Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk
Completed · Phase 1
Conditions studied: Cardiovascular Diseases, Hyperlipidemia, Obesity
In brief
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.
Key facts
- Study ID
- NCT01377064
- Run by
- University of South Carolina
- People needed
- 60
- Starts
- 2011-03-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2021-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Citadel — Charleston, South Carolina, United States
- University of South Carolina — Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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