = 26)

participated in the program for 15-94 weeks.

The participants were notified by their physicians about the study. On the very

first day of the treatment program, the participants were oriented on the treatment

program goals and the rationales were carefully explained. Written copies of the goals

and rationale were given to the participants for their records (see Appendix A). The

participants then completed the Claudication Questionnaire to assess and document the

nature of their pain (see Appendix B). The participants also completed a Medical History

Questionnaire from the therapy facility to evaluate the safety of the participants'

involvement in an exercise program (see Appendix C). Further demographic information

was also obtained for administrative purposes (see Appendix D). Finally, if the









participants were still interested in joining the exercise program, they were instructed to

read and sign the Informed Consent form (see Appendix E). The participants kept a

signed Informed Consent form for their records and a signed Informed Consent form was

kept in their files at the therapy facility.

Upon completion of the treatment orientation, the first exercise session was

conducted. It was made very clear that the program once started could be discontinued

by the participants at any time and that the program was free of charge for the first six

weeks of treatment. Following the first six weeks of treatment, the participants were

asked to become a member of Fit for Life Fitness Center, Inc. or pay a guest fee to

continue with the accommodating pain-free walking exercise therapy program. The

participants were not asked to become members at the other therapy facilities.

Treatment Protocol

The treatment protocol used in this study was the APF Walking Exercise

Therapy for PAD where the IC symptoms can be relieved by simply slowing down the

participant's walking speed (Martinez et al., 2006).

At the beginning of each treatment session blood pressure and heart rate

measurements were conducted. Immediately before walking on the treadmill, the

participants actively participated in a series of therapeutic stretches with the contraction

enhancing hold-relax method of proprioceptive neuromuscular facilitation (PNF) (see

Appendix F). The purpose of the therapeutic stretches was to help relax the muscles and

prevent injury from the treadmill regimen, as well as to treat any pre-existing muscular

imbalances, hypertonias, etc.

The participants walked on a treadmill immediately after stretching. The

participants began and ended with a warm-up and cool down phase respectively. Each









phase lasted approximately 7 minutes. The warm-up and cool down phase consisted of

walking at a slow rate when compared to the participant's "normal speed." After a warm

up, the speed of the treadmill was increased by increments of 0.1 mph or 0.2 mph in 5 to

7 minute intervals. The participants found an optimal speed of the treadmill and stayed at

that speed for 10-15 minutes. When IC pain was felt by the participants to a degree of

0.5 to 1 on the IC Pain Scale (see Table 2) the speed of the treadmill was reduced by

approximately 0.5 mph. The participants continued to walk with the reduced speed until

the symptoms of IC pain diminished. Time until the pain diminished varied from 1 to 5

minutes. When the pain diminished, the treadmill speed gradually increased until the

participants were walking 0.1 mph, or higher, than the original speed that elicited the IC

symptoms. This speed adjustment protocol continued throughout the session to ensure

that the participants were always walking at their optimal (aerobic, continuous) training

rate (as fast as possible without pain). An accommodating intensity walking cool down

ended the walking session. The walking sessions ranged from 30 to 50 minutes. The

exercise sessions were conducted twice a week for approximately 60 minutes. The data

obtained before, during, and after the exercise session were recorded on an exercise

training log (see Appendix G).

Measures

The measure used in the study consisted of the following:

1. Pretest: Average of first and second session
2. Midpoint: Average of first and second midpoint session
3. Post-test: Average of next to last and last session
4. Walking rate (mi/hr): total distance / total duration
5. Percent improvement: (post exercise value pre exercise value) / pre
exercise value x 100









Research Design

Observations were obtained during each treatment meeting of the participants.

An average of the dependent variables from pretest to midpoint to post-test was

calculated. The research design used was a pretest post-test randomized group design for

three testing sessions.

Variables

The purpose of this study was to determine the effects of the accommodating

pain-free walking exercise therapy program on exercise performance in patients with IC

due to PAD. To investigate this question, EP (exercise performance) served as the

dependent variable and was measured on an interval/ratio scale. The APF walking

exercise therapy served as the independent variable and was measured on a

nominal/ordinal scale.

The EP Dependent Variables (Exercise Performance)

To examine the changes throughout the treatment program the following EP

variables were analyzed:

Walking distance: recorded directly from the treadmill's screen at the end of

the exercise.

Walking duration: recorded directly from the treadmill's screen at the end of

the exercise session.

Walking rate: was calculated using the data obtained from the previous two

variables.

Independent Variable

The independent variable used in the study consisted of the APF Walking

Exercise Therapy program (Martinez et al., 2006).









Data Analysis

The general characteristics of the study population (see Table 1) were generated

from Epi Info Version 3.3.2. Epi Info is a computer program used by epidemiologists

and other public health and medical professionals to rapidly develop questionnaires,

customize the data entry process, and enter and analyze data (Centers for Disease

Control, 2005a)

The statistical program SPSS 12.0 was used to analyze the data and examine

changes in the pretest, midpoint, and post-test walking performance variables using a

repeated measures design (ANOVA) with an alpha level of 0.05 to determine statistical

significance. If there was a significant F-value, the Tukey Post Hoc Test was used to

determine further significance between the groups. Repeated measures ANOVA was

used due to the following assumptions: the means were acquired with random selection,

the data was normally distributed, the sample means and sample standard deviations were

known, the population standard deviations and means were not known, the dependent

variable was on an interval/ratio scale, and the independent variable was on a

nominal/ordinal scale. Ho: l = [t2 = [t3; there is no difference between improvements in

exercise performance and the APF exercise therapy program. Ha: tl k t2 [t3; there

will be a difference between improvements in exercise performance and the APF exercise

therapy program. All data are presented as mean, standard deviation and percent

improvement.













Table 2. Intermittent claudication (IC) pain scale


0 NO SYMPTOMS
0.5 TIREDNESS, HEAVINESS OR TIGHTNESS IN LEGS
without pain
1 TIGHTNESS with definite, but mild pain
2 STARTING TO HURT with moderate, but distractible
pain
3 DEFINITELY HURTS with severe, nondistractible
pain
4 MUST STOP NOW with excruciating, unbearable pain


Note: From Stopka et al.,1998














CHAPTER 3
RESULTS

Group A

Group A (n = 28) participated in the program for 2 to 9 weeks.

Total Distance Walked

Table 3 provides a summary of the repeated measures ANOVA test. The

critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| > 3.17. F was

equal to 30.45, therefore the F-value is greater than the critical region, 30.45 > 3.17. The

null hypothesis was rejected, Ho: [l = a2 = a3; there is no difference between

improvements in exercise performance and the accommodating pain-free (APF) exercise

therapy program. The alternative hypothesis was assumed, Ha: tl a2 a3; there is a

difference between improvements in exercise performance and the APF exercise therapy

program.

Table 4 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc Test

found that T = .15. The mean difference of the post-test and pretest was greater than the

T-value, .47 > .15, reject Ho: [tl = t2 = [t3; there is no difference between improvements

in exercise performance and the APF exercise therapy program. Assume Ha: tl u2 2

[3; there is a difference between improvements in exercise performance and the APF

exercise therapy program. The mean difference of the midpoint and pretest was greater

than the T-value, .37 > .15, reject Ho: 1l = [2 = [3; there is no difference between

improvements in exercise performance and the APF exercise therapy program. Assume

Ha: tl / ja2 [t3; there is a difference between improvements in exercise performance









and the APF exercise therapy program. The mean difference of the post-test and

midpoint was less than the T-value, .1 < .15, reject Ha: Il 2 [t3; there is a difference

between improvements in exercise performance and the APF exercise therapy program.

