Clinical trial NCT06525701: Surgeon Core-strengthening Program as a Modifier for Exertion Associated With Vaginal Surgery
Official title: Surgeon Core-strengthening Program as a Modifier for Exertion Associated With Vaginal Surgery: the SCORE Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Pain
Musculoskeletal Injury
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will complete a core workout lasting 20 minutes twice a week for 4 weeks
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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:

1. Actively in physical therapy
2. Joint surgery or joint injury within last 12 weeks
3. Pregnant
4. Less than 6 weeks postpartum

Case:

1. Vaginal surgery \<2 hours in length
2. Non-prolapse vaginal surgery

Primary outcomes:
measure: 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
timeFrame: 8-12 weeks
Secondary outcomes:
measure: To describe the baseline core strength in a population of vaginal surgeons using the validated Core Score
timeFrame: 8-12 weeks
measure: To describe the execise habits and activity level in a populationa of vaginal surgeons using activity tracker data and the International Physical Activity Questionnaire.
timeFrame: 8-12 weeks
measure: 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.
timeFrame: 8-12 weeks
measure: 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).
timeFrame: 8-12 weeks
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola Medical Center
name: Marian Acevedo-Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.