Yoga for the Management of HIV-Metabolic Syndromes
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|