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NCT04329715 · ClinicalTrials.gov registry record · NA
Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 123
- Enrollment target
NCT04329715 is a NA study that has completed, run by Duke University. The registered enrollment target is 123 participants.
The verdict
NCT04329715, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 123 participants
- Enrollment target
Study Summary
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
Interventions
- BEHAVIORAL Expedited postoperative activity instructions
- BEHAVIORAL Standard postoperative activity restructions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2022-02-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04329715
The ClinicalTrials.gov registry entry for NCT04329715 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Expedited postoperative activity instructions is the first listed.
NCT04329715 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04329715 about?
NCT04329715 is a clinical study titled "Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse". 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...
What is the current status of trial NCT04329715?
This trial is currently completed. It is a NA study. The enrollment target is 123 participants. The study started on 2020-07-01. Estimated completion is 2022-02-15.
What interventions are being tested in trial NCT04329715?
The interventions under investigation include: Expedited postoperative activity instructions (BEHAVIORAL), Standard postoperative activity restructions (BEHAVIORAL).
Who is sponsoring clinical trial NCT04329715?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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