Skip to main content
Clinical Trials/NCT06112106
NCT06112106
Enrolling By Invitation
Not Applicable

A Multi-center, Randomized, Parallel-group, 4-month Study to Compare the Effect of Ergonomic Recommendations Versus Intelligent Physical Exercise Training (IPET) and Ergonomic Recommendations on Musculoskeletal Pain Among Abdominal and Pelvic Surgeons.

University of Aarhus7 sites in 2 countries170 target enrollmentDecember 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Occupational Injuries
Sponsor
University of Aarhus
Enrollment
170
Locations
7
Primary Endpoint
Musculoskeletal pain intensity
Status
Enrolling By Invitation
Last Updated
8 months ago

Overview

Brief Summary

The goal of this clinical trial is to investigate the effects of Intelligent Physical Exercise Training (IPET) and ergonomic recommendations on musculoskeletal pain among abdominal and pelvic surgeons. The main question it aims to answer is:

• Is IPET superior to ergonomic recommendations in rehabilitating or preventing musculoskeletal pain?

12 weeks ahead of trial start, all participants will be familiarized with ergonomic principles in the operating room. In the 20-week trial, the control group is asked to resume practicing and applying the ergonomic principles when they operate. In addition to applying the ergonomic principles, the Intervention group will be asked to perform 50 min. per week of individually tailored physical exercise training. The program is delivered via an application (app).

Detailed Description

Pre-intervention The three months leading up to the trial start, all participants are introduced to up-to-date ergonomic recommendations. The ergonomic recommendations are informed by general ergonomic recommendations from the Danish Working Environment Authority, a systematic literature review on the effect of ergonomic interventions applied in the OR (REF and general ergonomic guidelines) and include two recommendations: 1) performing intra-operative microbreaks, and 2) knowledge of ergonomic work posture in the OR. InterventionIntelligent Exercise app + ergonomic recommendations The duration of the ergonomic recommendations launch period is three months after which consenting participants will be randomized to either the control group or the intervention group. The control group will be encouraged to continue to apply the up-to-date ergonomic recommendations to their OR practice, this will act as usual care. In addition to the usual care, the intervention group will be prescribed individualized physical exercise training (IPET). The IPET is 50 min of tailored physical exercise per week, that is designed by an algorithm that uses the information (demographics, self-reported health, musculoskeletal pain and its location) the individual enters in the app (REF). The 50 min. Of total IPET per week can be performed in one session or divided into shorter sessions two-five sessions with the same effect (REF). The IPET will be delivered through the participants' mobile phone via a mobile application (app) that requires a unique code assigned for each participant. Each participant's exercise training program is different because it is composed of the input provided by the participant. Thus, as the participants experience progress (or deterioration) in their physical capacity during the study, the program will change accordingly.

Registry
clinicaltrials.gov
Start Date
December 13, 2023
End Date
June 1, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Surgeon in gynecologic-, urologic, colorectal or abdominal surgery
  • Performs an average of four hours of surgery per week

Exclusion Criteria

  • Own physician has advised against performing physical exercise training

Outcomes

Primary Outcomes

Musculoskeletal pain intensity

Time Frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)

Pain intensity on a 11-point Likert scale (0= no pain, 10= most intense pain) the past 3 months and last 7 days in neck, shoulders, elbows/arms, wrists/hands, upper back, lower back, hips, knees, ankle/feet

Secondary Outcomes

  • Self-reported use of pain medicine(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
  • Self-reported time spent on moderate to vigorous physical activity during a regular week (in minutes)(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
  • Self-reported physical resources(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
  • Self-reported health(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
  • Self-reported personal and work-related burnout(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
  • Working conditions(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
  • Self-reported work ability(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
  • Musculoskeletal pain frequency past 3 months(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))

Study Sites (7)

Loading locations...

Similar Trials