Yoga for the Treatment of Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT00605436|
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : January 31, 2008
We tested the following hypotheses:
- That a standardized yoga therapy will improve insulin sensitivity (primary outcome), and other features of the metabolic syndrome such as hypertension and dyslipidemia (secondary outcomes), we will perform a 2-hour oral glucose tolerance test, fasting blood tests, and a physical examination before and after randomization of subjects to a 10-week yoga therapy intervention or wait-list control group.
- That a yoga therapy is feasible in overweight and underactive individuals with the metabolic syndrome, that adherence to a yoga intervention is acceptable, and that yoga therapy is associated with improved quality of life, we will assess the adherence to twice-weekly yoga group sessions (for weeks1-5) and weekly yoga group sessions (for weeks 6-10), frequency of home yoga therapy practice, and self-reported quality of life before and after the intervention in both treatment groups.
- To elucidate a potential mechanism for the effect of yoga on changes in insulin resistance by evaluating markers of inflammation from adipose tissue (adipocytokines). We hypothesize that these biochemical parameters will show modest improvement with yoga therapy and that changes in these parameters will be associated with improvements in insulin sensitivity.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: Restorative yoga therapy||Phase 1|
Study Interventions: There will be a 12-week intervention period.
- Yoga Therapy Group: Those randomized to yoga therapy will receive twice-weekly group yoga sessions at the Osher Center for the entire intervention period. The yoga postures and breathing techniques will be taught by a qualified and certified yoga instructor using a standardized protocol that was determined by a Yoga Expert Panel. Each group yoga session will take approximately 90 minutes. Participants will also be required to practice yoga at home at least 3 times per week, and be given yoga materials (mat, blocks, straps), an instruction manual, and a video for their use at home. They will be asked to keep a calendar log of the dates/times that they practiced yoga at home. This group will also receive a 20-30 minute session with a counselor to discuss Standard Health Education at the beginning of the 12-week intervention. This session will be similar to the control group intervention.
- Standard Health Education Group: Participants assigned to the standard health education group will receive an individual 20-30 minute session with a trained research associate within a week of their baseline visit. In this session, participants will be informed of the importance of a healthy lifestyle, given written information of the Food Guide Pyramid12 and told to follow the equivalent of the National Cholesterol Education Program Step I diet13. They will be counseled to reduce weight and increase physical activity. This is similar to the intervention given to the "Standard Lifestyle Group" in the Diabetes Prevention Program4.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Restorative Yoga for Therapy of the Metabolic Syndrome: A Pilot Trial|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||June 2007|
Restorative yoga therapy group: one orientation workshop for 3 hours, then twice-weekly group yoga therapy classes for first 5 weeks followed by once-weekly group yoga classes for another 5 weeks. The group will also be asked to practice their yoga postures at home for 30 minutes three times per week.
Behavioral: Restorative yoga therapy
3-hour workshop at study initiation. Then twice-weekly group yoga classes for 5 weeks, then once-weekly group yoga classes for 5 weeks. Home yoga practice for 90 minutes/week throughout the 10 week trial.
No Intervention: B
The control group is a wait-list control group with no active intervention.
- Fasting plasma glucose level [ Time Frame: 10 weeks ]
- Feasability of yoga postures [ Time Frame: 10 weeks ]
- Adherence to protocol [ Time Frame: 10 weeks ]
- Blood pressure [ Time Frame: 10 weeks ]
- Insulin sensitivity [ Time Frame: 10 weeks ]
- Weight [ Time Frame: 10 weeks ]
- Waist circumference [ Time Frame: 10 weeks ]
- Heart rate variability [ Time Frame: 10 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605436
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Alka M. Kanaya, MD||University of California, San Francisco|
|Principal Investigator:||Deborah Grady, MD, MPH||University of California, San Francisco|