Pelvic Organ ProlapseAccelERateNCT07218016
Accelerometer Measured Early Recovery After Prolapse Surgery
A study testing Postoperative Exercise regimen in people with Pelvic Organ Prolapse and Pelvic Organ Prolapse (POP), run by NICHD Pelvic Floor Disorders Network at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
- What is being tested?
- Postoperative Exercise regimen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Oct 2025to 31 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability or unwillingness to adhere to the exercise intervention
- Contraindication to medium-intensity exercise
- Comorbidities preventing physical activity
- Planned abdominal approach with laparotomy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jinxuan (Rowena) Shi, 872-724-0774, jinxuan.shi@bsd.uchicago.edu
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Agnes Burris, (214) 645-3833, agnes.burris@UTSouthwestern.edu
David Rahn, MD
- Recruiting
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707
Stephanie Yu, (919) 401-1015, stephanie.yu@duke.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Zandra Kennedy, (215) 615-6569, zandra.kennedy@pennmedicine.upenn.edu
- Recruiting
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, Rhode Island, 02903
Madeline Malloy, (401) 430-8228, MMMalloy@wihri.org
- Recruiting
Kaiser Permanente -- San Diego
San Diego, California, 92110
Gisselle Zazueta-Damian, 619- 221-6274, Gisselle.Zazueta-Damian@kp.org
- Recruiting
University of California - San Diego
San Diego, California, 92121
Kyle Herrala, 858-657-6827, UrogynRSCH@ucsd.edu
About this 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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse, Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse, Patient Education
- Being tested
- Postoperative Exercise regimen
- Keywords
- accelerometer, Pelvic Organ Prolapse (POP), Post-operative Recovery, recovery activities
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Exercise regimenBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Not described |
| Postoperative Exercise regimen | Active comparator | Not described Receives: Behavioral: Postoperative Exercise regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Status
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.
Measured: From Day 3 post operation to 12 weeks post operation OR until participant achieves Mostly Recovered Status, whichever occurs first.
Secondary outcomes (9)
Adherence to Exercise
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.
Measured: From baseline to 6 weeks post operation.
Change From Baseline PFDI-20 Score
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:
- Pelvic Organ Prolapse Distress Inventory (range: 0-100),
- Colorectal Anal Distress Inventory (range: 0-100) and,
- 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).
Measured: From baseline to 12 weeks post operation
Change From Baseline PFIQ-7 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).
Measured: From baseline to 12 weeks post operation
PGI-I 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).
Measured: From 12 weeks post operation to 1 year post operation
Change From Baseline AAS Score
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).
Measured: From baseline to 12 weeks post operation
Change From Baseline NRS 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.
Measured: From baseline to 12 weeks post operation
Change From Baseline SSCT Score
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.
Measured: From baseline to 12 weeks post operation
DRS Score
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.
Measured: From 12 weeks post operation to 1 year post operation.
Anatomic Recovery
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).
Measured: From baseline to 12 weeks following operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start2 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Sponsor type
- Research network
- Collaborators
- 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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218016
- Sponsor's protocol ID
- PFDN-34P01_1
- Other IDs
- UG1HD069013, UG1HD054214, UG1HD041267, UG1HD054241, UG1HD110057, UG1HD069010, U24HD069031
- Acronym
- AccelERate
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be made available through DASH
Publications
Onerup A, Andersson J, Angenete E, Bock D, Borjesson M, Ehrencrona C, Fagevik Olsen M, Larsson PA, de la Croix H, Wedin A, Haglind E. Effect of Short-term Homebased Pre- and Postoperative Exercise on Recovery After Colorectal Cancer Surgery (PHYSSURG-C): A Randomized Clinical Trial. Ann Surg. 2022 Mar 1;275(3):448-455. doi: 10.1097/SLA.0000000000004901.
PubMed 33843798Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
PubMed 8694033Sung VW, Kauffman N, Raker CA, Myers DL, Clark MA. Validation of decision-making outcomes for female pelvic floor disorders. Am J Obstet Gynecol. 2008 May;198(5):575.e1-6. doi: 10.1016/j.ajog.2007.12.035. Epub 2008 Mar 7.
PubMed 18313632Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
PubMed 10380242Cook KF, Dunn W, Griffith JW, Morrison MT, Tanquary J, Sabata D, Victorson D, Carey LM, Macdermid JC, Dudgeon BJ, Gershon RC. Pain assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S49-53. doi: 10.1212/WNL.0b013e3182872e80.
PubMed 23479545Barber MD, Kenton K, Janz NK, Hsu Y, Dyer KY, Greer WJ, White A, Meikle S, Ye W. Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):205-10. doi: 10.1097/SPV.0b013e31825e6422.
PubMed 22777368Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
PubMed 12861145Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
PubMed 16021067Nygaard IE, Clark E, Clark L, Egger MJ, Hitchcock R, Hsu Y, Norton P, Sanchez-Birkhead A, Shaw J, Sheng X, Varner M. Physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery: a protocol for a mixed-methods prospective cohort study. BMJ Open. 2017 Jan 10;7(1):e014252. doi: 10.1136/bmjopen-2016-014252.
PubMed 28073797Liebermann M, Awad M, Dejong M, Rivard C, Sinacore J, Brubaker L. Ambulation of hospitalized gynecologic surgical patients: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):533-537. doi: 10.1097/AOG.0b013e318280d50a.
PubMed 23635615Daskivich TJ, Houman J, Lopez M, Luu M, Fleshner P, Zaghiyan K, Cunneen S, Burch M, Walsh C, Paiement G, Kremen T, Soukiasian H, Spitzer A, Jackson T, Kim HL, Li A, Spiegel B. Association of Wearable Activity Monitors With Assessment of Daily Ambulation and Length of Stay Among Patients Undergoing Major Surgery. JAMA Netw Open. 2019 Feb 1;2(2):e187673. doi: 10.1001/jamanetworkopen.2018.7673.
PubMed 30707226Engel O, Haikin Herzberger E, Yagur Y, Hershko Klement A, Fishman A, Constantini N, Biron Shental T. Walking to a better future? Postoperative ambulation after cesarean delivery and complications: A prospective study. Int J Gynaecol Obstet. 2022 May;157(2):391-396. doi: 10.1002/ijgo.13815. Epub 2021 Jul 17.
PubMed 34214190Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.
PubMed 32459426Ganer Herman H, Ben Zvi M, Kleiner I, Tairy D, Kuper Sason L, Bar J, Kovo M. Mobility following cesarean delivery: an observational study utilizing pedometers. J Matern Fetal Neonatal Med. 2020 Mar;33(5):774-779. doi: 10.1080/14767058.2018.1500549. Epub 2018 Sep 10.
PubMed 30196735Nygaard IE, Shaw JM. Physical activity and the pelvic floor. Am J Obstet Gynecol. 2016 Feb;214(2):164-171. doi: 10.1016/j.ajog.2015.08.067. Epub 2015 Sep 6.
PubMed 26348380