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

Occupational Exposure Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112106
• Other study ID #: 20205100734
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: August 2023
• Source: University of Aarhus
• Contact: Helle J Christiansen, Msc.
• Phone: +4550176163
• Email: hjchristiansen[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Occupational Exposure
• Occupational Injuries

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Working Environment Research Fund

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Working conditions	Surgical specialty, weekly workings hours as primary and assisting surgeon	Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Secondary	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)