Assume Ho: l = [t2 = [3; there is no difference between improvements in exercise

performance and the APF exercise therapy program.

Table 5 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest distance was .59 miles while the mean midpoint

distance was .96 miles, and the mean post-test distance was 1.06 miles. The repeated

measures ANOVA and Tukey Post Hoc Test found that the difference between the post-

test and pretest distance and the midpoint and pretest distance was significant.

Total Duration Walked

Table 6 provides a summary of the repeated measures ANOVA test. The critical

value (C.V.) was F = 3.17 and the critical region (C.R.) was FI > 3.17. F was equal to

15.34, therefore the F-value is greater than the critical region, 15.34 > 3.17. The null

hypothesis was rejected, Ho: [l = a2 = a3; there is no difference between improvements

in exercise performance and the APF exercise therapy program. The alternative

hypothesis was assumed, Ha: tl 42 i a3; there is a difference between improvements

in exercise performance and the APF exercise therapy program.

Table 7 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc

Test found that T = 4.42. The mean difference of the post-test and pretest was greater

than the T-value, 9.78 > 4.42, reject Ho: 1l = a2 = a3; there is no difference between

improvements in exercise performance and the APF exercise therapy program. Assume

Ha: tl i [C2 i a3; there is a difference between improvements in exercise performance

and the APF exercise therapy program. The mean difference of the midpoint and pretest









was greater than the T-value, 7.16 > 4.42, reject Ho: tl = at2 = a3; there is no difference

between improvements in exercise performance and the APF exercise therapy program.

Assume Ha: tl a2 a3; there is a difference between improvements in exercise

performance and the APF exercise therapy program. The mean difference of the post-test

and midpoint was less than the T-value, 2.62 < 4.42, reject Ha: tl [a2 at3; there is a

difference between improvements in exercise performance and the APF exercise therapy

program. Assume Ho: tl = at2 = a3; there is no difference between improvements in

exercise performance and the APF exercise therapy program.

Table 8 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest duration was 25.95 minutes while the mean

midpoint duration was 33.11 minutes, and the mean post-test duration was 35.73 minutes.

The repeated measures ANOVA and Tukey Post Hoc Test found that the difference

between the post-test and pretest duration and the midpoint and pretest duration was

significant.

Total Walking Rate

Table 9 provides a summary of the repeated measures ANOVA test. The critical

value (C.V.) was F = 3.17 and the critical region (C.R.) was FI > 3.17. F was equal to

14.64, therefore the F-value is greater than the critical region, 14.64 > 3.17. The null

hypothesis was rejected, Ho: tl = at2 = a3; there is no difference between improvements

in exercise performance and the APF exercise therapy program. The alternative

hypothesis was assumed, Ha: tl i [a2 i at3; there is a difference between improvements

in exercise performance and the APF exercise therapy program.

Table 10 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc

Test found that T = .27. The mean difference of the post-test and pretest was greater than









the T-value, .48 > .27, reject Ho: l = a2 = a3; there is no difference between

improvements in exercise performance and the APF exercise therapy program. Assume

Ha: Il [C2 a3; there is a difference between improvements in exercise performance

and the APF exercise therapy program. The mean difference of the midpoint and pretest

was greater than the T-value, .33 > .27, reject Ho: [l = a2 = a3; there is no difference

between improvements in exercise performance and the APF exercise therapy program.

Assume Ha: Il a2 a3; there is a difference between improvements in exercise

performance and the APF exercise therapy program. The mean difference of the post-test

and midpoint was less than the T-value, .15 < .27, reject Ha: tl a2 a3; there is a

difference between improvements in exercise performance and the APF exercise therapy

program. Assume Ho: l = a2 = a3; there is no difference between improvements in

exercise performance and the APF exercise therapy program.

Table 11 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest rate was 1.31 mi/hr while the mean midpoint rate

was 1.64 mi/hr, and the mean post-test rate was 1.8 mi/hr. The repeated measures

ANOVA and Tukey Post Hoc Test found that the difference between the post-test and

pretest rate and the midpoint and pretest rate was significant.

Group B

Group B (n = 30) participated in the program for 10 to 14 weeks.

Total Distance Walked

Table 12 provides a summary of the repeated measures ANOVA test. The

critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| > 3.17. F was

equal to 34.32, therefore the F-value is greater than the critical region, 34.32 > 3.17. The

null hypothesis was rejected, Ho: tl = a2 = [a3; there is no difference between









improvements in exercise performance and the APF exercise therapy program. The

alternative hypothesis was assumed, Ha: k1l / [C2 [3; there is a difference between

improvements in exercise performance and the APF exercise therapy program.

Table 13 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc

Test found that T = .2. The mean difference of the post-test and pretest was greater than

the T-value, .62 > .2, reject Ho: ktl = [t2 = t3; there is no difference between

improvements in exercise performance and the APF exercise therapy program. Assume

Ha: ktl [2 :t3; there is a difference between improvements in exercise performance

and the APF exercise therapy program. The mean difference of the midpoint and pretest

was greater than the T-value, .56 > .2, reject Ho: [tl = [t2 = t3; there is no difference

between improvements in exercise performance and the APF exercise therapy program.

Assume Ha: ktl [2 [t3; there is a difference between improvements in exercise

performance and the APF exercise therapy program. The mean difference of the post-test

and midpoint was less than the T-value, .06 < .2, reject Ha: 1tl [C2 [t3; there is a

difference between improvements in exercise performance and the APF exercise therapy

program. Assume Ho: ktl = [t2 = t3; there is no difference between improvements in

exercise performance and the APF exercise therapy program.

Table 14 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest distance was .51 miles while the mean midpoint

distance was 1.07 miles, and the mean post-test distance was 1.13 miles. The repeated

measures ANOVA and Tukey Post Hoc Test found that the difference between the post-

test and pretest distance and the midpoint and pretest distance was significant.









Total Duration Walked

Table 15 provides a summary of the repeated measures ANOVA test. The

critical value (C.V.) was F = 3.17 and the critical region (C.R.) was |F| > 3.17. F was

equal to 25.91, therefore the F-value is greater than the critical region, 25.91 > 3.17. The

null hypothesis was rejected, Ho: pl = a2 = a3; there is no difference between

improvements in exercise performance and the APF exercise therapy program. The

alternative hypothesis was assumed, Ha: pl 2 a3; there is a difference between

improvements in exercise performance and the APF exercise therapy program.

Table 16 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc

Test found that T = 4.99. The mean difference of the post-test and pretest was greater

than the T-value, 11.14 > 4.99, reject Ho: pl = a2 = a3; there is no difference between

improvements in exercise performance and the APF exercise therapy program. Assume

Ha: pl [C2 [a3; there is a difference between improvements in exercise performance

and the APF exercise therapy program. The mean difference of the midpoint and pretest

was greater than the T-value, 14.09 > 4.99, reject Ho: pl = a2 = a3; there is no difference

between improvements in exercise performance and the APF exercise therapy program.

