Pelvic Organ Prolapse, Pelvic Organ Prolapse, Patient Education, Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
Conditions
Keywords
accelerometer, Pelvic Organ Prolapse (POP), Post-operative Recovery, recovery activities
Brief 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.
Detailed description
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.
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.
Sponsors
NICHD Pelvic Floor Disorders Network
RTI International
University of California, San Diego
University of Chicago
Duke University
Women and Infants Hospital of Rhode Island
University of Pennsylvania
Kaiser Permanente
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Status | From Day 3 post operation to 12 weeks post operation OR until participant achieves Mostly Recovered Status, whichever occurs first. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Exercise | From baseline to 6 weeks post operation. | To measure adherence to a prescribed early exercise regimen using accelerometry for 6 weeks postoperatively and to determine if there is a difference in activity based on accelerometer data through 6 weeks postoperatively between women in the prescribed exercise regimen group versus those in the standard postoperative activity instruction group. |
| Change From Baseline PFDI-20 Score | From baseline to 12 weeks post operation | 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). |
| Change From Baseline PFIQ-7 Score | From baseline to 12 weeks post operation | 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). |
| PGI-I Score | From 12 weeks post operation to 1 year post operation | 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). |
| Change From Baseline AAS Score | From baseline to 12 weeks post operation | 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). |
| Change From Baseline NRS Score | From baseline to 12 weeks post operation | 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. |
| Change From Baseline SSCT Score | From baseline to 12 weeks post operation | 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. |
| DRS Score | From 12 weeks post operation to 1 year post operation. | 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. |
| Anatomic Recovery | From baseline to 12 weeks following operation | 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). |
Countries
United States
Outcome results
None listed