RecruitingNot Applicable

Accelerometer Measured Early Recovery After Prolapse Surgery

United States288 participantsStarted 2025-10-02

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recovery Status

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

Trial details

NCT IDNCT07218016

SponsorNICHD Pelvic Floor Disorders Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-06-30