Effectiveness of a Group-Based Aerobic Exercise Intervention in HIV+ Patients: A Pilot Study A DISSERTATION SUBMITTED TO THE GRADUATE DIVISION OF THE UNIVERSITY OF HAWAI‘I AT MĀNOA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY IN EDUCATION December, 2012 By Rachel A. Lindsey Dissertation Committee: Iris F. Kimura, Chairperson Ronald K. Hetzler Christopher D. Stickley Cecilia M. Shikuma Dominic C. Chow ACKNOWLEDGMENTS First and foremost I have to thank my advisor, Iris Kimura, for getting me to this point. I am sure it would have not been possible without the support and guidance she showed me throughout this process. No words can fully express how grateful I am. I am also thankful for all the help that was given to me by my committee members, Dr. Stickley, Dr. Hetzler, Dr. Shikuma and Dr. Chow. It was my pleasure to go through this process with such amazing classmates. Thank you Rachele Vogelpohl and Kaori Tamura for your support and encouragement. I am extremely grateful for my parents and family for supporting the choices I have made, even if they took me 6,000 miles away from home. They have always encouraged me to follow my dreams and made me feel that I could accomplish any goal. Finally, I have to thank my best friend and partner, Michelle Swan, for believing in me and encouraging me to always be the best version of myself.   2 ABSTRACT Background: Exercise is recommended for HIV+ patients to control their disease as well as HAART side effects. Unfortunately, only 25 to 28.2% of HIV+ individuals engage in moderate physical activity and drop-out rates range from 45 to 87% in HIV+ cohorts. Group exercise has been shown to improve compliance. Therefore, the purpose of this study was to evaluate the effectiveness of a group-based aerobic exercise program in HIV+ individuals. Methods: A pretest-posttest design was used to evaluate the effects of a 12 wk group- based aerobic exercise program on fitness level, lipid levels, insulin sensitivity, body composition, and quality of life in HIV+ individuals. Participants were 18 sedentary HIV+ males between 32 and 59 years of age (mean 45 ± 6.34) on HAART. Results: Eighteen participants were enrolled; nine completed the exercise program and six of the nine were considered compliant, attending >70% of the exercise sessions. Improvements (P=0.03) in triglyceride level and health transition scores (quality of life dimension) (P=0.02) were seen post intervention. Improvements in VO (P = 0.03) 2max were revealed among the six compliant participants. Self-efficacy for exercise and group cohesion were measured pre and post intervention, and provided descriptive information. Self-efficacy scores were lower for those who withdrew (53.66± 3.49) compared to those who completed the exercise intervention (64.22±17). Participants who were compliant (52.33±6.10) demonstrated more cohesiveness than those who were not (71.34 ±9.4). Conclusion: Those who completed the program displayed lower triglyceride levels and felt better about their overall physical health and emotional condition at the conclusion of   3 the exercise program. Participants who withdrew were less confident that they could overcome barriers to exercise than those who completed the study. Not surprisingly, compliant participants felt more united as a group. Within the limitations of this study, a 12 wk group-based aerobic exercise program resulted in improvements in cardiorespiratory fitness. Additionally, no negative effects on immune function in HAART treated HIV+ individuals were found further supporting group-based aerobic exercise programs are a viable adjunct treatment option.   4 TABLE OF CONTENTS Abstract …………………………………………….……………………………………..3 List of Tables and Figures………………………..………………………………………..7 Part I Introduction…………..…………………………………………………………....8 Methods ………………………………………………………………………….10 Results …………………………………………………………………….……..15 Discussion …………………………………………………………………….…19 Part II Review of Literature……………………………………………………………..24 Metabolic Disorders Associated with HIV and HAART..........................24 Manifestation of Metabolic Disorders in Exercise ...................................28 Exercise Mediation ...................................................................................31 Exercise Prescription ................................................................................37 Design of Exercise Clinical Trial..............................................................41 References……………………………………………………………………………….53 APPENDICES A. Informed Consent Form ……………..………………………………………….…...58 B. American College of Sports Medicine’s Contraindications to Exercise..…….….…..71 C. American College of Sports Medicine’s Termination of Exercise Guidelines ..….…72 D. Physical Activity Readiness Questionnaire ………………………………………….73 E. Emergency Action Plan, Leahi Hospital……………………………………….…….77 F. Emergency Action Plan, Ala Moana Park……………………………………………78   5 G. Screening Sheet………………………………………………………………………79 H. Self-Efficacy for Exercise Scale……………………………………………………..81 I. Maximal Exercise Testing Data Collection Sheet………………………………….…82 J. Medical Outcomes Study HIV Health Survey………….……………………..………83 K. Physical Activity Group Environment Questionnaire……………………………….90 L. Exercise Instructor Questionnaire……………………………………………………92 M. Ratings of Perceived Exertion Scale…………………………………………………93 N. Exercise Session Data Collection Sheet……………………………………………..94   6 LIST OF TABLES and FIGURES Table 1: Demographic, Physical, Clinical Characteristics, Quality of Life (MOS-HIV) and Self-Efficacy for Completers and Non-Completers at Entry (n=18) ……..……….16 Table 2: Exercise Prescription Data for Completers (n=9) ……………….………..…..17 Table 3: Demographic, Physical, and Clinical Characteristics for Completers (n=9) at Entry and 12 wks…………………...………………………………………………….………………17 Table 4: Quality of Life (MOS-HIV) Data for Completers at Entry and 12 wks….......17 Table 5: Physical Activity Group Environment Questionnaire at 12 wks for Compliers (n=6) and Non-Compliers (n=3) ………….………………………………….………….18 Figure 1: Health Related Quality of Life (MOS-HIV) Comparison at Entry…..………21   7 Part I INTRODUCTION Highly Active Antiretroviral Therapy (HAART) minimizes Human Immunodeficiency Virus (HIV) replication and improves immune function, which has reduced mortality rates and extended life expectancy [1]. Though HAART significantly enhances the management and clinical outcome of HIV with increased survival rates, these favorable effects are limited by the development of metabolic disorders including dyslipidemia, increased central adiposity, and insulin resistance [2, 3].   Metabolic syndrome is a combination of the aforementioned disorders and results in a potential increased risk for cardiovascular disease and diabetes [4, 5]. Even after adjustment for age, sex, cholesterol level, physical activity, and smoking, metabolic syndrome was found to double coronary heart disease mortality in HIV+ individuals [3] and has been associated with a five to eight fold increased diabetes prevalence [4]. Exercise training and physical activity are well-known to have positive effects on risk factors associated with metabolic syndrome including central adiposity, very low- density lipoproteins (VLDL), low-density lipoproteins (LDL), triglycerides, and high- density lipoproteins (HDL) in people who are HIV-negative [6, 7]. Exercise improves cardiorespiratory fitness in HIV+ individuals [8-11], however, results are variable regarding hypertension, hyperlipidemia, diabetes mellitus, and visceral fat mass [8-13]. Despite this variation, exercise has proved to have a positive effect on metabolic   8 parameters in HIV+ patients [9, 14]. Therefore, exercise prescription is a viable alternative to additional drug therapy [13]. Regular exercise is recommended for HIV+ patients to control their disease as well as pharmacological side effects [15]. Despite this recommendation, only 25 [16] to 28.2% of HIV+ individuals engage in moderate physical activity according to Healthy People 2010 guidelines [17]. Even after initiation of an exercise program, drop-out rates are problematic ranging from 45 to 87% in HIV+ cohorts [10, 12, 18-20]. The majority of adult participants prefer to exercise with others rather than alone, [21-23] as group exercise adds psychological and social support [19]. Consequently, compliance in group- based programs exceeds individually based programs [19, 20]. Therefore, the purpose of this study was to evaluate the effects of a group- based aerobic exercise program on fitness level, lipid levels, insulin sensitivity, body composition, and quality of life (MOS-HIV) in HIV+ individuals.   9 METHOD Research Design A pretest-posttest design was used to evaluate the effectiveness of a 12 wk group- based aerobic exercise program for HIV+ individuals. The independent variable was test (pre, post) and dependent variables included: fitness level, lipid levels, insulin sensitivity, body composition, and quality of life (MOS-HIV). Participants Participants were 18 HIV+ males between 32 and 59 years of age (mean 45 ± 6.34). Inclusionary criteria consisted of: a stable HAART regimen defined as no change in medications six months prior to the study; and no regular aerobic conditioning in the previous three months. Regular aerobic conditioning was defined as performing more than 30 minutes of an aerobic activity at an intensity of five metabolic equivalents [24] and more than two days per week. Exclusionary criteria consisted of: Acquired Immune Deficiency (AIDs); neurological defects (i.e. dementia, neurological disease, multiple sclerosis, brain tumor, and Parkinson’s disease); absolute contraindications to exercise as outlined by the American College of Sports Medicine [25] (APPENDIX B); or any condition in the opinion of the investigators that would interfere with the study. Informed consent forms, (APPENDIX A) approved by the University Institutional Review Board, Human Studies Program were signed by all participants prior to the study.   10