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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Obesity; Hyperlipidemia
• Intervention / Treatment: Behavioral: Physical Activity Group; Other: Standard Care Group

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • The Citadel
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Institute of Nursing Research (NINR)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (Estimate): June 20, 2011

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; HIV; cardiovascular disease risk
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Cardiovascular Diseases; Hyperlipidemias
• Other Study ID Numbers: Pro00007339; 1R21NR011281 (U.S. NIH Grant/Contract)