Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT01007669
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2009-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Specified Work Site Physical Activity Intervention Among Employees With Physical Heavy Work
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle strength', 'timeFrame': '3 months'}, {'measure': 'Aerobic capacity', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Questionnaire', 'timeFrame': '1 year'}, {'measure': 'Health Check', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Physical activity'], 'conditions': ['Musculoskeletal Diseases']}, 'referencesModule': {'references': [{'pmid': '27097799', 'type': 'DERIVED', 'citation': 'Gram B, Westgate K, Karstad K, Holtermann A, Sogaard K, Brage S, Sjogaard G. Occupational and leisure-time physical activity and workload among construction workers - a randomized control study. Int J Occup Environ Health. 2016 Jan;22(1):36-44. doi: 10.1080/10773525.2016.1142724. Epub 2016 Apr 21.'}, {'pmid': '20214807', 'type': 'DERIVED', 'citation': 'Holtermann A, Jorgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjogaard G, Sogaard K. Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE. BMC Public Health. 2010 Mar 9;10:120. doi: 10.1186/1471-2458-10-120.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of specified worksite physical-activity interventions on musculoskeletal disorders in an industry with physical heavy workload.', 'detailedDescription': 'Studies regarding company adjusted intervention have shown positive effects regarding work related neck and shoulder symptoms among workers with monotonous repetitive work. However, limited research is available on physical exercise intervention among workers with physically heavy work. This study introduces a new intervention concept to treat and prevent musculoskeletal disorders including individually and health check based exercise intervention.\n\nThe aim of this randomized controlled intervention project is\n\n1. Through Health check to outline the extent musculoskeletal disability in workers with heavy work load in relation to physical and metabolic fitness. Includes is also assessment of physical general activity and working conditions.\n2. To evaluate the effect of individual adjusted exercise programs on muscle strength, aerobic capacity, musculoskeletal disability, pain, work ability and sick absenteeism'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Constructions workers, working for more than 20 hours pr week, Physical heavy work tasks (in Danish: brolæggere, rørlæggere, mekanikere)\n\nExclusion Criteria:\n\n* Workers with flexible job i.e. for people with a reduced ability to work'}, 'identificationModule': {'nctId': 'NCT01007669', 'briefTitle': 'Effects of Specified Work Site Physical Activity Intervention Among Employees With Physical Heavy Work', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Effects of Specified Work Site Physical Activity Intervention on Musculoskeletal Disorders Among Employees With Physical Heavy Work', 'orgStudyIdInfo': {'id': 's-20090058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'Health check only', 'interventionNames': ['Behavioral: Health check only']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Physical activity and Health check', 'interventionNames': ['Behavioral: Physical activity and Health check']}], 'interventions': [{'name': 'Physical activity and Health check', 'type': 'BEHAVIORAL', 'description': 'Strength training, aerobic capacity training.', 'armGroupLabels': ['Intervention']}, {'name': 'Health check only', 'type': 'BEHAVIORAL', 'description': 'Health check', 'armGroupLabels': ['Reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-5230', 'city': 'Odense', 'country': 'Denmark', 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Bibi Gram, M.Sc.,PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bibi Gram', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ph.D student', 'investigatorFullName': 'Bibi Gram', 'investigatorAffiliation': 'University of Southern Denmark'}}}}