Trials / Completed
CompletedNCT02036684
Prehabilitation for Prostate Cancer Surgery
A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- University of Guelph-Humber · Academic / Other
- Sex
- Male
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life which may persist for up to two years postoperatively. The primary objective of this trial is to assess the feasibility of conducting of a multi-site randomized controlled trial to test the effect of a comprehensive prehabilitation program versus standard care for men with prostate cancer undergoing radical prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle exercises) will report better health-related quality of life, urological symptoms, and physical fitness, physical activity, and pain, as well as a shorter postoperative length of stay than participants receiving standard preoperative care (pelvic floor muscle exercises alone). Our secondary objective is to report estimates of efficacy on several clinically important outcomes for this population that will be used for sample size calculations in an adequately powered trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Prehabilitation (PREHAB) |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2016-05-17
- Completion
- 2016-05-17
- First posted
- 2014-01-15
- Last updated
- 2017-08-23
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT02036684. Inclusion in this directory is not an endorsement.