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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01377064
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : December 12, 2013
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Hyperlipidemia Obesity Behavioral: Physical Activity Group Other: Standard Care Group Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home-based Exercise for Management of HIV-associated Cardiovascular Disease
Study Start Date : March 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Physical activity group
Subjects will participant in physical activity program
Behavioral: Physical Activity Group
9 months of home based physical activity meeting HHS recommendations for physical activity for all americans

Active Comparator: Standard care group
This group will not receive a physical activity intervention
Other: Standard Care Group
No intervention, the group will be followed under their standard medical care.

Primary Outcome Measures :
  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 Outcome Measures :
  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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01377064

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United States, South Carolina
The Citadel
Charleston, South Carolina, United States, 29425
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
National Institute of Nursing Research (NINR)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of South Carolina Identifier: NCT01377064    
Other Study ID Numbers: 1R21NR011281 ( U.S. NIH Grant/Contract )
1R21NR011281 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Keywords provided by University of South Carolina:
physical activity
cardiovascular disease risk
Additional relevant MeSH terms:
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Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases