Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk

Study Overview
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Brief Summary
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Because of advances in drug treatment, people living with HIV/AIDS (PLWHA) are living longer, but are also at greater risk for cardiovascular disease (CVD) and diabetes. Exercise and increased physical activity can reduce the risk factors for these diseases in PLWHA, but no studies have tested an at-home exercise program that would benefit low income people and others who do not have access to exercise facilities. This study will test the feasibility of an at-home exercise program for PLWHA and prepare for a full-scale intervention study, which may lead to a reduction in CVD risk among PLWHA.

Official Title
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Home-based Exercise for Management of HIV-associated Cardiovascular Disease

Conditions
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Cardiovascular Diseases, Hyperlipidemia, Obesity

Intervention / Treatment
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* Behavioral: Physical Activity Group
* Other: Standard Care Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Medical diagnosis of HIV-1 positive serostatus Sedentary lifestyle: not actively exercising ≥ 3 d•wk-1 for 20 min per session 18.5 kg/m2 < BMI < 40.0 kg/m2 Stable, DHHS-approved ART regimen for previous 3 months, with HIV viral load below 75 copies/mL Capable of performing the required exercise regimen Have daily access to a telephone for approximately 10 months Capacity and willingness to provide informed consent and accept randomized group assignment Exclusion Criteria: Individuals who have a clinical history strongly suggestive of Type 1 diabetes. History of serious arrythmias, cardiomyopathy, congestive heart failure, stroke or transient ischemic cerebral attacks, peripheral vascular disease with intermittent claudication, myocardial infarction, or CABG. Malignancies in the past 5 years, except therapeutically controlled skin cancer. Plans to be away > 4 weeks in the next 9 months Score of 5 or greater on the DAST or MAST (signifying excessive use of drugs or alcohol). Weight loss in excess of 10% body weight in previous 12 weeks. Chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions. Inflammatory-related conditions such as collagen disorders. Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity group<br>Subjects will participant in physical activity program | Behavioral: Physical Activity Group<br>* 9 months of home based physical activity meeting HHS recommendations for physical activity for all americans<br>|
| Active Comparator: Standard care group<br>This group will not receive a physical activity intervention | Other: Standard Care Group<br>* No intervention, the group will be followed under their standard medical care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Physical Activity | Accelerometer data will be the primary means of determining the participants' physical activity levels. Participants will be instructed to wear the accelerometer at baseline, 4 months, and 9 months. The participants will be required to wear the accelerometer during the waking hours for seven consecutive days. Data from participants with at least four days and at least 10 hours per day will be included. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory Fitness | Each participant will complete a graded exercise stress test (GXT) with indirect calorimetry. This test will be used to screen for abnormal physiological responses to exercise and for determining the participant's maximal ability to utilize oxygen (an index of cardiorespiratory fitness). | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, physical activity, cardiovascular disease risk