Accelerometer Measured Early Recovery After Prolapse Surgery

Part of paid clinical trials in San Diego, California.

Sponsor
NICHD Pelvic Floor Disorders Network
Study ID
NCT07218016
Status
Recruiting
Apply to this trial

Conditions

  • Pelvic Organ Prolapse
  • Pelvic Organ Prolapse (POP)
  • Pelvic Organ Prolapse Vaginal Surgery
  • Pelvic Organ Prolapse, Patient Education

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Postoperative Exercise regimen — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 2, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care
  • Active Comparator: Postoperative Exercise regimen

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. ]

Locations (7)

FacilityCityStateZIPSite coordinators
Kaiser Permanente -- San DiegoSan DiegoCalifornia92110
Gisselle Zazueta-Damian
[email protected]
619- 221-6274
University of California - San DiegoSan DiegoCalifornia92121
Kyle Herrala
[email protected]
858-657-6827
University of ChicagoChicagoIllinois60637
Jinxuan (Rowena) Shi
[email protected]
872-724-0774
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic SurgeryDurhamNorth Carolina27707
Stephanie Yu
[email protected]
(919) 401-1015
University of PennsylvaniaPhiladelphiaPennsylvania19104
Zandra Kennedy
[email protected]
(215) 615-6569
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic SurgeryProvidenceRhode Island02903
Madeline Malloy
[email protected]
(401) 430-8228
University of Texas Southwestern Medical CenterDallasTexas75390
Agnes Burris
[email protected]
(214) 645-3833
David Rahn, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By research site
Kaiser Permanente -- San Diego· San Diego, CAUniversity of California - San Diego· San Diego, CAUniversity of Chicago· Chicago, ILDuke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery· Durham, NCUniversity of Pennsylvania· Philadelphia, PABrown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery· Providence, RI

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