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Completed

NCT Number: NCT06525701

Surgeon Core-strengthening Program as a Modifier for Exertion Associated With Vaginal Surgery

Work-related musculoskeletal pain and injury is a growing concern in surgery. Vaginal surgery has unique ergonomic risks, but no studies have addressed the potential for an exercise regimen to reduce physical strain by vaginal surgeons

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Key information

Conditions

Musculoskeletal Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Injury Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

Surgical ergonomics is a burgeoning field, spurred by the recognition of the high prevalence of work-related musculoskeletal pain and injury in practicing surgeons including obstetrician/gynecologists. Surgery is often a demanding physical task, and the muscles and joints that are stressed vary by the surgical approach. Vaginal surgery has unique ergonomic challenges, particularly for assistants who may need to laterally bend their torsos to visualize the surgical field while still holding retractors. This is often a compromising physical position for the back, the shoulders, and sometimes the neck which increases the risk of acute or chronic musculoskeletal injury. The risk of injury can be thought of as a discrepancy between the demands of the task and the individual's physical capabilities. Surgeons' injury risk may be decreased if their physical capabilities can be improved through exercise. Most existing publications on surgical ergonomics have focused on raising awareness and on environmental changes such as optimizing surgeon posture during the case or introducing micro-breaks and stretching. Few publications have assessed a structured exercise program with the goal of decreasing surgeon pain or fatigue during and after surgery. To our knowledge, no studies have addressed this in vaginal surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participant: ob/gyn resident or urology resident or urogyn fellow or urogyn attending Case: vaginal prolapse surgery >2 hours in length

Exclusion criteria

Participant:

  • Actively in physical therapy
  • Joint surgery or joint injury within last 12 weeks
  • Pregnant
  • Less than 6 weeks postpartum

Case:

  • Vaginal surgery <2 hours in length
  • Non-prolapse vaginal surgery

Treatment and study plan

Execise Group

Other

SCORE workout: eight exercises done sequentially: bicycles, balancing dog, windshield wipers, three-point plank, kayaker, super push-ups, bridge, and side plank. These workouts are modified from the core regimen recommended by Steve House and Scott Johnston in their book Training for the New Alpinism: A Manual for the Climber as Athlete (House 2014). Each exercise is done until fatigue: when the individual is no longer able to complete the exercise with good form. The participant then rests for approximately thirty to sixty seconds before beginning the next exercise. Passive stretching can be performed during the rest periods. The workout is complete at twenty minutes. Those individuals who complete all eight exercises in less than twenty minutes begin again with the first exercise (bicycles) and continue until reaching twenty minutes. The workout is thus adaptive-seamlessly increasing in repetitions as an individual's strength and endurance increase.

Control Group

Other

No additional exercises or tasks are requested of control participants. Control group participants will perform or not perform exercise as they otherwise would outside of the study.

Primary outcomes

  1. The effect of a core-strengthening program on surgeons' physical exertion during and after vaginal prolapse surgery using the Borg rating of perceived exertion (Borg CR10). To determine the effect of a core-strengthening program on surgeon

    Time frame: 8-12 weeks

    The effect of a core-strengthening program on surgeons' physical exertion during and after vaginal prolapse surgery as measured by the Borg Category Ratio (CR-10). The Borg Category Ratio scale is a self-reported tool that describes level of exertion and ranges from 0-10 where larger numbers represent greater exertion.

Secondary outcomes

  1. To describe the baseline core strength in a population of vaginal surgeons using the validated Core Score

    Time frame: 8-12 weeks

    • Core Score: The Core Score ranges from 0-12 where higher scores indicate better performance on core-related exercises.

  2. To describe the execise habits and activity level in a populationa of vaginal surgeons using activity tracker data and the International Physical Activity Questionnaire.

    Time frame: 8-12 weeks

    • International Physical Activity Questionnaire-Short Form (IPAQ-SF): Participant responses on time spent walking, doing moderate exercise, and doing vigorous exercise are first compared to a rubric for the categorical score. The categorical score ranges 1-3 where 1 is "inactive" and 3 is "health-enhancing physical activity". Participant responses are also used to calculate the weekly metabolic equivalent (MET) minutes where a higher number indicates more time spent being physically active.

  3. To measure the effect of a core-strengthening program on surgeons' pain during and after vaginal prolapse surgery using the PROMIS Pain Intensity-Short Form (PI-SF) and body diagrams.

    Time frame: 8-12 weeks

    • PROMIS Pain Intensity-Short Form (PI-SF): The raw score ranges from 3-15 where higher scores indicate more pain. Raw scores are converted to t-scores where a t-score of 50 represents the average in the United States population.

  4. To measure objective and subjective change in core strength after completion of the core-strengthening program using the Core Score and Patient Global Impression of Improvement (PGI-I).

    Time frame: 8-12 weeks

    • Patient Global Impression of Improvement (PGI-I): Lower Patient Global Impression of Improvement scores indicate more improvement. PGI-I ranges from 1 ("very much better") to 7 ("very much worse").

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

Surgeon Core-strengthening Program as a Modifier for Exertion Associated With Vaginal Surgery: the SCORE Randomized Controlled Trial

Acronym: SCORE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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