The Effect of Intelligent Exercise and Ergonomic Recommendations on Surgeon Musculoskeletal Discomfort

NCT06112106 | Enrolling By Invitation

• 1 other identifier: 20205100734
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 7

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).

Conditions

Occupational Injuries; Occupational Exposure

Keywords

Ergonomics; Physical exercise training; Prevention; Rehabilitation; Microbreaks; Surgeons

Outcome Measures

Primary Outcomes (1)

• Musculoskeletal pain intensity

  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

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

Secondary Outcomes (8)

• 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)

Study Arms (2)

Control group

NO INTERVENTION

Surgeons assigned to the control group will be asked (to continue) to apply the ergonomic recommendations in the daily practice introduced three months ahead of trial start.

Intervention group

EXPERIMENTAL

Surgeons

Behavioral: Intelligent Physical Exercise Training (IPET)

Interventions

Intelligent Physical Exercise Training (IPET) BEHAVIORAL

The intervention group will follow an Intelligent Physical Exercise training (IPET) program delivered via a mobile phone app. The scope of the physical exercise program is 50 minutes per week, and it is individually tailored according to questionnaire responses about work profile, physical capacity, health status and extent of musculoskeletal pain.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Own physician has advised against performing physical exercise training

Sponsors & Collaborators

• University of Aarhus: lead
• The Working Environment Research Fund: collaborator

Study Sites (7)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Aarhus University

Aarhus, 5500, Denmark

Location

Gødstrup Regional Hospital

Gødstrup, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Randers Regional Hospital

Randers, Denmark

Location

Sygehus Lillebælt, Vejle

Vejle, Denmark

Location

Related Publications (1)

• Christiansen HJ, Sandal LF, Mogensen O, Norasi H, Chrouser K, Hallbeck MS, Jensen PT, Dalager T. Prevention and rehabilitation of musculoskeletal pain among abdominal and pelvic surgeons with intelligent physical exercise training (IPET) and intraoperative ergonomic recommendations (ERGO): study protocol for a multicenter open-label randomized controlled trial in Denmark and North America (USA). Trials. 2025 Dec 12;26(1):565. doi: 10.1186/s13063-025-09178-x.

  PMID: 41388556 DERIVED

MeSH Terms

Conditions

Occupational Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Helle J Christiansen, Msc.

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator who performs the statistical analysis will be masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: November 1, 2023
• Study Start: December 13, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); DK (5)