Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse
Public ClinicalTrials.gov record NCT04329715. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of the EVeRLAST study is to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic prolapse outcomes. We hypothesize that immediate resumption of physical activities as tolerated will result in noninferior surgical outcomes following prolapse surgery when compared to standard postoperative activity restrictions. Participants will be enrolled and randomized at their preoperative clinic visit to one of two treatment arms: Arm 1: Standard instructions (no heavy lifting over 10lbs for 6 weeks; return to work at 4 weeks for sedentary work and 6 weeks for manual labor) Arm 2: Liberal instructions (no restrictions; resume activities and work as soon as able) We will also collect subjective and objective measures of pre- and postoperative physical activity, through the use of patient-reported physical activity assessments and wrist-worn accelerometers. Accelerometer data will be collected at the preoperative, 2-week-postoperative, and 6-week-postoperative time points. Accelerometer data will also be used to calculate time to resumption of normal activities, defined as time at which a patient resumes greater than 90% of her baseline preoperative level of physical activity. We will additionally be collecting data on relevant patient-reported outcomes of pelvic floor symptom severity, health-related quality of life measures, postoperative pain, time to return to work (where relevant), and patient global impression of improvement. Postoperative anatomic assessments will be performed at 6 weeks and 3 months postoperatively by blinded study personnel
Study identification
- NCT ID
- NCT04329715
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 123 participants
Conditions and interventions
Conditions
Interventions
- Expedited postoperative activity instructions Behavioral
- Standard postoperative activity restructions Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2020
- Primary completion
- Feb 14, 2022
- Completion
- Feb 14, 2022
- Last update posted
- Mar 7, 2022
2020 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04329715, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 7, 2022 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04329715 live on ClinicalTrials.gov.