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Effects of Yoga on Bone Metabolism in Premenopausal Women

Primary Purpose

Bone Health, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Group
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Health focused on measuring Yoga, Bone turnover markers, Bone strength, Bone mineral density

Eligibility Criteria

35 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Health and Exercise Science, University of Oklahoma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga group

Control group

Arm Description

8 months of progressive Yoga training

No training, just pre and post testing

Outcomes

Primary Outcome Measures

Change in bone mineral density from baseline to 8 months
change in bone turnover markers
change in tibia bone characteristics
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
Isotonic 1 repetition maximum (1RM) for 4 lower body and 2 upper body resistance exercises
Change in arterial compliance
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)

Secondary Outcome Measures

Daily Calcium intake
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
This information was used to monitor menstrual characteristics to ensure they were still premenopausal at the post test.
Dietary intake
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
Physical activity levels estimated by the bone-specific physical activity (PA) questionnaire to monitor their PA outside of the intervention
Change in body composition

Full Information

First Posted
June 9, 2014
Last Updated
June 13, 2014
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT02163668
Brief Title
Effects of Yoga on Bone Metabolism in Premenopausal Women
Official Title
Effects of an 8-month Yoga Intervention on Bone Metabolism in Healthy Middle-aged Premenopausal Women: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Health, Osteoporosis
Keywords
Yoga, Bone turnover markers, Bone strength, Bone mineral density

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Experimental
Arm Description
8 months of progressive Yoga training
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No training, just pre and post testing
Intervention Type
Other
Intervention Name(s)
Yoga Group
Intervention Description
8 months of Yoga training
Primary Outcome Measure Information:
Title
Change in bone mineral density from baseline to 8 months
Time Frame
pre and post 8 months training
Title
change in bone turnover markers
Time Frame
pre and post 8 month intervention
Title
change in tibia bone characteristics
Description
changes in volumetric bone mineral density and bone strength of the non-dominant tibia assessed by peripheral Quantitative Computed Tomography (pQCT)
Time Frame
pre and post 8 month intervention
Title
Changes in muscular strength
Description
Isotonic 1 repetition maximum (1RM) for 4 lower body and 2 upper body resistance exercises
Time Frame
pre and post 9 month intervention
Title
Change in arterial compliance
Description
Arterial compliance of the large and small arteries was assessed using Pulse Contour analysis.
Time Frame
pre and post 8 month interventon
Title
Change in Insulin-like Growth Factor-1 (IGF-I) and Insulin-like Growth Factor BP3 (IGFBP3)
Time Frame
pre and post 8 month intervention
Secondary Outcome Measure Information:
Title
Daily Calcium intake
Description
Calcium intake is a potential confounding variable. Participants were encouraged to increase their calcium intakes if found to be low before the intervention began.
Time Frame
pre and post 8 month intervention
Title
Menstrual History
Description
This information was used to monitor menstrual characteristics to ensure they were still premenopausal at the post test.
Time Frame
pre and post 8 month intervention
Title
Dietary intake
Description
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.
Time Frame
At baseline at the same time as other outcomes, about 2 weeks before the beginning of the yoga training
Title
Change in physical activity levels
Description
Physical activity levels estimated by the bone-specific physical activity (PA) questionnaire to monitor their PA outside of the intervention
Time Frame
pre and post 8 month intervention
Title
Change in body composition
Time Frame
pre and post 8 month intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra A Bemben, PhD
Organizational Affiliation
Department of Health and Exercise Science, University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health and Exercise Science, University of Oklahoma
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73019
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19891384
Citation
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.
Results Reference
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PubMed Identifier
15129394
Citation
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.
Results Reference
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Effects of Yoga on Bone Metabolism in Premenopausal Women

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