Clinical trial NCT06112106: The Effect of Intelligent Exercise and Ergonomic Recommendations on Surgeon Musculoskeletal Discomfort
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Occupational Injuries
Occupational Exposure
Keywords: Ergonomics
Physical exercise training
Prevention
Rehabilitation
Microbreaks
Surgeons
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Working Environment Research Fund
First posted: 2023-11-01
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Musculoskeletal pain intensity
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Secondary outcomes:
measure: Self-reported use of pain medicine
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
measure: Self-reported time spent on moderate to vigorous physical activity during a regular week (in minutes)
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
measure: Self-reported physical resources
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
measure: Self-reported health
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
measure: Self-reported personal and work-related burnout
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
measure: Self-reported work ability
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
measure: Working conditions
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
measure: Musculoskeletal pain frequency past 3 months
timeFrame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Helle J Christiansen, Msc.
role: PRINCIPAL_INVESTIGATOR
References: