Occupational InjuriesNCT06112106
The Effect of Intelligent Exercise and Ergonomic Recommendations on Surgeon Musculoskeletal Discomfort
A study testing Intelligent Physical Exercise Training (IPET) in people with Occupational Injuries and Occupational Exposure, run by University of Aarhus at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Injuries, Occupational Exposure
- What is being tested?
- Intelligent Physical Exercise Training (IPET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 13 Dec 2023to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgeon in gynecologic-, urologic, colorectal or abdominal surgery
- Performs an average of four hours of surgery per week
Who cannot join
- Own physician has advised against performing physical exercise training
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Denmark5 sites
Aarhus University
Aarhus, 5500
Gødstrup Regional Hospital
Gødstrup
Odense University Hospital
Odense
Randers Regional Hospital
Randers
Sygehus Lillebælt, Vejle
Vejle
United States2 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
Mayo Clinic
Rochester, Minnesota, 55902
About this study
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.
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).
Read the 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.
- Conditions
- Occupational Injuries, Occupational Exposure
- Being tested
- Intelligent Physical Exercise Training (IPET)
- Keywords
- Ergonomics, Physical exercise training, Prevention, Rehabilitation, Microbreaks, Surgeons
- Medical subject headings
- Occupational Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Physical Exercise Training (IPET)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Intelligent Physical Exercise Training (IPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Secondary outcomes (8)
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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"
Measured: 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.
Measured: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Working conditions
Surgical specialty, weekly workings hours as primary and assisting surgeon
Measured: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
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)
Measured: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start13 Dec 2023
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational InjuriesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Working Environment Research Fund
- Responsible party
- Sponsor
- Investigators
- Helle J Christiansen, Msc., Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112106
- Sponsor's protocol ID
- 20205100734
- Status last verified
- Aug 2024
- First submitted
- 4 Oct 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41388556
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06112106
- Acronym / sponsor ID
- 20205100734
- Conditions
- Occupational Injuries, Occupational Exposure
- Keywords
- Ergonomics, Physical exercise training, Prevention, Rehabilitation, Microbreaks, Surgeons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Working Environment Research Fund
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Intelligent Physical Exercise Training (IPET)Surgeons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgeon in gynecologic-, urologic, colorectal or abdominal surgery
- Performs an average of four hours of surgery per week
Key exclusion criteria (1 listed)
- Own physician has advised against performing physical exercise training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
Musculoskeletal pain intensity
Time frame: 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 in neck, shoulders, elbows/arms, wrists/hands, upper back, lower back, hips, knees, ankle/feet
8 secondary outcomes
Self-reported use of pain medicine
Time frame: 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)
Time frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported physical resources
Time frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported health
Time frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported personal and work-related burnout
Time frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Self-reported work ability
Time frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Working conditions
Time frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Musculoskeletal pain frequency past 3 months
Time frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 41388556Christiansen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle J Christiansen, Msc. principal investigator
University of Aarhus
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Physical Exercise Training (IPET) in people with Occupational Injuries and Occupational Exposure, run by University of Aarhus at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal pain intensity (time frame: Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06112106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.