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

This study is currently recruiting participants.
Verified February 2013 by University of South Carolina
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01377064
First received: June 8, 2011
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Cardiovascular Diseases
Hyperlipidemia
Obesity
 Behavioral: Physical Activity Group
Other: Standard Care Group
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home-based Exercise for Management of HIV-associated Cardiovascular Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377064

Contacts
Contact: Gregory A Hand, PhD 803-777-3908 ghand@sc.edu

Locations
United States, South Carolina
The Citadel Recruiting
Charleston, South Carolina, United States, 29425
Contact: Wesley D Dudgeon, PhD     843-953-6307     dudgeonw1@citadel.edu    
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208
Contact: Gregory A Hand, PhD     803-777-3908     ghand@sc.edu    
Sponsors and Collaborators
University of South Carolina
National Institute of Nursing Research (NINR)
  More Information

No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01377064     History of Changes
Other Study ID Numbers: 1R21NR011281, 1R21NR011281
Study First Received: June 8, 2011
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
HIV
physical activity
cardiovascular disease risk

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Obesity
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013