Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT00559806
Status:
COMPLETED
Last Update Posted:
2007-11-16
First Post:
2007-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Aging and Immobilisation on Muscle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-15', 'studyFirstSubmitDate': '2007-11-15', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation', 'timeFrame': '2 weeks of immobilisation and 4 weeks of resistance training'}], 'secondaryOutcomes': [{'measure': 'single muscle fiber area, expression of myostatin and IGF-1 (RNA), changes in satellite activation and number', 'timeFrame': '2 weeks of imm and 4 weeks of resistance training'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immobilisation', 'aging', 'resistance training', 'atrophy', 'The effect of immobilisation in elderly compared to young individuals'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The debilitating effects of immobilisation on muscle strength and size in young individuals are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle strength loss in old age, however, changes in muscle mass and architecture with immobilisation in the elderly has not previously been investigated. This is contrasted by the fact that the elderly population more often undergoes periods of immobilization and disuse not only due to joint pain but also due to a higher degree of co morbidity and hospitalisation.The purpose of the present study was to compare the effect of a 2 week period of unilateral immobilisation on the physiological muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation angle in young and old healthy men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young healthy males (age 20-30 yrs)or old healthy males (age 60-80 yrs)\n\nExclusion Criteria:\n\n* Musculoskeletal disorder\n* Diabetes\n* Cardiovascular disease\n* Neurological diseases; or\n* Cognitive disorders'}, 'identificationModule': {'nctId': 'NCT00559806', 'briefTitle': 'The Effect of Aging and Immobilisation on Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'The Effect of Aging and Immobilisation on Muscle', 'orgStudyIdInfo': {'id': 'KF01-322606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '9 healthy elderly males', 'interventionNames': ['Other: 2 weeks of unilateral immobilisation and 4 weeks of resistance training']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '11 healthy young males', 'interventionNames': ['Other: 2 weeks of unilateral immobilisation and 4 weeks of resistance training']}], 'interventions': [{'name': '2 weeks of unilateral immobilisation and 4 weeks of resistance training', 'type': 'OTHER', 'description': '2 weeks of whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control', 'armGroupLabels': ['1']}, {'name': '2 weeks of unilateral immobilisation and 4 weeks of resistance training', 'type': 'OTHER', 'description': '2 weeks of unilateral whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400-NV', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Institute of Sports Medicine, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Charlotte Suetta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}}}}