Clinical trial NCT01377064: Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk
Official title: Home-based Exercise for Management of HIV-associated Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Hyperlipidemia
Obesity
Keywords: HIV
physical activity
cardiovascular disease risk
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Amount of Physical Activity
timeFrame: 9 months
Secondary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: 9 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: The Citadel
state: South Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.