Assume Ha: pl [2 a3; there is a difference between improvements in exercise

performance and the APF exercise therapy program. The mean difference of the post-test

and midpoint was less than the T-value, -2.95 < 4.99, reject Ha: pl a2 a3; there is a

difference between improvements in exercise performance and the APF exercise therapy

program. Assume Ho: pl = a2 = a3; there is no difference between improvements in

exercise performance and the APF exercise therapy program.

Table 17 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest duration was 19.73 minutes while the mean









midpoint duration was 33.82 minutes, and the mean post-test duration was 30.87 minutes.

The repeated measures ANOVA and Tukey Post Hoc Test found that the difference

between the post-test and pretest duration and the midpoint and pretest duration was

significant.

Total Walking Rate

Table 18 provides a summary of the repeated measures ANOVA test. The

critical value (C.V.) was F = 3.17 and the critical region (C.R.) was F| > 3.17. F was

equal to 26.53, therefore the F-value is greater than the critical region, 26.53 > 3.17. The

null hypothesis was rejected, Ho: [l = a2 = a3; there is no difference between

improvements in exercise performance and the APF exercise therapy program. The

alternative hypothesis was assumed, Ha: tl a2 a3; there is a difference between

improvements in exercise performance and the APF exercise therapy program.

Table 19 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc

Test found that T = .22. The mean difference of the post-test and pretest was greater than

the T-value, .64 > .22, reject Ho: 1l = a2 = a3; there is no difference between

improvements in exercise performance and the APF exercise therapy program. Assume

Ha: tl [C2 a3; there is a difference between improvements in exercise performance

and the APF exercise therapy program. The mean difference of the midpoint and pretest

was greater than the T-value, .36 > .22, reject Ho: [l = a2 = a3; there is no difference

between improvements in exercise performance and the APF exercise therapy program.

Assume Ha: tl a2 a3; there is a difference between improvements in exercise

performance and the APF exercise therapy program. The mean difference of the post-test

and midpoint was greater than the T-value, .28 >.22, reject Ho: 1l = a2 = a3; there is no

difference between improvements in exercise performance and the APF exercise therapy









program. Assume Ha: Il a2 a3; there is a difference between improvements in

exercise performance and the APF exercise therapy program.

Table 20 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest rate was 1.48 mi/hr while the mean midpoint rate

was 1.84 mi/hr, and the mean post-test rate was 2.12 mi/hr. The repeated measures

ANOVA and Tukey Post Hoc Test found that the difference between the post-test and

pretest rate and the midpoint and pretest rate and the post-test and midpoint rate was

significant.

Group C

Group C (n = 26) participated in the program for 15 to 94 weeks.

Total Distance Walked

Table 21 provides a summary of the repeated measures ANOVA test. The

critical value (C.V.) was F = 3.18 and the critical region (C.R.) was F| > 3.18. F was

equal to 7.4, therefore the F-value is greater than the critical region, 7.4 > 3.18. The null

hypothesis was rejected, Ho: [tl = [t2 = [t3; there is no difference between improvements

in exercise performance and the APF exercise therapy program. The alternative

hypothesis was assumed, Ha: t1l / j[2 / [t3; there is a difference between improvements

in exercise performance and the APF exercise therapy program.

Table 22 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc

Test found that T = .22. The mean difference of the post-test and pretest was less than

the T-value, .19 < .22, reject Ha: t1l j[2 [t3; there is a difference between

improvements in exercise performance and the APF exercise therapy program. Assume

Ho: tl = [C2 = t3; there is no difference between improvements in exercise performance

and the APF exercise therapy program. The mean difference of the midpoint and pretest









was greater than the T-value, .35 > .22, reject Ho: [l = a2 = a3; there is no difference

between improvements in exercise performance and the APF exercise therapy program.

Assume Ha: Il a2 a3; there is a difference between improvements in exercise

performance and the APF exercise therapy program. The mean difference of the post-test

and midpoint was less than the T-value, -.16 < .22, reject Ha: tl a2 a3; there is a

difference between improvements in exercise performance and the APF exercise therapy

program. Assume Ho: l = a2 = a3; there is no difference between improvements in

exercise performance and the APF exercise therapy program.

Table 23 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest distance was .72 miles while the mean midpoint

distance was 1.07 miles, and the mean post-test distance was .91 miles. The repeated

measures ANOVA and Tukey Post Hoc Test found that the difference between the

midpoint and pretest distance was significant.

Total Duration Walked

Table 24 provides a summary of the repeated measures ANOVA test. The

critical value (C.V.) was F = 3.18 and the critical region (C.R.) was |F| > 3.18. F was

equal to 6.9, therefore the F-value is greater than the critical region, 6.9 > 3.18. The null

hypothesis was rejected, Ho: l = [t2 = [3; there is no difference between improvements

in exercise performance and the APF exercise therapy program. The alternative

hypothesis was assumed, Ha: tl / [C2 / [t3; there is a difference between improvements

in exercise performance and the APF exercise therapy program.

Table 25 provides a summary of the Tukey Post Hoc Test. The Tukey Post Hoc

Test found that T = 5.72. The mean difference of the post-test and pretest was less than

the T-value, 5.1 < 5.72, reject Ha: tl [2 [t3; there is a difference between









improvements in exercise performance and the APF exercise therapy program. Assume

Ho: ktl = [2 = t3; there is no difference between improvements in exercise performance

and the APF exercise therapy program. The mean difference of the midpoint and pretest

was greater than the T-value, 8.74 > 5.72, reject Ho: [tl = [t2 = t3; there is no difference

between improvements in exercise performance and the APF exercise therapy program.

Assume Ha: k1l [2 :3; there is a difference between improvements in exercise

performance and the APF exercise therapy program. The mean difference of the post-test

and midpoint was less than the T-value, -3.64 < 5.72, reject Ha: k1l [t2 j t3; there is a

difference between improvements in exercise performance and the APF exercise therapy

program. Assume Ho: ktl = [t2 = t3; there is no difference between improvements in

exercise performance and the APF exercise therapy program.

Table 26 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest duration was 22.82 minutes while the mean

midpoint duration was 31.56 minutes, and the mean post-test duration was 27.92 minutes.

The repeated measures ANOVA and Tukey Post Hoc Test found that the difference

between the midpoint and pretest duration was significant.

Total Walking Rate

Table 27 provides a summary of the repeated measures ANOVA test. The

critical value (C.V.) was F = 3.18 and the critical region (C.R.) was F| > 3.18. F was

equal to .62, therefore the F-value is less than the critical region, .62 < 3.18. The

alternative hypothesis was rejected, Ha: k1l [t2 i t3; there is a difference between

improvements in exercise performance and the APF exercise therapy program. The null

hypothesis was assumed, Ho: ktl = t2 = t3; there is no difference between improvements

in exercise performance and the APF exercise therapy program.










Table 28 provides a summary of the pretest, midpoint, and post-test means and

standard deviations. The mean pretest rate was 1.8 mi/hr while the mean midpoint rate

was 1.92 mi/hr, and the mean post-test rate was 1.89 mi/hr. The repeated measures

ANOVA test found that the difference between the post-test, midpoint, and pretest rate

was not significant.

