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| Sponsor: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00627380 |
Purpose
We are testing the safety and efficacy of a 16-wk yoga lifestyle intervention on oral glucose tolerance, fasting lipid/lipoprotein levels, body composition, cardiovascular function, quality of life, CD4+ T-cell counts and viral load in HIV-infected men and women with components of The Metabolic Syndrome. We hypothesize that a yoga lifestyle intervention will improve metabolic, anthropometric, cardiovascular disease parameters, and quality of life domains without adversely affecting immune or virologic status in people living with HIV.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections HIV Metabolic Cardiovascular Syndrome HIV Lipodystrophy HIV Metabolic Syndromes Hypertension |
Behavioral: Yoga lifestyle intervention Other: Standard of care |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Yoga for the Management of HIV-Metabolic Syndromes |
| Enrollment: | 50 |
| Study Start Date: | November 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
STOC: Placebo Comparator
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
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Other: Standard of care
Participants are observed/followed for 16 weeks during which lifestyle and medication changes are discouraged, unless medically necessary.
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YOGA: Experimental
Yoga lifestyle intervention administered by certified yoga instructor.
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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.
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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:
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Additional Inclusion Criteria.
"Normal" blood chemistries for at least 1 month prior to enrollment:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Washington University ( Kevin E. Yarasheski/Principal Investigator ) |
| Study ID Numbers: | R21 AT003083, WU187 |
| Study First Received: | February 28, 2008 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00627380 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV AIDS insulin resistance diabetes dyslipidemia visceral adiposity |
subcutaneous adipose wasting cardiovascular disease hypertension endothelial function quality of life Complementary Therapies |
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Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Hyperinsulinism Pathologic Processes Syndrome Lipodystrophy Cardiovascular Diseases Retroviridae Infections RNA Virus Infections Metabolic Syndrome X Metabolic Diseases Disease Immune System Diseases |
Skin Diseases Acquired Immunodeficiency Syndrome Vascular Diseases Immunologic Deficiency Syndromes Virus Diseases HIV Infections Skin Diseases, Metabolic Sexually Transmitted Diseases Lentivirus Infections Insulin Resistance Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders |