Home-based Exercise for Management of HIV-associated Cardiovascular Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of South Carolina
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Amount of Physical Activity
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Physical activity group
Subjects will participant in physical activity program
Intervention: Physical Activity Group (Behavioral)
Standard care group
This group will not receive a physical activity intervention
Intervention: Standard Care Group (Other)
Outcomes
Primary Outcomes
Amount of Physical Activity
Time Frame: 9 months
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.
Secondary Outcomes
- Cardiorespiratory Fitness(9 months)