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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restorative yoga
Stretching
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Restorative Yoga, Stretching, Visceral adiposity, Randomized controlled trial

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego
  • Unversity of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Restorative yoga intervention

Stretching group

Arm Description

Outcomes

Primary Outcome Measures

visceral adiposity by abdominal CT scan

Secondary Outcome Measures

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).

Full Information

First Posted
December 1, 2009
Last Updated
June 24, 2014
Sponsor
University of California, San Francisco
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01024816
Brief Title
Practicing Restorative Yoga or Stretching for the Metabolic Syndrome
Acronym
PRYSMS
Official Title
Practicing Restorative Yoga or Stretching for the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, Restorative Yoga, Stretching, Visceral adiposity, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Restorative yoga intervention
Arm Type
Experimental
Arm Title
Stretching group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Restorative yoga
Intervention Description
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
Intervention Name(s)
Stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
visceral adiposity by abdominal CT scan
Time Frame
6-months and 12-months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alka Kanaya, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Unversity of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34425916
Citation
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.
Results Reference
derived
PubMed Identifier
25127084
Citation
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.
Results Reference
derived
Links:
URL
http://coe.ucsf.edu/scor/prysms/
Description
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Practicing Restorative Yoga or Stretching for the Metabolic Syndrome

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