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Practicing Restorative Yoga or Stretching for the Metabolic Syndrome (PRYSMS)

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ClinicalTrials.gov Identifier: NCT01024816
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : June 26, 2014
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
The purpose of this study is to determine whether Restorative yoga versus stretching exercises will reduce risk factors for metabolic syndrome in adults with metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Restorative yoga Behavioral: Stretching Not Applicable

Detailed Description:

Metabolic abnormalities, including visceral adiposity, insulin resistance, hyperglycemia, hypertension and dyslipidemia, occur together and are associated with excessive caloric intake and inadequate physical activity. Persons with the metabolic syndrome are at high risk of developing type 2 diabetes and cardiovascular disease. Lifestyle and behavioral interventions reduce these risks, but many individuals with increased metabolic risk find it difficult to achieve and maintain weight loss and increased physical activity.

We are conducting a rigorous randomized controlled trial at two clinical sites to determine if Restorative yoga compared to stretching exercises improves the metabolic syndrome among overweight and underactive individuals who meet criteria for the metabolic syndrome.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Practicing Restorative Yoga or Stretching for the Metabolic Syndrome
Study Start Date : December 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Restorative yoga intervention Behavioral: Restorative yoga

Group yoga sessions: Participants will attend 90 minute yoga group classes for 48 weeks: twice a week for 6 weeks, then once weekly during weeks 7 to 12, then every other week for weeks 13 - 24, and once a month for 6 months. We plan a progressive series of classes, with a subset of poses for each class and then selecting individual poses to focus on in each class.

Home yoga practice: Participants will be given a video disk (DVD) of the yoga postures at the start of the yoga intervention practice. We will also provide the yoga participants with a written manual with pictures and descriptions of each posture that they will be taught in the group sessions. The participants will be asked to practice the postures taught during their group sessions at home at least three times a week with the assistance of the DVD and manual. Each participant will be given a set of yoga props for their use at home. We will ask all participants to keep a log of their home practice sessions
Active Comparator: Stretching group Behavioral: Stretching

Group classes: Participants will attend 90 minute group stretching classes for 48 weeks: twice a week for 6 weeks, then once weekly during weeks 7 to 12, then every other week for weeks 13 - 24, and once a month for 6 months. The stretches will address all body parts, including cervical, upper extremity, thoracic, lumbar, pelvic, and lower extremity musculature.

Home stretching practice: Each participant will receive a written manual with pictures and descriptions of each stretch that they will be learning in group sessions and a DVD with instruction on each of the stretches. The participants will be asked to practice the stretches taught during their group sessions at home at least three times a week with the assistance of the DVD and manual. Each participant will be given stretching supplies. We will ask all participants to keep a log of their home practice sessions.


Outcome Measures
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Primary Outcome Measures :
  1. visceral adiposity by abdominal CT scan [ Time Frame: 6-months and 12-months ]

Secondary Outcome Measures :
  1. systolic blood pressure, fasting triglycerides, and fasting insulin levels (co-primary outcomes); change in glucose tolerance, HbA1c levels, high density lipoprotein (HDL) cholesterol, and quality of life (secondary outcomes). [ Time Frame: 6-months and 12-months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anyone between the ages of 21 and 65 who may meet the criteria for the metabolic syndrome can sign-up for the screening process. A more thorough screening process will be conducted to determine whether or not you are eligible to enroll in the study
  • Underactive
  • Overweight

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Chronic illnesses: cancer, kidney disease, cirrhosis of the liver, rheumatologic diseases, or chronic infections
  • Not ambulatory or neurological condition causing impaired mobility
  • Weight over 400 pounds
  • History of or plans for bariatric surgery
  • Inability to speak and read English
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01024816


Locations
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United States, California
University of California, San Diego
San Diego, California, United States, 92037
Unversity of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
University of California, San Diego
Investigators
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Principal Investigator: Alka Kanaya, MD University of California, San Francisco
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01024816    
Other Study ID Numbers: 1R01AT004569-01A2 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Keywords provided by University of California, San Francisco:
Metabolic Syndrome
Restorative Yoga
Stretching
Visceral adiposity
Randomized controlled trial
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases