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Completed

NCT Number: NCT01377064

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

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Body Weight Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Citadel, Charleston, South Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity group

Behavioral

9 months of home based physical activity meeting HHS recommendations for physical activity for all americans

Standard Care Group

Other

No intervention, the group will be followed under their standard medical care.

Primary outcomes

  1. 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

  1. Cardiorespiratory Fitness

    Time frame: 9 months

    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).

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 20, 2011
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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