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

NCT ID: NCT06112106

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Occupational Injuries Occupational Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The investigator who performs the statistical analysis will be masked to group assignment.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Surgeons

Group Type EXPERIMENTAL

Intelligent Physical Exercise Training (IPET)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Working Environment Research Fund

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helle J Christiansen, Msc.

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Aarhus University

Aarhus, , Denmark

Site Status

Gødstrup Regional Hospital

Gødstrup, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Randers Regional Hospital

Randers, , Denmark

Site Status

Sygehus Lillebælt, Vejle

Vejle, , Denmark

Site Status

Countries

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United States Denmark

Other Identifiers

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20205100734

Identifier Type: -

Identifier Source: org_study_id

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