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

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University of South Carolina

Status and phase

Completed
Phase 1

Conditions

Hyperlipidemia
Obesity
Cardiovascular Diseases

Treatments

Behavioral: Physical Activity Group
Other: Standard Care Group

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01377064
Pro00007339
1R21NR011281 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Physical activity group
Experimental group
Description:
Subjects will participant in physical activity program
Treatment:
Behavioral: Physical Activity Group
Standard care group
Active Comparator group
Description:
This group will not receive a physical activity intervention
Treatment:
Other: Standard Care Group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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