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

NCT06525701 | Completed

• 1 other identifier: 218292
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Musculoskeletal Pain; Musculoskeletal Injury

Outcome Measures

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

  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.

  8-12 weeks

Secondary Outcomes (4)

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

  8-12 weeks

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

  8-12 weeks

• 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.

  8-12 weeks

• 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).

  8-12 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

Participants randomized to the exercise group will be asked to perform the SCORE workout two times each week for 4 weeks prior to their urogynecology rotation and for 4 weeks during the rotation.

Other: Execise Group; Other: Control Group

Control Group

ACTIVE COMPARATOR

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

Other: Execise Group; Other: Control Group

Interventions

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; Exercise Group

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.

Control Group; Exercise Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (26)

• Giagio S, Volpe G, Pillastrini P, Gasparre G, Frizziero A, Squizzato F. A Preventive Program for Work-related Musculoskeletal Disorders Among Surgeons: Outcomes of a Randomized Controlled Clinical Trial. Ann Surg. 2019 Dec;270(6):969-975. doi: 10.1097/SLA.0000000000003199.

  PMID: 30672801 BACKGROUND

• Allespach H, Sussman M, Bolanos J, Atri E, Schulman CI. Practice Longer and Stronger: Maximizing the Physical Well-Being of Surgical Residents with Targeted Ergonomics Training. J Surg Educ. 2020 Sep-Oct;77(5):1024-1027. doi: 10.1016/j.jsurg.2020.04.001. Epub 2020 Aug 4.

  PMID: 32763097 BACKGROUND

• Al Reshidi FS. Level of Physical Activity of Physicians Among Residency Training Program At Prince Sultan Military Medical City, Riyadh, KSA 2014. Int J Health Sci (Qassim). 2016 Jan;10(1):39-47. doi: 10.12816/0031215.

  PMID: 27004056 BACKGROUND

• Bertolaccini L, Viti A, Terzi A. Ergon-trial: ergonomic evaluation of single-port access versus three-port access video-assisted thoracic surgery. Surg Endosc. 2015 Oct;29(10):2934-40. doi: 10.1007/s00464-014-4024-6. Epub 2014 Dec 17.

  PMID: 25515979 BACKGROUND

• Cruz-Montecinos C, Bustamante A, Candia-Gonzalez M, Gonzalez-Bravo C, Gallardo-Molina P, Andersen LL, Calatayud J. Perceived physical exertion is a good indicator of neuromuscular fatigue for the core muscles. J Electromyogr Kinesiol. 2019 Dec;49:102360. doi: 10.1016/j.jelekin.2019.102360. Epub 2019 Sep 28.

  PMID: 31580987 BACKGROUND

• Choi SH, Kuchta K, Rojas A, Mehdi SA, Ramirez Barriga M, Hays S, Talamonti MS, Hogg ME. Residents perform better technically, have less stress and workload, and prefer robotic to laparoscopic technique during inanimate simulation. Surg Endosc. 2023 Sep;37(9):7230-7237. doi: 10.1007/s00464-023-10216-5. Epub 2023 Jul 3.

  PMID: 37395804 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Dairywala MI, Gupta S, Salna M, Nguyen TC. Surgeon Strength: Ergonomics and Strength Training in Cardiothoracic Surgery. Semin Thorac Cardiovasc Surg. 2022 Winter;34(4):1220-1229. doi: 10.1053/j.semtcvs.2021.09.015. Epub 2021 Sep 29.

  PMID: 34597795 BACKGROUND

• Friedrich J, Brakke R, Akuthota V, Sullivan W. Reliability and Practicality of the Core Score: Four Dynamic Core Stability Tests Performed in a Physician Office Setting. Clin J Sport Med. 2017 Jul;27(4):409-414. doi: 10.1097/JSM.0000000000000366.

  PMID: 28653966 BACKGROUND

• Henriksen A, Haugen Mikalsen M, Woldaregay AZ, Muzny M, Hartvigsen G, Hopstock LA, Grimsgaard S. Using Fitness Trackers and Smartwatches to Measure Physical Activity in Research: Analysis of Consumer Wrist-Worn Wearables. J Med Internet Res. 2018 Mar 22;20(3):e110. doi: 10.2196/jmir.9157.

  PMID: 29567635 BACKGROUND

• Jo D, Bilodeau M. Rating of perceived exertion (RPE) in studies of fatigue-induced postural control alterations in healthy adults: Scoping review of quantitative evidence. Gait Posture. 2021 Oct;90:167-178. doi: 10.1016/j.gaitpost.2021.08.015. Epub 2021 Aug 25.

  PMID: 34492503 BACKGROUND

• Keohane DM, McGillivary NA, Daly B. Physical activity levels and perceived barriers to exercise participation in Irish General Practitioners and General Practice trainees. Ir Med J. 2018 Feb 9;111(2):690.

