Musculoskeletal DisordersWMSDNCT05964894
An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
A study testing ergonomic training in people with Musculoskeletal Disorders, run by Jer-Hao Chang at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- ergonomic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Disorders
- Being tested
- ergonomic training
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergonomic trainingOther
ergonomic education \& exercise training
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic training group | Experimental | The ergonomic training group received a 12-week ergonomic training program. Receives: Other: ergonomic training |
| No training group | No intervention | The no training group did not receive any training program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity degree of muscular discomfort
self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
Measured: week 0
muscle strength
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)
Measured: week 0
severity degree of muscular discomfort
self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
Measured: week 12
muscle strength
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)
Measured: week 12
severity degree of muscular discomfort
self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)
Measured: week 24
muscle strength
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)
Measured: week 24
Secondary outcomes (2)
Subjective quality of life
World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)
Measured: week 0
Subjective quality of life
World Health Organization Quality of Life, Brief edition, Taiwan version (1-5, higher score for higher quality of life)
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Aug 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jer-Hao Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jer-Hao Chang, National Cheng-Kung University Hospital
- Investigators
- JER-HAO CHANG, PH.D., Principal investigator, National Cheng Kung University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964894
- Sponsor's protocol ID
- A-ER-108-235
- Acronym
- WMSD
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
- ClinicalTrials.gov ID
- NCT05964894
- Acronym / sponsor ID
- WMSD / A-ER-108-235
- Conditions
- Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Jer-Hao ChangUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergonomic training group | Experimental | Other: ergonomic trainingThe ergonomic training group received a 12-week ergonomic training program. |
| No training group | No intervention | –The no training group did not receive any training program. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ergonomic trainingergonomic education \& exercise training | Other | Ergonomic training group |
Primary outcome
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)
2 secondary outcomes
Subjective quality of life
Time frame: week 0
Subjective quality of life
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JER-HAO CHANG, PH.D. principal investigator
National Cheng Kung University, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ergonomic training in people with Musculoskeletal Disorders, run by Jer-Hao Chang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity degree of muscular discomfort (time frame: week 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.