Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT01177761
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2010-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Erlangen Fitness and Prevention Study (EFOPS).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2010-08-06', 'studyFirstSubmitQcDate': '2010-08-06', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall-fractures (low-trauma)', 'timeFrame': '16 year follow-up', 'description': 'As assessed by questionnaire and structured interview'}, {'measure': 'Bone Mineral Density at Lumbar Spine and Proximal Femur', 'timeFrame': '16 year follow-up', 'description': 'As assessed by Dual-Energy X-ray Absorptiometry (DEXA)'}], 'secondaryOutcomes': [{'measure': '10-year coronary heart disease (CHD) risk', 'timeFrame': '16 year follow-up', 'description': 'As assessed by Framingham Risk Factor Calculator according to Wilson.'}, {'measure': 'Metabolic Syndrome Z-Score', 'timeFrame': '16 year follow-up', 'description': 'Metabolic Syndrome Z-Score Index according to Johnson'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'exercise', 'fractures', 'Bone Mineral Density', 'CHD-risk'], 'conditions': ['Osteoporosis', 'Osteopenia', 'Early Postmenopause']}, 'referencesModule': {'references': [{'pmid': '21625881', 'type': 'BACKGROUND', 'citation': 'Kemmler W, von Stengel S, Bebenek M, Engelke K, Hentschke C, Kalender WA. Exercise and fractures in postmenopausal women: 12-year results of the Erlangen Fitness and Osteoporosis Prevention Study (EFOPS). Osteoporos Int. 2012 Apr;23(4):1267-76. doi: 10.1007/s00198-011-1663-5. Epub 2011 May 28.'}, {'pmid': '23190199', 'type': 'BACKGROUND', 'citation': 'Kemmler W, von Stengel S. Dose-response effect of exercise frequency on bone mineral density in post-menopausal, osteopenic women. Scand J Med Sci Sports. 2014 Jun;24(3):526-34. doi: 10.1111/sms.12024. Epub 2012 Nov 28.'}, {'pmid': '16096715', 'type': 'RESULT', 'citation': 'Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epub 2005 Aug 12.'}, {'pmid': '17313298', 'type': 'RESULT', 'citation': 'Kemmler W, Engelke K, von Stengel S, Weineck J, Lauber D, Kalender WA. Long-term four-year exercise has a positive effect on menopausal risk factors: the Erlangen Fitness Osteoporosis Prevention Study. J Strength Cond Res. 2007 Feb;21(1):232-9. doi: 10.1519/R-20826.1.'}, {'pmid': '15746294', 'type': 'RESULT', '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': 'RESULT', '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.'}, {'pmid': '14504954', 'type': 'RESULT', 'citation': 'Kemmler W, Wildt L, Engelke K, Pintag R, Pavel M, Bracher B, Weineck J, Kalender W. Acute hormonal responses of a high impact physical exercise session in early postmenopausal women. Eur J Appl Physiol. 2003 Sep;90(1-2):199-209. doi: 10.1007/s00421-003-0874-7. Epub 2003 Jul 9.'}, {'pmid': '23983804', 'type': 'DERIVED', 'citation': 'Kemmler W, von Stengel S, Bebenek M, Kalender WA. Long-term exercise and risk of metabolic and cardiac diseases: the erlangen fitness and prevention study. Evid Based Complement Alternat Med. 2013;2013:768431. doi: 10.1155/2013/768431. Epub 2013 Jul 30.'}], 'seeAlsoLinks': [{'url': 'http://www.imp.uni-erlangen.de/', 'label': 'homepage Institute of Medical Physics University of Erlangen-Nürnberg'}]}, 'descriptionModule': {'briefSummary': 'The study determines the long-term effect of exercise on osteoporotic fracture risk. Since actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce. Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled exercise study with currently 16 years of supervised exercise with 45-50 osteopenic, early-postmenopausal women in exercise and sedentary control group each, the investigators therefore focus on overall-fractures, Bone Mineral Density and falls.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '48 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants of the EFOPS-study,\n* 12 years of exercise training according to the EFOPS-protocol (exercise).\n\nExclusion Criteria:\n\n* medication and diseases affecting bone metabolism,\n* inflammable diseases,\n* cardiovascular diseases,\n* start of relevant physical exercise programs beside the EFOPS protocol.'}, 'identificationModule': {'nctId': 'NCT01177761', 'acronym': 'EFOPS', 'briefTitle': 'The Erlangen Fitness and Prevention Study (EFOPS).', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Effects of Exercise on Fracture Risk, Bone Mineral Density and Falls in Postmenopausal Women. The Long-term Erlangen Fitness and Prevention Study.', 'orgStudyIdInfo': {'id': 'OFZ-EFOPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'exercise', 'description': 'endurance,balance, power, resistance type exercise', 'interventionNames': ['Procedure: physical exercise']}, {'type': 'NO_INTERVENTION', 'label': 'sedentary control', 'description': 'Subjects were instructed to do not relevantly change their lifestyle'}], 'interventions': [{'name': 'physical exercise', 'type': 'PROCEDURE', 'description': 'Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training', 'armGroupLabels': ['exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Institute of Medical Physics, University of Erlangen-Nurnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Willi A Kalender, PHD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Erlangen-Nürnberg Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Behinderten- und Versehrten-Sportverband Bayern e.V.', 'class': 'OTHER'}, {'name': 'Netzwerk Knochengesundheit e.V.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. Wolfgang Kemmler', 'investigatorFullName': 'Wolfgang Kemmler', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}