Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-17 @ 6:39 PM
Study NCT ID:
NCT02163668
Status:
COMPLETED
Last Update Posted:
2014-06-16
First Post:
2014-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Yoga on Bone Metabolism in Premenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2014-06-09', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bone mineral density from baseline to 8 months', 'timeFrame': 'pre and post 8 months training'}, {'measure': 'change in bone turnover markers', 'timeFrame': 'pre and post 8 month intervention'}, {'measure': 'change in tibia bone characteristics', 'timeFrame': 'pre and post 8 month intervention', 'description': 'changes in volumetric bone mineral density and bone strength of the non-dominant tibia assessed by peripheral Quantitative Computed Tomography (pQCT)'}, {'measure': 'Changes in muscular strength', 'timeFrame': 'pre and post 9 month intervention', 'description': 'Isotonic 1 repetition maximum (1RM) for 4 lower body and 2 upper body resistance exercises'}, {'measure': 'Change in arterial compliance', 'timeFrame': 'pre and post 8 month interventon', 'description': 'Arterial compliance of the large and small arteries was assessed using Pulse Contour analysis.'}, {'measure': 'Change in Insulin-like Growth Factor-1 (IGF-I) and Insulin-like Growth Factor BP3 (IGFBP3)', 'timeFrame': 'pre and post 8 month intervention'}], 'secondaryOutcomes': [{'measure': 'Daily Calcium intake', 'timeFrame': 'pre and post 8 month intervention', '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.'}, {'measure': 'Menstrual History', 'timeFrame': 'pre and post 8 month intervention', 'description': 'This information was used to monitor menstrual characteristics to ensure they were still premenopausal at the post test.'}, {'measure': 'Dietary intake', 'timeFrame': 'At baseline at the same time as other outcomes, about 2 weeks before the beginning of the yoga training', '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.'}, {'measure': 'Change in physical activity levels', 'timeFrame': 'pre and post 8 month intervention', 'description': 'Physical activity levels estimated by the bone-specific physical activity (PA) questionnaire to monitor their PA outside of the intervention'}, {'measure': 'Change in body composition', 'timeFrame': 'pre and post 8 month intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Yoga', 'Bone turnover markers', 'Bone strength', 'Bone mineral density'], 'conditions': ['Bone Health', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '19891384', 'type': 'BACKGROUND', '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.'}, {'pmid': '15129394', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants had not been engaged in resistance training or in Yoga exercise for at least 12 months prior to the study\n* did not have chronic back or joint problems or cardiovascular disease\n* not taking antihypertensive drugs or any medication that affects bone density\n* not taking hormonal contraception\n* they self-reported having regular menstrual cycles.\n\nExclusion Criteria:\n\n* body weight more than 300 pounds'}, 'identificationModule': {'nctId': 'NCT02163668', 'briefTitle': 'Effects of Yoga on Bone Metabolism in Premenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Effects of an 8-month Yoga Intervention on Bone Metabolism in Healthy Middle-aged Premenopausal Women: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'OUYogaStudy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga group', 'description': '8 months of progressive Yoga training', 'interventionNames': ['Other: Yoga Group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No training, just pre and post testing'}], 'interventions': [{'name': 'Yoga Group', 'type': 'OTHER', 'description': '8 months of Yoga training', 'armGroupLabels': ['Yoga group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73019', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Department of Health and Exercise Science, University of Oklahoma', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}], 'overallOfficials': [{'name': 'Debra A Bemben, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Health and Exercise Science, University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Debra Bemben', 'investigatorAffiliation': 'University of Oklahoma'}}}}