Wrist activity tracking to guide early recovery after pelvic organ prolapse surgery
Accelerometer Measured Early Recovery After Prolapse Surgery
NA · NICHD Pelvic Floor Disorders Network · NCT07218016
This study will try giving women having pelvic organ prolapse surgery either usual postoperative advice or a guided early-exercise plan while tracking activity with a wrist accelerometer to see which group reaches "mostly recovered" sooner.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | NICHD Pelvic Floor Disorders Network (network) |
| Locations | 7 sites (San Diego, California and 6 other locations) |
| Trial ID | NCT07218016 on ClinicalTrials.gov |
What this trial studies
AccelERate is a single-masked randomized controlled study comparing a prescribed early exercise regimen to standard postoperative recommendations for women undergoing minimally invasive or vaginal surgery for pelvic organ prolapse. Participants will wear an accelerometer on the non-dominant wrist, complete a daily self-reported recovery questionnaire, and be randomly assigned to routine or exercise-focused postoperative instructions. The exercise arm is asked to perform about 30 minutes of medium-intensity activity daily, and the primary outcome is the number of days to report being "mostly recovered." The study will also collect performance-based tests and clinical assessments to compare objective activity data with patient-reported and clinical outcomes.
Who should consider this trial
Good fit: Ambulatory women with stage III or higher pelvic organ prolapse scheduled for laparoscopic, robotic, or vaginal reconstructive or obliterative surgery who can wear an accelerometer, use the study smartphone app, and are willing to follow the postoperative exercise instructions are ideal candidates.
Not a fit: Patients with contraindications to medium-intensity exercise, medical comorbidities that prevent physical activity, planned open abdominal surgery, or inability/unwillingness to wear the device or follow the regimen are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could help patients recover faster and return to normal activities sooner without worsening pelvic floor outcomes.
How similar studies have performed: Observational and smaller studies have suggested earlier resumption of activity may reduce pelvic floor symptoms, but this is among the first randomized trials using wrist accelerometer data to test a prescribed early-exercise regimen.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California and 6 other locations
- Kaiser Permanente -- San Diego — San Diego, California, United States (RECRUITING)
- University of California - San Diego — San Diego, California, United States (RECRUITING)
- University of Chicago — Chicago, Illinois, United States (RECRUITING)
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery — Providence, Rhode Island, United States (RECRUITING)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pelvic Organ Prolapse, Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse, Patient Education, accelerometer, Post-operative Recovery, recovery activities