NCT05964894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

July 10, 2023

Last Update Submit

July 19, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • severity degree of muscular discomfort

    self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)

    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)

    week 0

  • severity degree of muscular discomfort

    self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)

    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)

    week 12

  • severity degree of muscular discomfort

    self reported by Nordic Musculoskeletal Questionnaire (0-5 points; the higher score indicates the more discomfort)

    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)

    week 24

Secondary Outcomes (2)

  • Subjective quality of life

    week 0

  • Subjective quality of life

    week 24

Study Arms (2)

Ergonomic training group

EXPERIMENTAL

The ergonomic training group received a 12-week ergonomic training program.

Other: ergonomic training

No training group

NO INTERVENTION

The no training group did not receive any training program.

Interventions

ergonomic education \& exercise training

Ergonomic training group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • JER-HAO CHANG, PH.D.

    National Cheng Kung University, College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 28, 2023

Study Start

August 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations