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Effects of Yoga on Bone Metabolism in Premenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163668
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Debra Bemben, University of Oklahoma

Tracking Information
First Submitted Date  ICMJE June 9, 2014
First Posted Date  ICMJE June 16, 2014
Last Update Posted Date June 16, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • Change in bone mineral density from baseline to 8 months [ Time Frame: pre and post 8 months training ]
  • change in bone turnover markers [ Time Frame: 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)
  • 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
  • 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.
  • Change in Insulin-like Growth Factor-1 (IGF-I) and Insulin-like Growth Factor BP3 (IGFBP3) [ Time Frame: pre and post 8 month intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
  • 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.
  • 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.
  • 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.
  • 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
  • Change in body composition [ Time Frame: pre and post 8 month intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Yoga on Bone Metabolism in Premenopausal Women
Official Title  ICMJE Effects of an 8-month Yoga Intervention on Bone Metabolism in Healthy Middle-aged Premenopausal Women: A Randomized Controlled Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Bone Health
  • Osteoporosis
Intervention  ICMJE Other: Yoga Group
8 months of Yoga training
Study Arms  ICMJE
  • Experimental: Yoga group
    8 months of progressive Yoga training
    Intervention: Other: Yoga Group
  • No Intervention: Control group
    No training, just pre and post testing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2014)
47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163668
Other Study ID Numbers  ICMJE OUYogaStudy
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Debra Bemben, University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Debra A Bemben, PhD Department of Health and Exercise Science, University of Oklahoma
PRS Account University of Oklahoma
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP