- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02163668
Effects of Yoga on Bone Metabolism in Premenopausal Women
June 13, 2014 updated by: Debra Bemben, University of Oklahoma
Effects of an 8-month Yoga Intervention on Bone Metabolism in Healthy Middle-aged Premenopausal Women: A Randomized Controlled Study
This study examined the effects of 8 months of Yoga training on bone density and bone turnover markers in premenopausal women, ages 35-50 years.
The style of Yoga used was power Yoga that involved postures with a jumping component.
The investigators hypothesized that the Yoga intervention would result in beneficial improvements in bone turnover markers, by increasing the bone formation marker and decreasing the bone resorption marker.
Study Overview
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Norman, Oklahoma, United States, 73019
- Department of Health and Exercise Science, University of Oklahoma
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- participants had not been engaged in resistance training or in Yoga exercise for at least 12 months prior to the study
- did not have chronic back or joint problems or cardiovascular disease
- not taking antihypertensive drugs or any medication that affects bone density
- not taking hormonal contraception
- they self-reported having regular menstrual cycles.
Exclusion Criteria:
- body weight more than 300 pounds
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yoga group
8 months of progressive Yoga training
|
8 months of Yoga training
|
No Intervention: Control group
No training, just pre and post testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bone mineral density from baseline to 8 months
Time Frame: pre and post 8 months training
|
pre and post 8 months training
|
|
change in bone turnover markers
Time Frame: pre and post 8 month intervention
|
pre and post 8 month intervention
|
|
change in tibia bone characteristics
Time Frame: pre and post 8 month intervention
|
changes in volumetric bone mineral density and bone strength of the non-dominant tibia assessed by peripheral Quantitative Computed Tomography (pQCT)
|
pre and post 8 month intervention
|
Changes in muscular strength
Time Frame: pre and post 9 month intervention
|
Isotonic 1 repetition maximum (1RM) for 4 lower body and 2 upper body resistance exercises
|
pre and post 9 month intervention
|
Change in arterial compliance
Time Frame: pre and post 8 month interventon
|
Arterial compliance of the large and small arteries was assessed using Pulse Contour analysis.
|
pre and post 8 month interventon
|
Change in Insulin-like Growth Factor-1 (IGF-I) and Insulin-like Growth Factor BP3 (IGFBP3)
Time Frame: pre and post 8 month intervention
|
pre and post 8 month intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Calcium intake
Time Frame: pre and post 8 month intervention
|
Calcium intake is a potential confounding variable.
Participants were encouraged to increase their calcium intakes if found to be low before the intervention began.
|
pre and post 8 month intervention
|
Menstrual History
Time Frame: pre and post 8 month intervention
|
This information was used to monitor menstrual characteristics to ensure they were still premenopausal at the post test.
|
pre and post 8 month intervention
|
Dietary intake
Time Frame: At baseline at the same time as other outcomes, about 2 weeks before the beginning of the yoga training
|
Three day dietary logs were recorded by participants before the exercise intervention.
They were analyzed for caloric intake and nutrient composition using the Diet Analysis Plus 9 software.
|
At baseline at the same time as other outcomes, about 2 weeks before the beginning of the yoga training
|
Change in physical activity levels
Time Frame: pre and post 8 month intervention
|
Physical activity levels estimated by the bone-specific physical activity (PA) questionnaire to monitor their PA outside of the intervention
|
pre and post 8 month intervention
|
Change in body composition
Time Frame: pre and post 8 month intervention
|
pre and post 8 month intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Debra A Bemben, PhD, Department of Health and Exercise Science, University of Oklahoma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Phoosuwan M, Kritpet T, Yuktanandana P. The effects of weight bearing yoga training on the bone resorption markers of the postmenopausal women. J Med Assoc Thai. 2009 Sep;92 Suppl5:S102-8.
- Chan K, Qin L, Lau M, Woo J, Au S, Choy W, Lee K, Lee S. A randomized, prospective study of the effects of Tai Chi Chun exercise on bone mineral density in postmenopausal women. Arch Phys Med Rehabil. 2004 May;85(5):717-22. doi: 10.1016/j.apmr.2003.08.091.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
June 9, 2014
First Submitted That Met QC Criteria
June 13, 2014
First Posted (Estimate)
June 16, 2014
Study Record Updates
Last Update Posted (Estimate)
June 16, 2014
Last Update Submitted That Met QC Criteria
June 13, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OUYogaStudy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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