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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 10
- 主要终点
- Musculoskeletal pain intensity
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Investigator)
盲法说明
The investigator who performs the statistical analysis will be masked to group assignment, and analyses were performed blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgeon in gynecologic-, urologic, colorectal or abdominal surgery
- •Performs an average of four hours of surgery per week
排除标准
- •Own physician has advised against performing physical exercise training
研究组 & 干预措施
Intervention group
Surgeons
干预措施: Intelligent Physical Exercise Training (IPET) (Behavioral)
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.
结局指标
主要结局
Musculoskeletal pain intensity
时间窗: 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
次要结局
- Self-reported use of pain medicine(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)(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
- Self-reported physical resources(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
- Self-reported health(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
- Self-reported personal and work-related burnout(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
- Working conditions(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
- Self-reported work ability(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))
- Musculoskeletal pain frequency past 3 months(Assessed at baseline (pre-intervention), 12 weeks and 20 weeks (post-intervention))