Accelerometer Measured Early Recovery After Prolapse Surgery

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Kaiser Permanente -- San Diego
RECRUITING
San Diego
University of California - San Diego
RECRUITING
San Diego
Illinois
University of Chicago
RECRUITING
Chicago
North Carolina
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
RECRUITING
Durham
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Rhode Island
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
RECRUITING
Providence
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 288
Treatments
No_intervention: Standard of Care
Active_comparator: Postoperative Exercise regimen
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego, RTI International, Duke University, University of Chicago, Kaiser Permanente, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Women and Infants Hospital of Rhode Island, University of Pennsylvania
Leads: NICHD Pelvic Floor Disorders Network

This content was sourced from clinicaltrials.gov