RecruitingNot ApplicableNCT07218016

Accelerometer Measured Early Recovery After Prolapse Surgery


Sponsor

NICHD Pelvic Floor Disorders Network

Enrollment

288 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Inclusion Criteria8

  • 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 Criteria4

  • 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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Interventions

BEHAVIORALPostoperative 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.


Locations(7)

Kaiser Permanente -- San Diego

San Diego, California, United States

University of California - San Diego

San Diego, California, United States

University of Chicago

Chicago, Illinois, United States

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT07218016


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