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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01024816
First received: December 1, 2009
Last updated: June 24, 2014
Last verified: June 2014

December 1, 2009
June 24, 2014
December 2009
July 2012   (final data collection date for primary outcome measure)
visceral adiposity by abdominal CT scan [ Time Frame: 6-months and 12-months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01024816 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Practicing Restorative Yoga or Stretching for the Metabolic Syndrome
Practicing Restorative Yoga or Stretching for the Metabolic Syndrome

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Metabolic Syndrome
  • 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

  • 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.

  • Experimental: Restorative yoga intervention
    Intervention: Behavioral: Restorative yoga
  • Active Comparator: Stretching group
    Intervention: Behavioral: Stretching
Corey SM, Epel E, Schembri M, Pawlowsky SB, Cole RJ, Araneta MR, Barrett-Connor E, Kanaya AM. Effect of restorative yoga vs. stretching on diurnal cortisol dynamics and psychosocial outcomes in individuals with the metabolic syndrome: the PRYSMS randomized controlled trial. Psychoneuroendocrinology. 2014 Nov;49:260-71. doi: 10.1016/j.psyneuen.2014.07.012. Epub 2014 Jul 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
May 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01024816
1R01AT004569-01A2
Yes
University of California, San Francisco
University of California, San Francisco
University of California, San Diego
Principal Investigator: Alka Kanaya, MD University of California, San Francisco
University of California, San Francisco
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP