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

BMC Surgery

Franco Carli⁴  Simon Tanguay⁴  Armen Aprikian⁴  Duminda Wijeysundera²  Antonio Finelli²  Neil E Fleshner²  John Trachtenberg²  Paul Ritvo¹  Hance Clarke³  Shabbir MH Alibhai³  Rashami Awasthi⁴  Darren Au⁵  William J Hilton⁵  Andrew G Matthew²  Daniel Santa Mina⁵ 

[1] