Practicing Restorative Yoga or Stretching for the Metabolic Syndrome (PRYSMS)
|ClinicalTrials.gov Identifier: NCT01024816|
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : June 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: Restorative yoga Behavioral: Stretching||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|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|
|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||
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.
- visceral adiposity by abdominal CT scan [ Time Frame: 6-months and 12-months ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024816
|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|
|Principal Investigator:||Alka Kanaya, MD||University of California, San Francisco|