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.

The AccelERate Trial

Pelvic Organ Prolapse

Pelvic Organ Prolapse (POP)

Pelvic Organ Prolapse Vaginal Surgery

Pelvic Organ Prolapse, Patient Education

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 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.

Postoperative Exercise regimen

Accelerometer Measured Early Recovery After Prolapse Surgery

A participant will be considered "mostly recovered" if they report feeling "mostly" or "completely" recovered on 2 consecutive daily self-report occasions, allowing for skipped days. The primary outcome will be number of days since surgery at which the participant first reports feeling mostly recovered, provided they confirm that status on the next consecutive occasion.

To measure adherence to a prescribed early exercise regimen using accelerometry for 12 weeks postoperatively and to determine if there is a difference in activity based on accelerometer data at 2, 6, and 12 weeks postoperatively between women in the prescribed exercise regimen group versus those in the standard postoperative activity instruction group.

The Pelvic Floor Distress Inventory (PFDI-20) is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an Overall scale (range: 0-300) comprised of 3 sub-scales:

1. Pelvic Organ Prolapse Distress Inventory (range: 0-100),
2. Colorectal Anal Distress Inventory (range: 0-100) and,
3. Urinary Distress Inventory (range: 0-100). The range of responses for all questions is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Subscale scores are calculated by multiplying the mean value of all questions answered by 25 for the subscale. The range of score for each subscale is: 0-100 with 0 (least distress) to 100 (most distress). The PFDI-20 is calculated as the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFDI-20 scale. Change from baseline = (Week[2,6,12] Score - Baseline Score).

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of an overall score (range 0-300), 3 subscales (7 questions each): the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on all questions is 0-3 with (0) Not at all ... (3), Quite a bit. Subscale scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of scores for each subscale is: 0-100 with 0 (least negative impact) to 100 (most negative impact). The PFI-7Q is the sum of the three subscales. Lower scores indicate better function / fewer symptoms for the PFIQ-7 score. Change from baseline = (Week[2,6,12] - Baseline Score).

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived condition improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse).

The Activity Assessment Scale (AAS) is a standardized measure of functional activity. The score ranges from 0 to 100 with higher scores indicating greater functional activity. Change from baseline = (Week[2,6,12] - Baseline Score).

The Numeric Rating Scale (NRS) is a one-question validated patient-reported measure that quantifies the intensity of a specific symptom or experience on a numeric scale, from 0 (no pain) to 10 (worst pain imaginable). Higher scores are worse.

The 30-Second Sit to Stand Chair Test (SSCT) is a validated measure of lower body strength and endurance used to assess fall risk and functional ability in adults, especially older adults. The number of times a participant is able of going from sitting to standing is recorded and compared to normalized scores.

The Decisional Regret Scale (DRS) is a standardized assessment of treatment satisfaction. It asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). Higher scores are worse.

Pelvic Organ Prolapse Quantification System (POP-Q) sites (Aa, Ba, C, D, Ap, Bp) are measured in centimeters relative to the hymenal plane. Measurements include genital hiatus (GH), perineal body (PB), and total vaginal length (TVL). This outcome represents the change in measurements. Evaluated as change from baseline. Change from baseline = (Week[12] - Baseline Score).

The AccelERate Trial

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

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