Status:
RECRUITING
The AccelERate Trial
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborating Sponsors:
RTI International
University of California, San Diego
Conditions:
Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP)
Eligibility:
FEMALE
18-99 years
Phase:
NA
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...
Detailed Description
The AccelERate Trial is a single-masked RCT to determine if a prescribed early exercise regimen during the postoperative period in women undergoing minimally invasive surgery (MIS) for POP is associat...
Eligibility Criteria
Inclusion
- 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
- Inability or unwillingness to adhere to the exercise intervention
- Contraindication to medium-intensity exercise
- Comorbidities preventing physical activity
- Planned abdominal approach with laparotomy
Key Trial Info
Start Date :
October 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT07218016
Start Date
October 2 2025
End Date
December 31 2028
Last Update
December 30 2025
Active Locations (7)
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1
Kaiser Permanente -- San Diego
San Diego, California, United States, 92110
2
University of California - San Diego
San Diego, California, United States, 92121
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States, 27707