  PMID: 29952439 BACKGROUND

• Kopkash K, Novak K, Murphy R, Deliere A, Kuchta K, Rabbitt S, Pesce C, Winchester D, Yao K. Improving the Breast Surgeon's Ergonomic Workload for Nipple-Sparing Mastectomies Using Exercise and Operating Room Positioning Protocol. Ann Surg Oncol. 2021 Oct;28(10):5698-5706. doi: 10.1245/s10434-021-10447-7. Epub 2021 Jul 27.

  PMID: 34318384 BACKGROUND

• Kromberg LS, Kildebro NV, Mortensen LQ, Amirian I, Rosenberg J. Microbreaks in Laparoscopic Appendectomy have No Effect on Surgeons' Performance and Well-being. J Surg Res. 2020 Jul;251:1-5. doi: 10.1016/j.jss.2020.01.007. Epub 2020 Feb 21.

  PMID: 32092608 BACKGROUND

• Lentz TA, Rhon DI, George SZ. Predicting Opioid Use, Increased Health Care Utilization and High Costs for Musculoskeletal Pain: What Factors Mediate Pain Intensity and Disability? J Pain. 2020 Jan-Feb;21(1-2):135-145. doi: 10.1016/j.jpain.2019.06.004. Epub 2019 Jun 13.

  PMID: 31201989 BACKGROUND

• Meltzer AJ, Hallbeck MS, Morrow MM, Lowndes BR, Davila VJ, Stone WM, Money SR. Measuring Ergonomic Risk in Operating Surgeons by Using Wearable Technology. JAMA Surg. 2020 May 1;155(5):444-446. doi: 10.1001/jamasurg.2019.6384.

  PMID: 32159745 BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.

  PMID: 22036893 BACKGROUND

• Parry DA, Oeppen RS, Amin MSA, Brennan PA. Could exercise improve mental health and cognitive skills for surgeons and other healthcare professionals? Br J Oral Maxillofac Surg. 2018 Jun;56(5):367-370. doi: 10.1016/j.bjoms.2018.03.005. Epub 2018 Apr 9.

  PMID: 29650472 BACKGROUND

• Rodrigues H, Cobucci R, Oliveira A, Cabral JV, Medeiros L, Gurgel K, Souza T, Goncalves AK. Burnout syndrome among medical residents: A systematic review and meta-analysis. PLoS One. 2018 Nov 12;13(11):e0206840. doi: 10.1371/journal.pone.0206840. eCollection 2018.

  PMID: 30418984 BACKGROUND

• Selvaraj CS, Abdullah N. Physically active primary care doctors are more likely to offer exercise counselling to patients with cardiovascular diseases: a cross-sectional study. BMC Prim Care. 2022 Mar 29;23(1):59. doi: 10.1186/s12875-022-01657-3.

  PMID: 35350999 BACKGROUND

• Stone AA, Broderick JE, Junghaenel DU, Schneider S, Schwartz JE. PROMIS fatigue, pain intensity, pain interference, pain behavior, physical function, depression, anxiety, and anger scales demonstrate ecological validity. J Clin Epidemiol. 2016 Jun;74:194-206. doi: 10.1016/j.jclinepi.2015.08.029. Epub 2015 Nov 25.

  PMID: 26628334 BACKGROUND

• Suija K, Pechter U, Maaroos J, Kalda R, Ratsep A, Oona M, Maaroos HI. Physical activity of Estonian family doctors and their counselling for a healthy lifestyle: a cross-sectional study. BMC Fam Pract. 2010 Jun 18;11:48. doi: 10.1186/1471-2296-11-48.

  PMID: 20565892 BACKGROUND

• Whittaker RL, Sonne MW, Potvin JR. Ratings of perceived fatigue predict fatigue induced declines in muscle strength during tasks with different distributions of effort and recovery. J Electromyogr Kinesiol. 2019 Aug;47:88-95. doi: 10.1016/j.jelekin.2019.05.012. Epub 2019 May 18.

  PMID: 31136944 BACKGROUND

• Winters JN, Sommer NZ, Romanelli MR, Marschik C, Hulcher L, Cutler BJ. Stretching and Strength Training to Improve Postural Ergonomics and Endurance in the Operating Room. Plast Reconstr Surg Glob Open. 2020 May 13;8(5):e2810. doi: 10.1097/GOX.0000000000002810. eCollection 2020 May.

  PMID: 33133890 BACKGROUND

• Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.

  PMID: 12861145 BACKGROUND

• Yurteri-Kaplan LA, Park AJ. Surgical Ergonomics and Preventing Work-Related Musculoskeletal Disorders. Obstet Gynecol. 2023 Mar 1;141(3):455-462. doi: 10.1097/AOG.0000000000005079. Epub 2023 Feb 2. No abstract available.

  PMID: 36735407 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marian Acevedo-Alvarez, MD

  Loyola Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The control group will not have an exercise regimen. The PI will be blinded to randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: The intervention group will complete a core workout lasting 20 minutes twice a week for 4 weeks

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 12, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)