Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALPrehabilitation (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.