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| Sponsor: | Washington University School of Medicine |
|---|---|
| Collaborator: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | Washington University School of Medicine |
| 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: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Yoga for the Management of HIV-Metabolic Syndromes |
| Enrollment: | 60 |
| 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
|
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.
|
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, R21AT003083, WU187 |
| Study First Received: | February 28, 2008 |
| Last Updated: | December 17, 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 |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Metabolic Diseases Slow Virus Diseases Metabolic Syndrome X Skin Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Vascular Diseases Immunologic Deficiency Syndromes Virus Diseases Hyperinsulinism |
Skin Diseases, Metabolic HIV Infections Lipodystrophy Sexually Transmitted Diseases Lentivirus Infections Cardiovascular Diseases Insulin Resistance Glucose Metabolism Disorders Retroviridae Infections Lipid Metabolism Disorders Hypertension |