Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05964894
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity degree of muscular discomfort', 'timeFrame': 'week 0', 'description': 'self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)'}, {'measure': 'muscle strength', 'timeFrame': 'week 0', 'description': 'grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilograms, the higher the stronger)'}, {'measure': 'severity degree of muscular discomfort', 'timeFrame': 'week 12', 'description': 'self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)'}, {'measure': 'muscle strength', 'timeFrame': 'week 12', 'description': 'grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilograms, the higher the stronger)'}, {'measure': 'severity degree of muscular discomfort', 'timeFrame': 'week 24', 'description': 'self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)'}, {'measure': 'muscle strength', 'timeFrame': 'week 24', 'description': 'grip and pinch power; the muscle strength of neck extension, shoulder flexion/extension, and wrist flexion/extension of the dominant (maximal force of the muscles movement against in kilogram, the higher the stronger)'}], 'secondaryOutcomes': [{'measure': 'Subjective quality of life', 'timeFrame': 'week 0', 'description': 'World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)'}, {'measure': 'Subjective quality of life', 'timeFrame': 'week 24', 'description': 'World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Disorders']}, 'descriptionModule': {'briefSummary': 'This study aimed to examine the effectiveness of the 12-week ergonomic intervention developed by Person-Environment-Occupation (PEO) model in improving musculoskeletal discomfort and muscle strength for hemodialysis nurses. The maintenance effects of the intervention were also evaluated after another 12-week follow-up.', 'detailedDescription': 'Methods A cluster experimental design was used to conduct this study. Participants were recruited from hemodialysis units at two medical centers in Taiwan and had complaints of work-related musculoskeletal disorders (WMSDs) within the past six months. By PEO model, the 12-week intervention including ergonomic education and exercise program was designed based on the job contents of hemodialysis nurses. In the study period, we used a mobile massager app to reminder them and monitor their implementation of exercises. The outcome indicators were measured before and after intervention as well as the follow-up after another 12 weeks. A generalized estimating equations model was adopted to analyze the repeated measurements.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 to 65 years old, which is the legal age range of adult for work in Taiwan\n* registered nurses to work full time in the hemodialysis unit more than 6 months,\n* having complaint of WMSDs within previous 6 months before this study.\n\nExclusion Criteria:\n\n* having no musculoskeletal disorder related to the job\n* to care less than 4 patients in 4 hours, which was below the Taiwan workload reference for nurse in hemodialysis job\n* to have any other consideration to keep from 12- week physical exercise program (such as pregnancy, injury, disease, leave…, etc.).'}, 'identificationModule': {'nctId': 'NCT05964894', 'acronym': 'WMSD', 'briefTitle': 'An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Occupational Therapy for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse', 'orgStudyIdInfo': {'id': 'A-ER-108-235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ergonomic training group', 'description': 'The ergonomic training group received a 12-week ergonomic training program.', 'interventionNames': ['Other: ergonomic training']}, {'type': 'NO_INTERVENTION', 'label': 'No training group', 'description': 'The no training group did not receive any training program.'}], 'interventions': [{'name': 'ergonomic training', 'type': 'OTHER', 'description': 'ergonomic education \\& exercise training', 'armGroupLabels': ['Ergonomic training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'JER-HAO CHANG, PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng Kung University, College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jer-Hao Chang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jer-Hao Chang', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}