- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05964894
An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse (WMSD)
July 19, 2023 updated by: Jer-Hao Chang
Occupational Therapy for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tainan, Taiwan, 701
- National Cheng Kung University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ergonomic training group
The ergonomic training group received a 12-week ergonomic training program.
|
ergonomic education & exercise training
|
|
No Intervention: No training group
The no training group did not receive any training program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
week 0
|
|
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)
|
week 0
|
|
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)
|
week 12
|
|
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)
|
week 12
|
|
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)
|
week 24
|
|
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)
|
week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
week 0
|
|
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)
|
week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JER-HAO CHANG, PH.D., National Cheng Kung University, College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
July 19, 2023
First Posted (Actual)
July 28, 2023
Study Record Updates
Last Update Posted (Actual)
July 28, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-ER-108-235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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