Recruiting

Observational Study

Sponsor:

NICHD Pelvic Floor Disorders Network

Code:

NCT07218016

Conditions

Pelvic Organ Prolapse

Pelvic Organ Prolapse (POP)

Pelvic Organ Prolapse Vaginal Surgery

Pelvic Organ Prolapse, Patient Education

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Postoperative Exercise regimen

Study Details

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 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.

Conditions

Pelvic Organ Prolapse

Pelvic Organ Prolapse (POP)

Pelvic Organ Prolapse Vaginal Surgery

Pelvic Organ Prolapse, Patient Education

Study ID

NCT07218016

Start date

Oct 2, 2025

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

active comparator: Postoperative Exercise regimen

Interventions

Postoperative Exercise regimen

The intervention arm will be instructed to perform 30 minutes of medium intensity exercise (vigorous enough to cause shortness of breath, but light enough to be able to maintain a conversation) starting on postoperative day 3 and continuing at least 5 times weekly for 6 weeks. Participants in the intervention group will be allowed to select their preferred physical activity, and the activity will be performed without supervision. Participants in the control group will be given typical postoperative instructions with gradual resumption of activity.

Primary outcome measure

  • Recovery Status [ Time Frame: From Day 3 post operation to 12 weeks post operation OR until participant achieves Mostly Recovered Status, whichever occurs first. ]

Central Contacts and Locations

Locations

Kaiser Permanente -- San Diego

Recruiting

San Diego, California, United States, 92110

Contacts

Gisselle Zazueta-Damian

619- 221-6274Gisselle.Zazueta-Damian@kp.org

University of California - San Diego

Recruiting

San Diego, California, United States, 92121

Contacts

Kyle Herrala

858-657-6827UrogynRSCH@ucsd.edu

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jinxuan (Rowena) Shi

872-724-0774jinxuan.shi@bsd.uchicago.edu

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Recruiting

Durham, North Carolina, United States, 27707

Contacts

Stephanie Yu

(919) 401-1015stephanie.yu@duke.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Zandra Kennedy

(215) 615-6569zandra.kennedy@pennmedicine.upenn.edu

Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Madeline Malloy

(401) 430-8228MMMalloy@wihri.org

More Information

Sponsor

NICHD Pelvic Floor Disorders Network

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • accelerometer
  • Pelvic Organ Prolapse (POP)
  • Post-operative Recovery
  • recovery activities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NICHD Pelvic Floor Disorders Network on 2026-04-27.