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

Sponsor

University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT01377064

Collaborator

National Institute of Nursing Research (NINR) (NIH)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Mar 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Amount of Physical Activity [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

Cardiorespiratory Fitness [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Citadel	Charleston	South Carolina	United States	29425
2	University of South Carolina	Columbia	South Carolina	United States	29208

Sponsors and Collaborators

University of South Carolina
National Institute of Nursing Research (NINR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of South Carolina

ClinicalTrials.gov Identifier:

NCT01377064

Other Study ID Numbers:

Pro00007339
1R21NR011281

First Posted:

Jun 20, 2011

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Keywords provided by University of South Carolina

HIV

physical activity

cardiovascular disease risk

Additional relevant MeSH terms:

Cardiovascular Diseases

Hyperlipidemias

Study Results

No Results Posted as of Apr 28, 2021