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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377064
• Other study ID #: Pro00007339
• Secondary ID: 1R21NR011281
• Status: Completed
• Phase: Phase 1
• Start date: March 2011
• Est. completion date: July 2013

Study information

• Verified date: April 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipidemia
• Hyperlipidemias
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	The Citadel	Charleston	South Carolina
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Physical Activity	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.	9 months
Secondary	Cardiorespiratory Fitness	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).	9 months