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| Name | Class |
|---|---|
| The Working Environment Research Fund | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intelligent Physical Exercise Training (IPET) | 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helle J Christiansen, Msc. | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41388556 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2025 | Dec 16, 2025 |
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The investigator who performs the statistical analysis will be masked to group assignment, and analyses were performed blinded to group allocation.
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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) |
| 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) |
| Rochester |
| Minnesota |
| 55902 |
| United States |
| Aarhus University | Aarhus | 5500 | Denmark |
| Gødstrup Regional Hospital | Gødstrup | Denmark |
| Odense University Hospital | Odense | Denmark |
| Randers Regional Hospital | Randers | Denmark |
| Sygehus Lillebælt, Vejle | Vejle | Denmark |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D060051 | Occupational Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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