Prehabilitation for men undergoing radical prostatectomy: a multi-centre, pilot randomized controlled trial

Daniel Santa Mina, Andrew G Matthew, William J Hilton, Darren Au, Rashami Awasthi, Shabbir M H Alibhai, Hance Clarke, Paul Ritvo, John Trachtenberg, Neil E Fleshner, Antonio Finelli, Duminda Wijeysundera, Armen Aprikian, Simon Tanguay, Franco Carli, Daniel Santa Mina, Andrew G Matthew, William J Hilton, Darren Au, Rashami Awasthi, Shabbir M H Alibhai, Hance Clarke, Paul Ritvo, John Trachtenberg, Neil E Fleshner, Antonio Finelli, Duminda Wijeysundera, Armen Aprikian, Simon Tanguay, Franco Carli

Abstract

Background: An emerging field of research describes the role of preoperative health behaviours, known as prehabilitation. The preoperative period may be a more physically and emotionally salient time to introduce and foster chronic adherence to health behaviours, such as exercise, in patients compared to post-treatment during recovery. Moreover, physical and psychosocial improvements during the preoperative period may translate into an enhanced recovery trajectory with reduced operative complications and postoperative adverse effects. No studies have assessed prehabilitation for men with prostate cancer undergoing radical prostatectomy.

Methods/design: This is a multi-centre, pilot randomized control trial conducted at two Canadian urban teaching hospitals. 100 men undergoing radical prostatectomy for prostate cancer with no contraindications to exercise will be recruited and randomized to the prehabiliation program or usual care. Prehabilitation participants will engage in a preoperative, individualized exercise program including pelvic floor muscle strengthening instructions and a healthy lifestyle guide for men with prostate cancer. These participants will be asked to engage in 60 minutes of home-based, unsupervised, moderate-intensity exercise on 3-4 days per week. Usual care participants will receive the same pelvic floor muscle strengthening instructions and healthy lifestyle guide only. We will assess the feasibility of conducting an adequately powered trial of the same design via recruitment rate, programmatic adherence/contamination, attrition, and safety. Estimates of intervention efficacy will be captured through measurements at baseline (4-8 weeks preoperatively), within 1 week prior to surgery, and postoperatively at 4, 12, and 26 weeks. Efficacy outcomes include: fatigue, quality of life, urinary incontinence, physical fitness, body composition, aerobic fitness, pain, and physical activity volume.

Discussion: The primary outcome of this study is to determine the feasibility of conducting a full-scale, randomized controlled trial of prehabilitation versus usual care and to estimate effect sizes that will inform sample size determinations for subsequent trials in this field. To our knowledge, this is the first study to examine a structured presurgical exercise program for men undergoing radical prostatectomy for prostate cancer. This trial will advance our understanding of strategies to efficiently and effectively use the preoperative period to optimize postoperative recovery.

Trial registration: Clinicaltrials.gov Identifier: NCT02036684.

Figures

Figure 1
Figure 1
Participant flow.

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