An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse (WMSD)

• ClinicalTrials.gov Identifier: NCT05964894
• Recruitment Status: Completed
• First Posted: July 28, 2023
• Last Update Posted: July 28, 2023
• Sponsor: Jer-Hao Chang
• Information provided by (Responsible Party): Jer-Hao Chang, National Cheng-Kung University Hospital

Tracking Information

• First Submitted Date: July 10, 2023
• First Posted Date: July 28, 2023
• Last Update Posted Date: July 28, 2023
• Actual Study Start Date: August 1, 2019
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 19, 2023)

• severity degree of muscular discomfort [ Time Frame: week 0 ]
  self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
• muscle strength [ Time Frame: week 0 ]
  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)
• severity degree of muscular discomfort [ Time Frame: week 12 ]
  self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
• muscle strength [ Time Frame: week 12 ]
  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)
• severity degree of muscular discomfort [ Time Frame: week 24 ]
  self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
• muscle strength [ Time Frame: week 24 ]
  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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 19, 2023)

• Subjective quality of life [ Time Frame: week 0 ]
  World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)
• Subjective quality of life [ Time Frame: week 24 ]
  World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
• Official Title: Occupational Therapy for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Supportive Care
• Condition: Musculoskeletal Disorders

Intervention

Other: ergonomic training

ergonomic education & exercise training

Study Arms

• Experimental: Ergonomic training group
  The ergonomic training group received a 12-week ergonomic training program.
  Intervention: Other: ergonomic training
• No Intervention: No training group
  The no training group did not receive any training program.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 19, 2023): 38
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 30, 2020
• Actual Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 20 to 65 years old, which is the legal age range of adult for work in Taiwan
• registered nurses to work full time in the hemodialysis unit more than 6 months,
• having complaint of WMSDs within previous 6 months before this study.

Exclusion Criteria:

• having no musculoskeletal disorder related to the job
• to care less than 4 patients in 4 hours, which was below the Taiwan workload reference for nurse in hemodialysis job
• to have any other consideration to keep from 12- week physical exercise program (such as pregnancy, injury, disease, leave…, etc.).

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT05964894
• Other Study ID Numbers: A-ER-108-235
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jer-Hao Chang, National Cheng-Kung University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Jer-Hao Chang
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: JER-HAO CHANG, PH.D.; National Cheng Kung University, College of Medicine

• PRS Account: National Cheng-Kung University Hospital
• Verification Date: July 2023