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

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Occupational Exposure; Occupational Injuries
• Intervention / Treatment: Behavioral: Intelligent Physical Exercise Training (IPET)

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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helle J Christiansen, Msc.; Phone Number: +4550176163; Email: hjchristiansen@clin.au.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 5500
    • Recruiting
    • Aarhus University
    • Contact: Helle Joon Christiansen; Phone Number: +4550176163; Email: hjchristiansen@clin.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Experimental: Intervention group; Surgeons	Behavioral: Intelligent Physical Exercise Training (IPET); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal pain frequency past 3 months	Pain frequency for the past 3 months (possible answers: 0d, 1 to 7d, 8 to 30d, more than 30 days but not every day, every day)	Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported use of pain medicine	Use of pain medicine due to musculoskeletal pain. Answer categories: daily, one to several times a week, one to several times a month, rarely or never	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)	Accumulated physical activity during a regular week (hours/minutes). Answer categories for moderate physical activity: less than 30 min., 30-90 min., 90-149 min., 150-299 min., 300 min. or more. Answer categories for vigorous physical activity: less than 30 min, 30-89 min, 90-149 min, 150 min. or more.	Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported physical resources	Rating own physical resources (cardiorespiratory fitness, strength, balance) compared to peers on a Likert scale (0= poor, 10= good).	Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported health	General health answer categories: On a five-point Likert scale (0= excellent, 5= poor). Physical and mental health rated on various likert scales.	Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported personal and work-related burnout	The Copenhagen Burnout Inventory. Answer categories: 5-point Likert scales from "always" to "almost never or never", or from "very much" to "very little"	Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported work ability	The Work Ability Index (WAI) contains questions concerning work, work ability and health.	Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Working conditions	Surgical specialty, weekly workings hours as primary and assisting surgeon	Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: The Working Environment Research Fund
• Investigators: Principal Investigator: Helle J Christiansen, Msc., University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Prevention; Ergonomics; Physical exercise training; Surgeons; Microbreaks
• Additional Relevant MeSH Terms: Wounds and Injuries; Occupational Injuries
• Other Study ID Numbers: 20205100734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No