A home-based exercise intervention to increase physical activity among people living with HIV: study design of a randomized clinical trial

BACKGROUND: While combination antiretroviral therapy has extended the life expectancy of those infected with human immunodeficiency virus (HIV), there is a high prevalence of comorbidities that increase the risk of cardiovascular morbidity and mortality among people living with HIV/AIDS (PLWHA). The side effects associated with antiretroviral therapy (ART) lead to multiple metabolic disorders, making the management of these metabolic issues and risk of cardiovascular disease (CVD) in those treated with ART a critical issue. Clinical research trials, primarily clinical exercise, rarely include this population due to unique challenges in research methods with underserved minority populations living with a life threatening illness like HIV/AIDS. This paper describes the rationale and design of a randomized clinical trial evaluating the feasibility of a home-based exercise program designed to increase physical activity (PA) and reduce the risk of CVD in PLWHA. METHODS/DESIGN: PLWHA being treated with ART will be randomly assigned to one of two groups: a home-based PA intervention or standard care. All participants will receive an educational weight loss workbook and pedometer for self-monitoring of PA. Only those in the intervention group will receive additional elastic Thera-bands® for strength training and behavioral telephone based coaching. DISCUSSION: This study will evaluate the feasibility of a home-based program designed to increase PA among PLWHA. Further, it will evaluate the effectiveness of such a program to decrease modifiable risk factors for CVD as a secondary outcome. This study was funded by the NIH/NINR R21 Grant 1R21NRO11281. TRIAL REGISTRATION: Clinical Trial Identifier NCT01377064