Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
288 participants
INTERVENTIONAL
2025-10-02
2028-12-31
Brief Summary
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Detailed Description
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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 (modeled after recent surgical postoperative physical activity studies). The amount of physical activity is in line with the Center for Disease Control and Prevention (CDC) guidelines and has been utilized in previous postoperative exercise studies. 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 liberalized postoperative instructions with gradual resumption of activity. The decision to allow women to liberally resume activity following surgery was informed by previous postoperative activity recommendation studies in women undergoing prolapse surgery.
All participants will undergo a baseline surgical evaluation including a POP-Q exam and PFDI-20 and PFIQ-7, complete AAS and record their physical activity for one week. Baseline physical activity data will include objective, quantitative measurement of movement using the accelerometer during waking hours for seven days (not necessarily consecutive days), and 30-second sit to stand test (STS).
Following surgery on postoperative day 3, participants will resume wearing an accelerometer continuously during waking hours. Those randomized to prescriptive exercise arm will be instructed to complete 30 minutes of medium intensity exercise as recommended by CDC and log their activity and percent recovery. If participants cannot complete the exercises, they will be asked to explain why (pain, nausea, catheter in place, logistical constraints, time constraints). Participants will be queried every day via the mobile research app as to the recovery they feel they have achieved. When a participant records "mostly" or "completely" recovered on 2-consecutive occasions (allowing for skipped days), she will stop receiving alerts. The primary outcome will be number of days since surgery at which the participant first reports being mostly recovered, provided she confirms that status on the next consecutive occasion (allowing for skipped days).
Postoperative study data will be collected remotely from participants via the app until 12-weeks. Accelerometer data will be downloaded from the devices 2-, 6-, and 12-week visits. At 12 weeks and 1 year, participants will undergo an in-office evaluation (including examination) assessing anatomic and functional outcomes with a surgeon masked to study assignment. They will also complete the AAS, PFDI-20, PFIQ-7, Decisional Regret Scale, NRS and PGI-I. At the baseline, 12-week, and 1-year visits, research staff will collect the self-administered activity questionnaires. At all study visits, research staff will record any adverse events.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard of Care
No interventions assigned to this group
Postoperative Exercise regimen
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindication to medium-intensity exercise
* Comorbidities preventing physical activity
* Planned abdominal approach with laparotomy
18 Years
99 Years
FEMALE
No
Sponsors
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RTI International
OTHER
University of California, San Diego
OTHER
University of Chicago
OTHER
Duke University
OTHER
Women and Infants Hospital of Rhode Island
OTHER
University of Pennsylvania
OTHER
Kaiser Permanente
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Pelvic Floor Disorders Network
NETWORK
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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Gisselle Zazueta-Damian
Role: primary
Kyle Herrala
Role: primary
Jinxuan (Rowena) Shi
Role: primary
Stephanie Yu
Role: primary
Zandra Kennedy
Role: primary
Madeline Malloy
Role: primary
Agnes Burris
Role: primary
References
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Related Links
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Physical Activity Guidelines for Americans
Other Identifiers
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PFDN-34P01_1
Identifier Type: -
Identifier Source: org_study_id