Practicing Restorative Yoga or Stretching for the Metabolic Syndrome

NCT ID: NCT01024816

Last Updated: 2014-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Restorative yoga intervention

Group Type EXPERIMENTAL

Restorative yoga

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Stretching

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alka Kanaya, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Unversity of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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Flowers E, Allen IE, Kanaya AM, Aouizerat BE. Circulating MicroRNAs predict glycemic improvement and response to a behavioral intervention. Biomark Res. 2021 Aug 23;9(1):65. doi: 10.1186/s40364-021-00317-5.

Reference Type DERIVED
PMID: 34425916 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25127084 (View on PubMed)

Related Links

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Other Identifiers

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1R01AT004569-01A2

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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