AccelERate (AccelERate)

Investigating Recovery After Pelvic Surgery

Recruiting
18 years - 99 years
Female
Phase N/A
288 participants needed
1 Location

Brief description of study

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.

Detailed description of study

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 associated with quicker recovery compared to standard recommendations for postoperative activities. AccelERate will go beyond existing research and be the first to implement and quantitatively evaluate with accelerometer data a postoperative exercise regimen and its effects on recovery and pelvic floor symptoms. We will quantify postoperative activity as well as recovery using self-report, performance-based testing, and objective medical assessment. In this way, we will rigorously investigate the regimen's effect on postoperative recovery and pelvic floor outcomes. Given prior findings that women who resume physical activity early in the postoperative period report fewer pelvic floor symptoms than women restricted from activity, we hypothesize that an intervention designed to encourage physical activity in the postoperative period may even further improve recovery without impacting short- or long-term functional and anatomic outcomes. Thus, AccelERate has the potential to transform care for women with POP who will no longer be required to alter their lifestyle and the activities for which they are having surgery.

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 at 2- and 6-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 baseline, research staff will collect the self-administered activity questionnaire. At all study visits, research staff will record any adverse events.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pelvic Organ Prolapse, Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse, Patient Education
  • Age: 18 years - 99 years
  • Gender: Female

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

This study investigates the recovery process in women who have undergone Pelvic Organ Prolapse (POP) surgery. Participants will be evaluated using a self-reported recovery questionnaire and will wear an accelerometer on their wrist to monitor activity levels.

The study evaluates whether a prescribed exercise regimen after surgery can lead to quicker recovery compared to standard postoperative instructions. It will assess recovery and pelvic floor symptoms using self-reports, performance-based testing, and medical assessments.

  • Who can participate: Women who are ambulatory and undergoing specific types of surgery for apical prolapse can participate. They must be willing to engage in a postoperative exercise regimen.
  • Study details: Participants will wear an accelerometer and complete daily recovery questionnaires. Some will follow an exercise routine, while others will receive standard postoperative instructions. A placebo is not involved in this study.
  • Study timelines and visits: The study will last 12 weeks. The study requires 2 visits.
Updated on 27 Apr 2026. Study ID: 25-1224

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