Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-06 @ 9:14 PM
Study NCT ID:
NCT00667667
Status:
TERMINATED
Last Update Posted:
2015-05-28
First Post:
2008-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006262', 'term': 'Health'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2008-04-24', 'studyFirstSubmitQcDate': '2008-04-24', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': 'Baseline, 12 months'}], 'secondaryOutcomes': [{'measure': 'muscle strength', 'timeFrame': 'baseline, 12 months'}, {'measure': 'Quality of life', 'timeFrame': 'baseline, 12 month'}, {'measure': 'falls', 'timeFrame': 'daily over 12 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['whole body vibration', 'exercise', 'postmenopausal', 'BMD', 'bone', 'elderly females', 'Caucasian race'], 'conditions': ['Postmenopausal']}, 'referencesModule': {'references': [{'pmid': '17550916', 'type': 'BACKGROUND', 'citation': 'von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. doi: 10.1136/bjsm.2006.033480. Epub 2007 Jun 5.'}, {'pmid': '15746294', 'type': 'BACKGROUND', 'citation': 'Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.'}, {'pmid': '15159265', 'type': 'BACKGROUND', 'citation': 'Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. doi: 10.1001/archinte.164.10.1084.'}], 'seeAlsoLinks': [{'url': 'http://www.imp.uni-erlangen.de/', 'label': 'homepage of the Institute of Medical Physics'}]}, 'descriptionModule': {'briefSummary': 'There is general agreement that physical exercise can positively influence osteoporotic fracture risk along two pathways: first by reducing the risk of falls via an improvement of fall related neuromuscular abilities; second by increasing bone strength.\n\nWhole body vibration (WBV) training has recently been proposed as a new approach for prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be an effective method to improve bone mass, architecture and strength. However, the results of human WBV training studies are rather heterogeneous.\n\nIn the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month lasting study the investigators determine the effect of a thrice weekly WBV training on two different devices on the osteoporotic risk factors: bone mineral density, falls and neuromuscular performance. Particular the investigators compare a bipedal vertical oscillating Plate with a plate which rotates around a central axis leading to a side-alternating loaning.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females 60 - 75 years old\n* caucasian race\n\nExclusion Criteria:\n\n* CHD-diseases\n* thrombosis, embolism\n* fractures at lumbar spine or hip\n* secondary osteoporosis\n* hyperparathyroidism\n* medication, diseases with impact on muscle or bone\n* hip or knee implant'}, 'identificationModule': {'nctId': 'NCT00667667', 'briefTitle': 'Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'OFZ-Elvis-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'vertical vibration device (using Vibrafit whole body vibration platforms)', 'interventionNames': ['Device: vertical vibration device (Vibrafit whole body vibration platform)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'side-alternating vibration device (using Board 3000 whole body vibration platforms)', 'interventionNames': ['Device: side alternating vibration device (Board 3000 whole body vibration platform)']}, {'type': 'SHAM_COMPARATOR', 'label': '3', 'description': 'wellness-control group', 'interventionNames': ['Behavioral: stretching and wellness (control group)']}], 'interventions': [{'name': 'vertical vibration device (Vibrafit whole body vibration platform)', 'type': 'DEVICE', 'description': '3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with vertical device', 'armGroupLabels': ['1']}, {'name': 'side alternating vibration device (Board 3000 whole body vibration platform)', 'type': 'DEVICE', 'description': '3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with side alternating device', 'armGroupLabels': ['2']}, {'name': 'stretching and wellness (control group)', 'type': 'BEHAVIORAL', 'description': '2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Institute of Medical Physics, University of Erlangen-Nurnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Simon O von Stengel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erlangen-Nürnberg Medical School'}, {'name': 'Wolfgang K Kemmler, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instiute of Medical Physics'}, {'name': 'Willi A Kalender, Prof., PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Erlangen-Nürnberg Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Elsbeth-Bonhoff-Stiftung, Berlin', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wolfgang Kemmler', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}