Table 3. Summary ANOVA for differences in pretest, midpoint, and post-test
distance (miles) markers in the APF walking exercise therapy for PAD. Group A


Source SS df MS F


Treat 3.42 2 1.71 30.45*

Within 17.23 81 0.21

Between Subjects 14.21 27 0.53

Error 3.03 54 0.06


Total 20.65 83


*p < .05; F(.05) = 3.17











Table 4. Ordered mean differences on the effects of the APF exercise
walking therapy for PAD on group A distance (miles) performance
using a Tukey Post Hoc Test


Group Means (distance walked)


Post-test Midpoint Pretest Mean Diff


1.06 0.96 0.1

1.06 0.59 0.47*

0.96 0.59 0.37*


*p < .05; T(.05) = .15


Table 5. Group A's mean and standard deviation of distance (miles)
walked from pretest, midpoint, to post-test.


Pre MP Post


M 0.59 0.96 1.06

SD 0.35 0.53 0.49











Table 6. Summary ANOVA for differences in pretest, midpoint, and post-test
duration (minutes) markers in the APF walking exercise therapy for PAD. Group A


Source SS df MS F


Treat 1436 2 718 15.34*

Within 8305 81 102

Between Subjects 5776 27 214

Error 2529 54 46.84


Total 9741 83


*p< .05; F(.05) = 3.17


Table 7. Ordered mean differences on the effects of the APF walking
exercise therapy for PAD on duration (minutes) performance
using a Tukey Post Hoc Test. Group A


Group Means (duration walked)


Post-test Midpoint Pretest Mean Diff


35.73 33.11 2.62

35.73 25.95 9.78*

33.11 25.95 7.16*


*p < .05; T(.05) = 4.42











Table 8. Group A's mean and standard deviation of duration (minutes) walked
From pretest, midpoint, to post-test.


Pre MP Post


M 25.95 33.11 35.73

SD 8 10.56 11.49


Table 9. Summary ANOVA for differences in pretest, midpoint, and post-test
rate (mi/hr) markers in the APF walking exercise therapy for PAD. Group A


Source SS df MS F


Treat 3.46 2 1.73 14.64*

Within 26 81 0.33

Between Subjects 20 27 0.75

Error 6.38 54 0.19


Total 29.46 83

*p < .05; F(.05) = 3.17











Table 10. Ordered mean differences on the effects of the APF walking
exercise therapy for PAD on group A rate (mi/hr) performance
using a Tukey Post Hoc Test


Group Means (walking rate)


Post-test Midpoint Pretest Mean Diff


1.79 1.64 0.15

1.79 1.31 0.48*

1.64 1.31 0.33*


*p < .05; T(.05) = .27


Table 11. Group A's mean and standard deviation of rate (mi/hr)
walked from pretest, midpoint, to post-test.


Pre MP Post


M 1.31 1.64 1.8

SD 0.55 0.6 0.57











Table 12. Summary ANOVA for differences in pretest, midpoint, post-test
distance (miles) markers in the APF walking exercise therapy for PAD. Group B


Source SS df MS F


Treat 7.08 2 3.54 34.32*

Within 21.94 87 0.25

Between Subjects 15.95 29 0.55

Error 5.98 58 0.1


Total 29.02 89


*p < .05; F(.05) = 3.17


Table 13. Ordered mean differences on the effects APF walking
exercise therapy for PAD on group B distance (miles) performance
using a Tukey Post Hoc Test


Group Means (walking distance)


Post-test Midpoint Pretest Mean Diff


1.13 1.07 0.06

1.13 0.51 0.62*

1.07 0.51 0.56*


*p < .05; T(.05) = .2











Table 14. Group B's mean and standard deviation of distance (miles)
walked from pretest, midpoint, to post-test.


Pre MP Post


M 0.51 1.07 1.13

SD 0.31 0.55 0.6


Table 15. Summary ANOVA for differences in pretest, midpoint, and post-test
duration (minutes) markers in the APF walking exercise therapy for PAD. Group B


Source SS df MS F


Treat 3310 2 1655 25.91*

Within 9654 87 110

Between Subjects 5949.56 29 205

Error 3705 58 63.89


Total 12964 89


*p < .05; F(.05) = 3.17











Table 16. Ordered mean differences on the effects of the APF
walking exercise therapy for PAD on group B duration (minutes)
performance using a Tukey Post Hoc Test


Group Means (walking duration)


Post-test Midpoint Pretest Mean Diff


30.87 33.82 -2.95

30.87 19.73 11.14*

33.82 19.73 14.09*


*p < .05; T(.05) = 4.99


Table 17. Group B's mean and standard deviation of duration (minutes)
walked from pretest, midpoint, to post-test.


Pre MP Post


M 19.73 33.82 30.87

SD 7.61 11.89 11.56











Table 18. Summary ANOVA for differences in pretest, midpoint, and post-test
rate (mi/hr) markers in the APF walking exercise therapy for PAD. Group B


Source SS df MS F


Treat 6.09 2 3.04 26.53*

Within 33.78 87 0.39

Between Subjects 27 29 0.94

Error 6.66 58 0.12


Total 39.87 89


*p < .05; F(.05) = 3.17


Table 19. Ordered mean differences on the effects of the APF
walking exercise therapy for PAD on group B rate (mi/hr) performance
using a Tukey Post Hoc Test


Group Means (walking rate)


Post-test Midpoint Pretest Mean Diff


2.12 1.84 0.28*

2.12 1.48 0.64*

1.84 1.48 0.36*


*p < .05; T(.05) = .22











Table 20. Group B's mean and standard deviation of rate (mi/hr) walked from
pretest, midpoint, to post-test.


Pre MP Post


M 19.73 33.82 30.87

SD 7.61 11.89 11.56


Table 21. Summary ANOVA for differences in pretest, midpoint, and post-test
distance (miles) markers in the APF walking exercise therapy for PAD. Group C


Source SS df MS F


Treat 1.59 2 0.79 7.4*

Within 23.33 75 0.31

Between Subjects 17.97 25 0.72

Error 5.37 50 0.11


Total 24.92 77


*p < .05; F(.05) = 3.18











Table 22. Ordered mean differences on the effects of the APF
walking exercise therapy for PAD on group C distance (miles) performance
using a Tukey Post Hoc Test


Group Means (distance walked)


Post-test Midpoint Pretest Mean Diff


0.91 1.07 -0.16

0.91 0.72 0.19

1.07 0.72 0.35*


*p < .05; T(.05) = .22



Table 23. Group C's mean and standard deviation of distance (miles)
walked from pretest, midpoint, to post-test.


Pre MP Post


M 0.72 1.07 0.91

SD 0.53 0.58 0.56











Table 24. Summary ANOVA for differences in pretest, midpoint, and post-test
duration (minutes) markers in the APF walking exercise therapy for PAD. Group C


Source SS df MS F


Treat 1002 2 501 6.9*

Within 10609 75 141

Between Subjects 6976 25 279

Error 3632 50 72.66


Total 11611 77


*p< .05; F(.05) = 3.18


Table 25. Ordered mean differences on the effects of the APF walking
exercise therapy for PAD on group C duration (minutes) performance
using a Tukey Post Hoc Test


Group Means (minutes walked)


Post-test Midpoint Pretest Mean Diff


27.92 31.56 -3.64

27.92 22.82 5.1

31.56 22.82 8.74*


*p < .05; T(.05) = 5.72











Table 26. Group C's mean and standard deviation of duration walked
from pretest, midpoint, to post-test.


