Accelerometer Measured Early Recovery After Prolapse Surgery

NCT07218016 | Recruiting DMC

• 8 other identifiers: PFDN-34P01_1UG1HD069013UG1HD054214UG1HD041267UG1HD054241UG1HD110057UG1HD069010U24HD069031
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 7

Brief Summary

The AccelERate study will evaluate the physical recovery of patients who have undergone Pelvic Organ Prolapse (POP) surgery. This will be evaluated via a self-reported recovery questionnaire completed daily. Participants will wear an accelerometer device on their non-dominant wrist and be given either routine or exercise-focused postoperative instructions. The primary outcome will be a comparison of the number of days needed to reach self-reported "mostly recovered" status between randomly assigned instruction groups.

Conditions

Pelvic Organ Prolapse (POP); Pelvic Organ Prolapse Vaginal Surgery; Pelvic Organ Prolapse; Pelvic Organ Prolapse, Patient Education

Keywords

accelerometer; Pelvic Organ Prolapse (POP); Post-operative Recovery; recovery activities

Outcome Measures

Primary Outcomes (1)

• Recovery Status

  A participant will be considered "mostly recovered" if they report feeling "mostly" or "completely" recovered on 2 consecutive daily self-report occasions, allowing for skipped days. The primary outcome will be number of days since surgery at which the participant first reports feeling mostly recovered, provided they confirm that status on the next consecutive occasion.

  From Day 3 post operation to 12 weeks post operation OR until participant achieves Mostly Recovered Status, whichever occurs first.

Secondary Outcomes (9)

• Adherence to Exercise

  From baseline to 6 weeks post operation.

• Change From Baseline PFDI-20 Score

  From baseline to 12 weeks post operation

• Change From Baseline PFIQ-7 Score

  From baseline to 12 weeks post operation

• PGI-I Score

  From 12 weeks post operation to 1 year post operation

• Change From Baseline AAS Score

  From baseline to 12 weeks post operation

Other Outcomes (6)

• Longitudinal Outcomes - Change From Baseline PFDI-20 Score

  Baseline to 1 year post-operation

• Longitudinal Outcomes - Change From Baseline PFIQ-7 Score

  Baseline to 1 year post-operation

• Longitudinal Outcomes - Change From Baseline AAS Score

  Baseline to 1 year post-operation

Study Arms (2)

Standard of Care

NO INTERVENTION

Postoperative Exercise regimen

ACTIVE COMPARATOR

Behavioral: Postoperative Exercise regimen

Interventions

Postoperative Exercise regimen BEHAVIORAL

The intervention arm will be instructed to perform 30 minutes of medium intensity exercise (vigorous enough to cause shortness of breath, but light enough to be able to maintain a conversation) starting on postoperative day 3 and continuing at least 5 times weekly for 6 weeks. Participants in the intervention group will be allowed to select their preferred physical activity, and the activity will be performed without supervision. Participants in the control group will be given typical postoperative instructions with gradual resumption of activity.

Postoperative Exercise regimen

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided written informed consent
• Ambulatory women undergoing laparoscopic, robotic, or vaginal reconstructive or obliterative surgery for apical prolapse
• POP-Q \>= Stage III
• Willing to participate in a postoperative exercise regimen
• Able to read and consent in English or Spanish
• Willing and able to wear an accelerometer prior to and after surgery (including agreeing to the terms of service), use an electronic data capture software, and record daily events
• Willing and able to install and use study-related smartphone app(s)
• Anticipated hospital discharge \<= postoperative day 1

You may not qualify if:

• Inability or unwillingness to adhere to the exercise intervention
• Contraindication to medium-intensity exercise
• Comorbidities preventing physical activity
• Planned abdominal approach with laparotomy

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• RTI International: collaborator
• University of Pennsylvania: collaborator
• Kaiser Permanente: collaborator
• University of California, San Diego: collaborator
• University of Chicago: collaborator
• Duke University: collaborator
• Women and Infants Hospital of Rhode Island: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (7)

Kaiser Permanente -- San Diego

San Diego, California, 92110, United States

RECRUITING

University of California - San Diego

San Diego, California, 92121, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, 27707, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery

Providence, Rhode Island, 02903, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

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Related Links

• Physical Activity Guidelines for Americans

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Plan to submit full study dataset after the study is completed.
• Access Criteria: Access is managed by DASH.

Locations

US (7)