Practicing Restorative Yoga or Stretching for the Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— PRYSMS  

Official title:

Practicing Restorative Yoga or Stretching for the Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024816
• Other study ID #: 1R01AT004569-01A2
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: June 24, 2014
• Start date: December 2009
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

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
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California
United States	Unversity of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visceral adiposity by abdominal CT scan		6-months and 12-months	No
Secondary	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).		6-months and 12-months	No

External Links

•   Link