Pre MP Post


M 22.82 31.56 27.92

SD 10.07 11.44 13.87


Table 27. Summary ANOVA for differences in pretest, midpoint, and post-test
rate (mi/hr) markers in the APF walking exercise therapy for PAD. Group C


Source SS df MS F


Treat 0.22 2 0.11 0.62

Within 36.83 75 0.49

Between Subjects 28 25 1.13

Error 8.67 50 0.17


Total 37.05 77


p > .05; F(.05) = 3.18


Table 28. Group C's mean and standard deviation of rate (mi/hr) walked
from pretest, midpoint, to post-test.


Pre MP Post


M 1.8 1.92 1.89

SD 0.75 0.72 0.62














CHAPTER 4
DISCUSSION

The alternative hypothesis of this study was that the accommodating pain-free

(APF) walking exercise therapy for peripheral arterial disease (PAD) would have an

effect on exercise performance in patients with intermittent claudication (IC) due to PAD.

The results indicate that the walking program did indeed have an effect on exercise

performance.

Group A

The participants increased the amount of distance, duration, and rate walked

from pretest to post-test by 80% (p < .001), 27% (p < .001), and 37% (p < .001)

respectively. The Tukey Post Hoc Test found a significant difference between the post-

test and pretest and between the midpoint and pretest. A goal of this therapy program is

to increase the participants' distance, duration, and rate from their first session to their

last session, so it is expected that the findings are significant from pretest to post-test.

Also, significance was found between the pretest and midpoint which implies that for this

group of participants their exercise performance is improving significantly by the

midpoint of their therapy.

The program length for this group of participants was 2 to 9 weeks. Therefore,

a program that has a similar time span could feel confident that the length is optimal and

positive results can be ascertained as soon as the midpoint of the program.









Group B

The participants increased the amount of distance, duration, and rate walked

from pretest to post-test by 122% (p < .001), 56% (p < .001), and 43% (p < .001)

respectively. The Tukey Post Hoc Test found a significant difference between the pretest

and post-test and pretest and midpoint variables of both the distance and duration

variables. These findings indicate that once again the goal of increasing exercise

performance from pretest to post-test was in fact met as well as increasing exercise

performance from pretest to midpoint was met in accordance with Group A. The Tukey

Post Hoc Test further revealed that rate was significant from post-test to midpoint, post-

test to pretest, and midpoint to pretest.

It appears that a program length of 10-14 weeks is the most efficient length to

produce significant rate results throughout the duration of the program. Group B's rate

results are very positive. Recall that the population in this study is defined as elderly and

one of their limitations other than walking with pain is that they walk to slow. Many of

the patients reported to the P.I. under informal conditions that they would like to be able

to walk with their grandchildren rather than feel as if they are holding the children back.

Therefore, a person attending the program from 10-14 weeks could expect to increase

their rate through the duration of the program.

Group C

The participants increased the amount of distance, duration, and rate walked

from pretest to post-test by 26% (p = .002), 22% (p = .002), and 5% (p = .541)

respectively. The Tukey Post Hoc Test found a significant difference between the

midpoint and pretest data of both the distance and duration variables. The rate for this

group was not found to be significant at all. This group participated in the program from









15-94 weeks. The data for this group can be misleading and can be misinterpreted. The

reason for such a lack of improvement percentage and/or a lack of significance of the

findings is simply due to the participants' maintenance of the program.

Once the participants have become accustomed to the program and have trained

their minds and bodies to walk without pain they stop improving and start maintaining

their new level of exercise. Leisure athletes maintain their exercise levels, they generally

find a point that they can maintain week after week and stay there unless they are training

for a race. So essentially group C represents the maintenance stage of the program. The

participants may not be walking as fast as they were during their midpoint but they are

still walking without pain and maintaining all of their improvements in exercise

performance. Furthermore, if the participants were to continue to increase their rate, they

would probably be jogging instead of walking.

Groups A, B, and C

"The three goals of the APF exercise therapy are as follows: To have the

participants walk farther, longer, and faster without pain to improve their functional

ability and social interaction" (Martinez et al., 2006, p. 46).

Groups A, B, and C increased their distance walked by 80% (p < .001), 122% (p

< .001), and 26% (p = .002) respectively. Figure 1 contains the distance totals for each

group from pretest to midpoint to post-test. The groups increased their duration walked

by 27% (p < .001), 56% (p < .001), and 22% (p = .002) respectively. Figure 2 contains

the duration totals for each group from pretest to midpoint to post-test. Finally, the

groups increased their rate walked by 37% (p < .001), 43% (p < .001), and 5% (p = .541).

Figure 3 contains the rate totals for each group from pretest to midpoint to post-test.










Clearly, in order to produce the most improvement in exercise performance the

optimal program length is 10-14 weeks (Group B). To produce the second best

improvement in exercise performance the optimal program length is 2-9 weeks (Group

A). Once the participants have reached 15 weeks and beyond they should be considered

in a maintenance stage and analyzed accordingly.


Pre 1 MP O Post


2
1.8 *-
1.6 *
1.4 *
1.2
0 1*
0.8 -
0.6 -
0.4 -
0.2
0
A B C
Total distance walked from pretest to midpoint to post-test



Figure 1. Effects of the APF walking exercise therapy for PAD on the amount of
distance (miles) walked from pretest to midpoint to post-test. Group A
represents program participation from 2-9 weeks. Group B represents
participation from 10-14 weeks. Group C represents program participation
from 15-94 weeks. = p < .05.












SPre t MP O Post

50 *
45 *
40
35 *
S30 -
25 -
20 -
15

5-
0
A B C
Total duration walked from pretest to midpoint to post-
test

Figure 2. Effects of the APF walking exercise therapy for PAD on the amount of
duration (minutes) walked from pretest to midpoint to post-test. Group A
represents program participation from 2-9 weeks. Group B represents
participation from 10-14 weeks. Group C represents program participation
from 15-94 weeks. = p < .05.


Pre o MP D Post

3 -

2.5 *

S2
o
1.5 '


0.5 -



A B C
Total walking rate from pretest to midpoint to post-test

Figure 3. Effects of the APF walking exercise therapy for PAD on the amount of velocity
(mi/hr) walked from pretest to midpoint to post-test. Group A represents
program participation from 2-9 weeks. Group B represents participation from
10-14 weeks. Group C represents program participation from 15-94 weeks. *
=p <.05.









Every group accomplished the first goal of the program which was to walk a farther

distance then they had been walking before the start of the program. The patient

population has difficulty walking around the grocery store without having to stop because

of leg pain. So if this program can at least allow the individual to walk through the store

without pain then the person has indeed increased their quality of life.

Further, the groups all accomplished the second and third goals of the program

which is to walk longer and faster. Therefore, the program participants can not only walk

through the grocery store without pain, they can also walk faster and longer to keep up

with their grandchildren.

Martinez et al. (2006) reviewed three studies that used the APF protocol:

Study one (Pena, Stopka, and Todorovich, 2003) had 13 participants (n =
13) with an average age of 71 years. The participants met for six weeks,
twice a week and had an average of 10 visits. Study two (Barak, Stopka,
Todorovich, and Siders, 2004) had 12 participants (n = 12). The
participants met for six weeks, twice a week. Study three (Martinez and
Stopka, 2005) had 10 participants (n = 10) with an average age of 73
years. The participants met for 8 weeks, twice a week. (p. 45)

The distance improvements were 148%, 105%, and 116% for studies 1, 2, & 3

respectively (p < .05). The duration improvements were 94%, 56%, and 50% for studies

1, 2, & 3 respectively (p < .05). The rate improvements were 34%, 41%, and 32% for

studies 1, 2, & 3 respectively (p < .05). The improvements found from Martinez et al. are

consistent with the findings from this study.

Stopka et al. (1998) used the APF exercise therapy and found an

improvement of 408.5% (p < .01) in distance, an improvement of 163.3% (p < .01) in

duration, and an improvement of 94.4% in rate (p < .01). The participants (n = 46)

attended therapy twice a week for 9 weeks. The findings in the Stopka et al. study are









clearly much higher than the findings from the present study. However, both studies had

significant improvements in all the exercise performance factors and serve as further

demonstration of the quality of the APF program for improving exercise performance.

Gardner and Poehlman (1995) determined through their meta-analysis that the

optimal program for treating IC due to PAD is three sessions per week for six months

walking at near-maximal pain. The results of their meta-analysis found that the distance

would improve by 122% (p < .001) if using their suggested program. All of the APF

studies cited in this discussion have either been close to, been exactly the same (Group B

of this study), or have usurped the expected 122% improvement of the near-maximal pain

training as advocated by Gardner and Poehlman (1995). Clearly the findings from the

APF protocol are consistent, or much stronger, with the findings from the Gardner and

Poehlman (1995 protocol considering the APF protocol was done twice a week versus 3

times a week; the APF protocol was 10-14 weeks versus 6 months. The main difference

is that the Gardner and Poehlman (1995) protocol elicits near-maximal pain while the

APF protocol advocates pain-free walking at all times.

A new trend in the literature is taking place now. Studies are starting to look at

the effects of low-intensity and high-intensity therapy (as noted in the introduction).

Gardner et al. (2005) looked at the distance improvements of both a low and high

intensity program. They found that after a 6 month program of 3 times a week that

absolute distance improved by 61% (p < .01) in the low-intensity group and by 63% (p <

.01) in the high-intensity group and initial distance improved by 109% (p < .01) in both

the low and high-intensity groups. The results of the APF studies used and cited in this









study are once again either slightly lower or greatly higher than the results of the Gardner

et al. study.

Limitations

First, repeated measures ANOVA was used based on a number of assumptions.

One of the assumptions stated in the data analysis subsection of the methods and

materials section was that the means were acquired with random selection. This

assumption is false. The participants were chosen for the program based on their current

diagnosis of IC and were not randomly selected. Further, the means were not acquired

randomly; they were specifically chosen to satisfy the parameters of the research

question. For example, the means for the pretest were chosen based on the participants'

first and second session.

Second, many experimental researchers believe that studies done without a

control group is invalid because control groups allow the researcher to compare. The

study here did not use a control group. Literature reviews have shown that exercise for

this population is imperative. This study would find it ethically wrong to exclude

patients from the program because they are controls. Those very controls could

experience further morbidity and/or mortality simply for serving as controls in our study.

Therefore, this study understands the importance of including everyone. Furthermore,

the research design used in this study is a valid, reliable, and established design and

should not be given less respect because of the lack of a comparison group.

Third, the P.I. did not take all of the original data from each participant. The

data were taken from over 20 years of program participants. However, the basic method

for compiling the data over the years was essentially the same (and supervised by the

same researcher). Therefore, the P.I. was able to successfully access and analyze the






49


needed data. Further, the volunteers involved with the program changed frequently over

the years and that could have made an impact on the success of the participants.

Fourth, all of the participants volunteered to be a member of the program.

Therefore, the participants may have already had a positive inclination towards exercise.














CHAPTER 5
CONCLUSION AND FUTURE DIRECTIONS

Conclusion

The above discussion clearly indicates that the accommodating pain-free (APF)

protocol is at the very least comparable if not better than the near-maximal and low and

high-intensity programs. The most important fact to remember when choosing between

the different protocols is to determine whether or not the participants will want to feel

pain while exercising. It has been evidenced by the P.I. in this study that elderly

individuals prefer not to feel pain while exercising and will stay with the program longer

when they enjoy themselves, as evidenced by the 26 participants in Group C who were

involved with the program in this study for 15-94 weeks. Finally, to achieve the best

results in distance, duration, and rate improvements, a program of 10-14 weeks is the

optimal length and this has great relevance for third party reimbursement policies due to

the briefer frequency and duration of sessions needed for improvement. It is

hypothesized the improvements demonstrated in exercise performance will hopefully

reduce the cardiovascular morbidity and mortality of all the participants based on a

review of the literature.

Future Directions

It is important to note that the pathophysiology stated in the introduction is

based on near-maximal pain exercise therapy. Boyd et al., 1984 used the APF protocol

and found that after 12 weeks, three times a week with eight participants that their

distance increased by 138% and their duration increased 103%. Boyd et al., 1984 further









found significant increases in pulse volume amplitude in the left calf and ankle. The

author suggested that further research be done to "examine the possibility of a large

vessel response to low level training intensities" pg. 120. The study also found

significant mean pre to post-training muscle blood flow increases.

To date, Boyd et al., 1984 is the only study found that has looked at the

pathophysiology of the APF protocol. There is a clear need to do more studies that

directly focus on the various pathophysiologies mentioned in the introduction as related

to the APF protocol. Until then, APF researchers can only speculate the reasons for

exercise performance while comparing to the established literature pathophysiology.

















APPENDIX A
GOALS AND RATIONALE



EXERCISE THERAPY
FOR
INTERMITTENT CLAUDICATION

Program Director: Dr. Christine Stopka

Definition of Intermittent Crlaut"ictinn
Intermiitent ClaudicaLion is a term used to describe the development of pain in the legs
due to poor circulation. The pain is usually caused by an imbalance between the body's
demand of the muscles and their blood supply during exercise. The pain usually manifests
itselfin the calf, thigh, or hips during exercise.

EPurpose
The purpose ofthis project is to improve functional capacity which includes improving
distance, rate, and time of your exercise, decreasing your claudication symptoms during
exercise and improving the efficiency of your working muscles so that more exercise can
be done without pain This will enable you to increase your ability to perform activities of
daily living and pursue your interest with as little pain as possible.

The Program
The program consists of 9 to 12 weeks of LOW INTESITY, PAIN FREE exercise on
the treadmill. The secret is to walk as fast as possible WITHOUT PAIN, when pain
begins. SLOW DOWN until it goes away. You will find you can walk faster, further and
longer every week if you stick with this PAIN FREE training program. A flexibility and
general conditioning program is included and an upper body strength training program can
be included as well if so desired. All participants are asked to exercise two days a week
for approximately 45 minutes

Results
For our forty participants since 1991, results revealed a 402% improvement in pain free
walking distance after only nine weeks of training (twice per week). Mean walking
duration and speed also increased 169% and 9M% respectively. Our participants showed
an average improvement of over one mile of pain free walking!

IT REALLY WORKS!!

Our technique allows you to exercise continuously with very little or no pain.
People look forward to coming to a program that does not hurt them and helps improve
their functional capacity


For more information, please contact Dr. Stopka at (352) 392-05S5 Ext. 259



















APPENDIX B
CLAUDICATION QUESTIONNAIRE




Claudication Questionnaire
.?leas nlace a check ( by thea anronriate answer beowy:

S How many blocks can. you walk on level ground before havir.g to stop?
(1 block-100 yards)

1 block, __ 2 blocks 3 blocks 4 blocks __ no limi=.
or less
2. Z you have cold feec? (For exan-ple, cold to the touch, toes turning
whice, etc.)

never __ seldo __ abouc halt __ mos of __ generally
the time the time always
3. Dc you feel leg or hip pain? (eg, tightness, fatigue, cramping, muscle
Soreness

Yes No If you answered 'No' go co question #6 and corcinue.
4. What are you usually doin when you feel chis pain?

SLying __ sitting __ standing exercising (walking,
climbing stairs, etc.)
5. Please dajcribe and circle chat par= of your leg where you feel the


hip

thigh
Description :thig

C_ alf



lag leg
6. : an experimental exercise treatment program for the leg pain, cold
feet, and restricted walking distance were available, would you want
smcreo.ne to contact you to describe this program? Yes No
t, Do you have diabetes? Yes No_

8. Name Age Phone

Address

Name of physician who cares for you

Thank you! [

















APPENDIX C
MEDICAL HISTORY QUESTIONNAIRE

Name:

Datr__
Fit For Ufe, Inc.
Medical History Questionnare

First, we must decide if it is safe for you to participate i n exercise program. thus we need you to answer a
few questions.

In completing the fiss asessmen there are potendal risks to the client such as abnormal heart beats,
fainting, dizinetss, abnormal blood pressure, figu, muscle soreness, and other which all of the exercise
specialists are aware of. Please feel fre to ask a staff member or your physician if you have any quesdons
regarding these or other pocatial risks. For safety easons, please answer the following quCSboVo to the bes
of your wldge so your fitss assessment is safe and enjoyable.

Please check the appprdiat answer:

Yes No
( ). ( ) 1. Has your physician ever said you have h or cardiovascular disease?
[ ) ( ) 2. Do youever havepain or pressure inyour chet, sblder, or ms?
S) ( ) 3. Do you have umum sloas of breach upon exerdo
( ) ( ) 4. Do youhave a history of dinzzis or fatitg spe
( ) ( ) 5. Has yo physician ever d you have high blood pres~un ?
( ) ( ) 6. Are you 55 years of age or oer?
( ) ( 7. Are youa crrny takingany medical s?
If YES, please list:

( ) ( ) 8. Hav you ever had n exercise sest?
If YES, pclas explain resus__
S) ( ) 9. Hav you a orthopedic condition that may be aggrvated or made worse
by exercise?
If YES, what type of injury/condition occurred and when?



What kind of unate t did you receive? (i.e. srgry, physical therapy, medications)

What sympgom/difflulties ue you stil experiencing due to the injury?

What physieian/P.T. reconmmoded resriecins still remain?

S) ( ) 10, Areyou pregnant If YS, how manymy nhs?
S) ( ) 1. Do you know ofany other physical condition that might be inflnce your ability to
coage in a regular exercise program?












If you answered NO to iuesdions 1-6, you may be a good candidate to ake the fitness asessmem.
However, the fact that you answered NO to all of the above questions is no guaranee th you wi11 not have an
normal response to exercise.
If you answered YES to any of questions 1-6, you may need a physician referral form filled out and
signed by your doctor before participatin in F For Life's fimes assessmeru and exercise program.
This form allows to learn about yur medical history. Please read careflly and answer to bhe best of
your knowledge. ..


Mark (1) in the brackets which apply to your personal history:
( )Anemia
( ) Arthritis In the past 12 mount
( )Asthma ( )Pain or disco
( ) Brochiis ( ) Hean plpiatio
S)Cancer ( ) Uusual shorn
( )Cirrosis ( ) Paininlegswii
( ) Dabees ( ) Poor tolerance
( )Drug dc d ( )Dizzians or f
() Epilepsy ( )Cough on exe
( )Gou ( )Friequcntback
S) Heart disease ( )Swollen, sff o
( )High blood pressure ( ) excessive fati
S)Kidney disease ( ) Prequent head
( )Lung disease ) Broken bones
( ) Nervous/emoional problems ( ) Any other unus
() Overweight
() Phlebitis Do you smoke?
( ) Stroke If YES, bow muc
) Surgery If NO have you ve
S) Thyroid problems If YES,ow longag
[ )Tuberculosis
( ) Ultirs Any orthopedic co
() Other injuries or disabilities


hs have you had any of these symptoms:
ort in ches
ns or flutter
s of breath with exertion
Sexertion
for exercise

Ion
pain
Painful joints
che

ual discomfot?


r day?_

r?
o7?_____
)t>_______


What is your present weigh?
What do you consider a good weight for yourself?

Have any of your close relatives (mother, father, siblings, grandparents) had any of de following? If so, please
indicate th age of the relative when the condition developed.
Siblings Parents Grandparents
S) Heart or cardiovascular disease
( )High blood pressure
( )High cholesterol
( )Diabetes
( )Stroke
I hereby suae that I have answered the above question o ft best of my abiliy.

Signanre:_ Date:

Exercise physiologist:
















APPENDIX D
DEMOGRAPHIC INFORMATION


Monthdday/yver: /

Patient name:_

DOB:

Disability/illness:



Functional level:





Exercise prescription:___









Contraindications:





Emergency information:

Doctor_

Allergies:

Meds:


Contact person:


Phone number:



















APPENDIX E
INFORMED CONSENT


INFORMED CONSENT FORM

To be a oarticiiant in the Secial Phsical Education Proam of Exercise Activities you wi ll ir
need to be referred here by a physician. (The physician referral form is sttndd). We will then formulate
the most ppropriae activity prescription for you related lo safety a well a dressing you moo needed
arms for mprovement such a strength, uenduranc andr flexibility. Activity samples include
treadmill walking stationary cycling stairclimbing. and the use of various weight equipment. Spon and
recrealmial cppcnu itis such a swimming tennis skills, roquet, bowling shufflboard, golf, ad other
activities, to name a few, sometimes available We will do all we can to make any needed adaptations in
equipaCm t or program design to bes meet your individual needs.

This special physical education prup~m of aciviies is rousing and medically approved a nd
prescribed by your physician. No discomforts or risks are expected. You are rom being kep from
receiving any allrnative procedures. The expected bencfils include a noticeable increase in your walking
ability, overall physical fitness levels. skill performances Irvls, ani/ur feelings of well being and
confidence. The approximtle duration of your paicipation is one to so masters.

If information is rporterd from Itis study. your nane will not be used (in order to project your
privacy). The reach may be in the form of small group studies or sing study ase analyses. The
purpose of this research is In learn and report ac ivities undertaken that are especially beneficial to
participant with various temporary or permanently disabling condition. We will use this information to
improve the our program srvics to you and oll t in the future.

