Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-16 @ 2:08 AM
Study NCT ID:
NCT00572104
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2007-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D059385', 'term': 'Plyometric Exercise'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2007-12-10', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Serum markers of bone turnover', 'timeFrame': '3 months'}, {'measure': 'Serum hormones regulating bone turnover', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteopenia']}, 'descriptionModule': {'briefSummary': 'This study will compare the ability of two types of long term (12 months) weight-bearing exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass of the total body, spine and hip in physically active men with osteopenia.', 'detailedDescription': 'The overall goal of this project is to determine the efficacy of chronic (12 months) plyometric jump training exercise on bone mineral density (BMD) and markers of bone turnover in physically active males cyclists diagnosed with osteopenia below normal bone mineral density of the lumbar spine or hip.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age 25-60 years\n* No symptoms of disease\n* Currently participating in cycling activities an average of 4 hr/wk for the previous 24 months\n* Osteopenia of the lumbar spine and/or hip (T score \\< -1.0 and \\> -2.5 )\n\nExclusion Criteria:\n\n* Medications or supplements that affect bone metabolism or prevent exercise\n* Previous or current medical condition affecting bone health\n* Osteoporosis of the lumbar spine and/or hip (T score \\> -1.0 or \\< -2.5)\n* Cardiovascular disease\n* Metallic implants\n* Current smoker\n* Current regular participation in high-intensity resistance training and/or plyometrics'}, 'identificationModule': {'nctId': 'NCT00572104', 'briefTitle': 'Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia', 'orgStudyIdInfo': {'id': '1095877'}, 'secondaryIdInfos': [{'id': 'R03AR055738', 'link': 'https://reporter.nih.gov/quickSearch/R03AR055738', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'resistance exercise', 'description': '12 month resistance exercise training', 'interventionNames': ['Other: resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': 'plyometric exercise', 'description': '12 month plyometric exercise training', 'interventionNames': ['Other: plyometric exercise']}], 'interventions': [{'name': 'resistance exercise', 'type': 'OTHER', 'description': '12 month training intervention of weight resistance exercise. All participants receive a daily calcium and vitamin D supplement', 'armGroupLabels': ['resistance exercise']}, {'name': 'plyometric exercise', 'type': 'OTHER', 'description': '12 month training intervention of plyometric exercise. All participants receive a daily calcium and vitamin D supplement', 'armGroupLabels': ['plyometric exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri-Columbia; McKee Gym', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Pamela S Hinton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia, Department of Nutritional Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}