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

September 2, 2025 updated by: Marian G. Acevedo Alvarez, Loyola University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Group
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
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.
Other: Control Group
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.
Active Comparator: Control Group
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
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.
Other: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8-12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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).
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").
8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loyola University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marian Acevedo-Alvarez, MD, Loyola Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 218292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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