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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01377064
First received: June 8, 2011
Last updated: December 10, 2013
Last verified: December 2013

June 8, 2011
December 10, 2013
March 2011
July 2013   (final data collection date for primary outcome measure)
Amount of Physical Activity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01377064 on ClinicalTrials.gov Archive Site
Cardiorespiratory Fitness [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk
Home-based Exercise for Management of HIV-associated Cardiovascular Disease

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cardiovascular Diseases
  • Hyperlipidemia
  • Obesity
  • Behavioral: Physical Activity Group
    9 months of home based physical activity meeting HHS recommendations for physical activity for all americans
  • Other: Standard Care Group
    No intervention, the group will be followed under their standard medical care.
  • Experimental: Physical activity group
    Subjects will participant in physical activity program
    Intervention: Behavioral: Physical Activity Group
  • Active Comparator: Standard care group
    This group will not receive a physical activity intervention
    Intervention: Other: Standard Care Group
Jaggers JR, Dudgeon W, Blair SN, Sui X, Burgess S, Wilcox S, Hand GA. A home-based exercise intervention to increase physical activity among people living with HIV: study design of a randomized clinical trial. BMC Public Health. 2013 May 24;13:502. doi: 10.1186/1471-2458-13-502.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01377064
1R21NR011281, 1R21NR011281
Yes
University of South Carolina
University of South Carolina
National Institute of Nursing Research (NINR)
Not Provided
University of South Carolina
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP