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

Sponsor
University of Aarhus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06112106
Collaborator
The Working Environment Research Fund (Other)
170
1
2
16
10.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intelligent Physical Exercise Training (IPET)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
The investigator who performs the statistical analysis will be masked to group assignment.
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Musculoskeletal pain intensity [Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)]

    Pain intensity on a 11-point Likert scale (0= no pain, 10= most intense pain) the past 3 months and last 7 days

  2. Musculoskeletal pain frequency past 3 months [Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)]

    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)

Secondary Outcome Measures

  1. 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)]

    Accumulated physical activity during a regular week (hours/minutes). Answer categories: less than 30 min., 30-90 min., 90-149 min., 150-299 min., 300 min. or more.

  2. Self-reported physical resources [Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)]

    Rating own physical resources (cardiorespiratory fitness, strength, endurance, flexibility, balance) compared to peers on a Likert scale (0= poor, 10= good).

  3. Self-reported general health [Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)]

    On a five-point Likert scale (0= excellent, 5= poor)

  4. Self-reported workability [Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)]

    Indication of whether physical health issues affect work performance on a 11-point Likert scale (0= health issues did not affect my work ability, 10= health issues prevented me from working entirely).

  5. Self-reported workability in every day life [Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)]

    Indication of whether physical health issues affect performance of activities of daily living on a 11-point Likert scale (0= health issues did not affect activities of daily life, 10= health issues prevented me from performing activities of daily life).

  6. Self-reported sickness absenteeism [Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)]

    Number of work days missed for the past 3 months due to musculoskeletal pain/discomfort

  7. Self-reported productivity [Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)]

    On a 11-point Likert scale (0= musculoskeletal pain has not affected work productivity, 10= musculoskeletal pain has prevented me from working entirely).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aarhus University Aarhus Denmark 5500

Sponsors and Collaborators

  • University of Aarhus
  • The Working Environment Research Fund

Investigators

  • Principal Investigator: Helle J Christiansen, Msc., University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT06112106
Other Study ID Numbers:
  • 20205100734
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2023