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Accelerometer Measured Early Recovery After Prolapse Surgery

RecruitingNAAges 18 Years - 99 YearsFemaleNICHD Pelvic Floor Disorders Network
NCT07218016 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Inability or unwillingness to adhere to the exercise intervention * Contraindication to medium-intensity exercise * Comorbidities preventing physical activity * Planned abdominal approach with laparotomy
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What it tests

  • Postoperative Exercise regimen
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Where

7 sites
Kaiser Permanente -- San Diego
San Diego, United States
University of California - San Diego
San Diego, United States
University of Chicago
Chicago, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, United States
University of Pennsylvania
Philadelphia, United States
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, United States
University of Texas Southwestern Medical Center
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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