Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-25 @ 1:26 PM
Study NCT ID:
NCT00783159
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2008-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fit in the Aged by Professional Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2008-10-30', 'studyFirstSubmitQcDate': '2008-10-30', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short physical performance battery', 'timeFrame': '3 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Muscle strength and muscle power', 'timeFrame': '3 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Muscle power', 'Frailty', 'Exercise', 'Vitamin D'], 'conditions': ['Frailty', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '41397660', 'type': 'DERIVED', 'citation': 'Rippl M, Bidlingmaier M, Deissler L, Martini S, Mueller K, Schluessel S, Schmidmaier R, Schweizer JROL, Tausendfreund O, Welscher L, Drey M. Strength but not power training increases soluble alpha klotho levels in pre-frail older adults. Exp Gerontol. 2025 Dec 13:113002. doi: 10.1016/j.exger.2025.113002. Online ahead of print.'}, {'pmid': '36037722', 'type': 'DERIVED', 'citation': 'Schaupp A, Bidlingmaier M, Martini S, Reincke M, Schluessel S, Schmidmaier R, Drey M. Resistance training-induced improvement in physical function is not associated to changes in endocrine somatotropic activity in prefrail older adults. Arch Gerontol Geriatr. 2022 Nov-Dec;103:104792. doi: 10.1016/j.archger.2022.104792. Epub 2022 Aug 14.'}, {'pmid': '23134737', 'type': 'DERIVED', 'citation': 'Zech A, Drey M, Freiberger E, Hentschke C, Bauer JM, Sieber CC, Pfeifer K. Residual effects of muscle strength and muscle power training and detraining on physical function in community-dwelling prefrail older adults: a randomized controlled trial. BMC Geriatr. 2012 Nov 7;12:68. doi: 10.1186/1471-2318-12-68.'}, {'pmid': '22056537', 'type': 'DERIVED', 'citation': 'Drey M, Zech A, Freiberger E, Bertsch T, Uter W, Sieber CC, Pfeifer K, Bauer JM. Effects of strength training versus power training on physical performance in prefrail community-dwelling older adults. Gerontology. 2012;58(3):197-204. doi: 10.1159/000332207. Epub 2011 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'This intervention study tests training methods to stabilize or improve functionality in the high risk group of prefrail elderly persons.', 'detailedDescription': 'This study aims at the improvement of muscular function by physical exercise in prefrail elderly persons. Prefrail participants are recruited according to the frailty score of Fried. Taking into account, that vitamin D supplementation reduces falls and improves muscle strength in older people, all participants are supplemented by vitamin D. Two different training methods are tested.\n\nAfter a run-in period of supplementation of vitamin D for two months, participants will be randomized into three different equally sized groups (n=25): Group A will receive power training. Group B will have progressive strength training. Group C will serve as a control group. They will receive a consultation about leading a healthy life with special attention being paid to nutrition and physical activity. The intervention period lasts for 12 weeks. The 60 minutes training sessions will be held two times a week by members of the Institute of Sport Science and Sports of the University of Erlangen-Nuremberg. Follow-up visits are scheduled three and six months after intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prefrailty according to the frailty score of Fried\n\nExclusion Criteria:\n\n* Sarcoidosis\n* Nephrolithiasis\n* Plasmacytoma\n* COPD\n* Inflammatory bowel disease\n* Rheumatoid arthritis\n* History of cancer\n* Instable heart disease\n* Depression (GDS\\>=6)\n* Dementia (MMSE\\<=24)\n* BMI\\>35kg/m²\n* Current attendance of muscle training\n* Medication: immunosuppressive drugs'}, 'identificationModule': {'nctId': 'NCT00783159', 'acronym': 'FiAT', 'briefTitle': 'Fit in the Aged by Professional Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'The Effect of Different Training Modalities and Vitamin D Supplementation on Functionality in Prefrail Elderly Persons', 'orgStudyIdInfo': {'id': '32.5.8051.0113.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Training I', 'interventionNames': ['Procedure: Power Training']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Training II', 'interventionNames': ['Procedure: Strength Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'description': 'Control', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Power Training', 'type': 'PROCEDURE', 'description': 'Power training, Vitamin D substitution', 'armGroupLabels': ['A']}, {'name': 'Strength Training', 'type': 'PROCEDURE', 'description': 'Strength training, Vitamin D substitution', 'armGroupLabels': ['B']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Vitamin D substitution, Lifestyle consultation', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Institute of Biomedicine of Aging', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Cornel C. Sieber, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erlangen-Nürnberg'}, {'name': 'Klaus Pfeifer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Erlangen-Nürnberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinikum Nürnberg', 'class': 'OTHER'}, {'name': 'Institute of Biomedicine of Aging', 'class': 'UNKNOWN'}, {'name': 'University of Erlangen-Nürnberg', 'class': 'OTHER'}, {'name': 'Institute of Sport Science and Sport', 'class': 'UNKNOWN'}, {'name': 'Robert Bosch Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}