Bone HealthNCT02163668
Effects of Yoga on Bone Metabolism in Premenopausal Women
A study testing Yoga Group in people with Bone Health and Osteoporosis, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Health, Osteoporosis
- What is being tested?
- Yoga Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- body weight more than 300 pounds
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Exercise Science, University of Oklahoma
Norman, Oklahoma, 73019
About this study
Official title: 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.
- Conditions
- Bone Health, Osteoporosis
- Being tested
- Yoga Group
- Keywords
- Yoga, Bone turnover markers, Bone strength, Bone mineral density
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga GroupOther
8 months of Yoga training
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | 8 months of progressive Yoga training Receives: Other: Yoga Group |
| Control group | No intervention | No training, just pre and post testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density from baseline to 8 months
Measured: pre and post 8 months training
change in bone turnover markers
Measured: pre and post 8 month intervention
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)
Measured: pre and post 8 month intervention
Changes in muscular strength
Isotonic 1 repetition maximum (1RM) for 4 lower body and 2 upper body resistance exercises
Measured: pre and post 9 month intervention
Change in arterial compliance
Arterial compliance of the large and small arteries was assessed using Pulse Contour analysis.
Measured: pre and post 8 month interventon
Change in Insulin-like Growth Factor-1 (IGF-I) and Insulin-like Growth Factor BP3 (IGFBP3)
Measured: pre and post 8 month intervention
Secondary outcomes (5)
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.
Measured: pre and post 8 month intervention
Menstrual History
This information was used to monitor menstrual characteristics to ensure they were still premenopausal at the post test.
Measured: pre and post 8 month intervention
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.
Measured: At baseline at the same time as other outcomes, about 2 weeks before the beginning of the yoga training
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
Measured: pre and post 8 month intervention
Change in body composition
Measured: pre and post 8 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone HealthStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debra Bemben, University of Oklahoma
- Investigators
- Debra A Bemben, PhD, Principal investigator, Department of Health and Exercise Science, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163668
- Sponsor's protocol ID
- OUYogaStudy
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19891384Chan 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.
PubMed 15129394
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an 8-month Yoga Intervention on Bone Metabolism in Healthy Middle-aged Premenopausal Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02163668
- Acronym / sponsor ID
- OUYogaStudy
- Conditions
- Bone Health, Osteoporosis
- Keywords
- Yoga, Bone turnover markers, Bone strength, Bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Other: Yoga Group8 months of progressive Yoga training |
| Control group | No intervention | –No training, just pre and post testing |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- body weight more than 300 pounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Group8 months of Yoga training | Other | Yoga group |
Primary outcome
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
5 secondary outcomes
Daily Calcium intake
Time frame: pre and post 8 month intervention
Menstrual History
Time frame: 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
Change in physical activity levels
Time frame: pre and post 8 month intervention
Change in body composition
Time frame: pre and post 8 month intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
- Background: PubMed 19891384Phoosuwan 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.
- Background: PubMed 15129394Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra A Bemben, PhD principal investigator
Department of Health and Exercise Science, University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Group in people with Bone Health and Osteoporosis, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density from baseline to 8 months (time frame: pre and post 8 months training). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163668, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.