Yoga for the Management of HIV-Metabolic Syndromes
|ClinicalTrials.gov Identifier: NCT00627380|
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : July 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections HIV Metabolic Cardiovascular Syndrome HIV Lipodystrophy HIV Metabolic Syndromes Hypertension||Behavioral: Yoga lifestyle intervention Other: Standard of care||Phase 4|
Very few safe, effective, and novel treatments for metabolic syndromes that develop in HIV-infected people exist. These metabolic syndromes may increase cardiovascular disease risk in HIV-infected people and may reduce their quantity and quality of life. Practicing a yoga lifestyle intervention may provide a safe, effective and novel therapy for HIV metabolic syndromes, but this alternative form of therapy has not been tested in HIV-infected people with metabolic syndromes. In men and women with HIV-related metabolic syndromes, we will determine:
- The safety of practicing a yoga lifestyle in HIV-infected people treated with HAART who are experiencing metabolic and anthropometric syndromes.
- To quantify the effects of practicing a yoga lifestyle on metabolic and anthropomorphic syndromes in HIV-infected people treated with HAART who are experiencing these syndromes.
- To quantify the effects of practicing a yoga lifestyle on cardiovascular disease (CVD) risk in HIV-infected people treated with HAART who are at increased CVD risk because of existing metabolic and anthropomorphic syndromes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Yoga for the Management of HIV-Metabolic Syndromes|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Placebo Comparator: STOC
Standard of care arm continues to receive standard of care treatment for HIV, but does not receive any new treatment/intervention or change in anti-HIV medications. Runs parallel to experimental group. At the end of this 16-wk control period, participants are invited to crossover into the experimental group
Other: Standard of care
Participants are observed/followed for 16 weeks during which lifestyle and medication changes are discouraged, unless medically necessary.
Other Name: Observation control group
Yoga lifestyle intervention administered by certified yoga instructor.
Behavioral: Yoga lifestyle intervention
Sixteen weeks of 2-3 yoga sessions per week, 1.5 hrs per session administered by a certified yoga instructor. Sessions include breathing exercises and yoga postures/positions.
- The primary efficacy outcome is a metabolic parameter: insulin integrated area under the curve (AUC) during the oral glucose tolerance test. [ Time Frame: Baseline and week 16 ]
- Fasting lipid/lipoprotein levels. [ Time Frame: Baseline and week 16 ]
- Body composition: visceral and subcutaneous adipose tissue areas (VAT, SAT), trunk/limb adipose ratio. [ Time Frame: Baseline and week 16 ]
- Cardiovascular disease risk: Framingham 10-yr CVD risk calculation [ Time Frame: Baseline and week 16 ]
- Quality of life: SF36 MOS [ Time Frame: Baseline and week 16 ]
- Safety: CD4 count and plasma HIV RNA [ Time Frame: Baseline and week 16 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627380
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Kevin E Yarasheski, PhD||Washington University School of Medicine|