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

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:

MedlinePlus related topics: Exercise and Physical Fitness HIV/AIDS Health Checkup

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 ]
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 ]
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).


Enrollment:	60
Study Start Date:	March 2011
Study Completion Date:	July 2013
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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

University of South Carolina

National Institute of Nursing Research (NINR)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	University of South Carolina
ClinicalTrials.gov Identifier:	NCT01377064 History of Changes
Other Study ID Numbers:	1R21NR011281 ( U.S. NIH Grant/Contract )
Study First Received:	June 8, 2011
Last Updated:	December 10, 2013

Keywords provided by University of South Carolina:


HIV physical activity cardiovascular disease risk

Additional relevant MeSH terms:


Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on July 17, 2017