If you have any queuio s as any lime, please fo free to mak,* You may feel fra to participate in
the program as lkng as you and your physician would like you lo. You are free to withdraw yor consent
for participation atny lime without any prejudice by any of he stalT. Thcr is no compensation. If you
have any qstions or concerns about your rights as a research pantiipant you may contact the University
of Florida Intitutioml Review board (UIIRB) office at 98A Psychoogy Building. Box 112250,
Univeity oflorida, Gainesville, FL 32611-225(; phonf ax: (352)392-0433 (c-mail is IRB2@ufl-edu).
If you are ijured during this study, as a result of the negligence of he principal investigator, the
University of Florida, the Board of Regents of the State of Flo rda aid the State of Florida shall be liable
only as provided by aw. You should infurni the principal investigator of this incident, thte you iny seek
appropriate comnpemation for the injury by con0tacing ihe Insurance Coordinrm r ul 316 Sadium. UF,
(352) 392-2556.

I have read the procedure described above. I volunarily agree to pan icipate in ihis program and I
have received a copy of this description.


Perticiparu Date Winess Dte


Relatiomhip if other Date Principal invesigator's Date
than participant name


*Christine Stopk. P.D., ATC/L, CSCS, CAPE, MTAA
Professor Box 118210
5A Ficrida Gym; University of Floida
Gainesville FL 32611 (352) 392-0583, ext 1259


Approved By
University O Florida
I)stitutonal Revew Board 02
For Use hrouh 125201- I 20


















APPENDIX F
THERAPEUTIC STRETCHES


Calf Srch
Plce your hands on the wall and step back with the leg to be strncied.
Start by playing only the ball of th oot oa he ground and by
keping the knee sraiga
Push tho heel of thes Trething leg down to the yound, keeping the toes
and foot poindag directly forward unil you feel the metchin
bak oftheleg. Hold 10 cuina
Couramt the muclde by pushing your utoe and the baUl of yot bot into
the groud withwo lifting the bheL Hold 5 caus .
Relax the comtratad, hold the leg in the sane position, ad slide the foo
funter behind you I order to gain more surchb. Hold 10 count

Sit and Reach (Ham rings and Lower Back Stretch)
Sit o the flrorou o ground gan front of= yaog nbyb and
with the kn flat on the ground.
Bead forward and gasp the underside of your ankles or shis.and pull
yourself att mpdin to touch yor nose to yur kees. You will
feel the tch i thloamr hackand inzthm.alnfthbehigh
Conrawt t musl des by trying to lean ba k with your hads preveng
you from moving. Hold 5 cimun
Relax and pull yourselfdown u fiher imo the mrtch. Hold 10 county

Buttrfly (Groin) Strach
Sit o the floorr ground with the les ofyour fes together. Grasp
your ankles. pull yourleels toward yyowand-placs your lbows
on your knees.
Use yur bows to push your knecs down toward the floor unil you
fel ties treth in the inner ligh Hold 10 counts
Contraf the musdes by pushing your nees into your ebow without
latlng the kses com claer together. Hold 5 cnu.
Relax and push the Ik s after toward the floor. Hold 10 counts.

Knee to Cheat (GlutsdL Streth
Lie flat n your bac. Bend one knee and pull you leg toward you chest.
Grasp the bank t thi thigh hands hetsweayour.ttighksdaljf nd
pull th leg closerto your chet umil you ftel the istech in the
buttocks. Hold 10 clO as.
Contrac the mucles by trying to mve your leg away fom your chest
but with your handamsupvting any movement Hold S.couns
Relax and pull your g closer to yor che. Hold 10 cou=s.

Quadriceps Strtch
Place one hand on a wall and stand only an tbe opposite leg.
Bend the other ke and grap ths ankld with the fwhbal.
Bend the fknee father bak attempting totoouch the beel to the blocks.
Try to bold the leg so she hlghlanmgs sihrdm wumnrd the
floor and do notlean forward. Hold O1 out,
Conutrt the macle by Uying-m sgaign th e Im with thn hands
prevnting any movement Hold s eouto.
Relax andpu ll youwr hetl cnar yaut rbaino.o.alddlO ian'L


-,:


'7-i












Chest Stretch
Stand arm'slgth away from the wall,
Raise one arm sraigti out so that your hand is fat ain$t the wall,
Turn your body away from the wall until you feel a stretch in your
chest. Be suzi artrthre natchlsotslte &aArioar feam .
Hold 10 counts
Contra tbe musc by pressing imo the wall ba dAnj leI your body
twist back toward the wall. Hold 5 county.
ReLax and stretch rather by twisting away omthe wall. Hold 10 comus.

Rear Deltoid Stretch
Raise one arm in front of you and nrch for th opposite shoulder
With your otber a, grasp just behind the elbow of t first arm.
Pull ho arm further aoss your body ri youwel a stretch in the
back of the shoulder. Hold 10 conts.
ConMat The uscle by pushing your elbow ino yor hand as if you
were moving the arm back to its nralnpositin Hold 5 cots.
Relax ad pull your elbow firthr inm the srach Hold 10 com=&

Triceps Stwchb
Raise one arm sraig over your head
Bend the elbow of the raised arm so your hand fat behind your head.
With your other arm. rap your elbow and pull the ar closer to your
bead. Hold 10 county.
Contract the muscldby pushing your elbow into your and is if you
were bringoig the elbow away fom the ha. Hold 5 coums.
Relax =ad pull your elbow fErther ino thebsch. Hold 10 couns.

Erternal Rotator Cuff Stretch
PlAc the back of your had fl against the midd-lower pation of
your ibak
Reah s high up your back as possible
To assist you in stching hold a towde with both bands so that the
towd is behind tie opposite shoulder. Pull th towel up and
across your back so that you fed trtch in the fro of yor
shaolder, Hold 10 counts.
Contract the oascle by prcssaih dhe badc of your hand ino your back
Hold 5 comts.
Relax and brig your hand higher acos your back. Hold 0 couns.

Internal itaa CuffSttekh
Suand in a doorway or rad to a srianary object.
Bead your elbow so tha your hand is flat mtainstthe objec: / walM and
keep your ebow at your side
Turn your body away fom the wal/lobject umil your fet a stretch in
the font of your shoulder. Hold 10 u.
Cooract the muscle by prisigywour hand iotie wall buzt deng kt
your body isrbhak toward ho object I wall Hold $ co=ts.
Relax and sttcbh futber by twisting away from ewani again.
Hold 10 courts.


K-]


,---










APPENDIX G
EXERCISE TRAINING LOG













21
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q^ q E ii~i
IL A ____ |i
I ; ----------------- III




__ I 111
F~~~1 -.'i- s

jS is i I
a S i IZ fii iI~



S-- i
mn &
;ll















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BIOGRAPHICAL SKETCH

Ms. Coleen Archer, born and raised in West Virginia, is currently completing the

requirements for a Master of Science degree in the College of Health and Human

Performance at the University of Florida. Ms. Archer specialized in adapted physical

activity.

Ms. Archer received her bachelor's degree in exercise and sport sciences from

the College of Health and Human Performance at the University of Florida in May 2003.

She specialized in exercise physiology.

Ms. Archer is a Master Teacher of Adapted Aquatics (MTAA) and a Certified

Strength and Conditioning Specialist (CSCS). She plans to continue her education to

pursue a career in adapted physical activity.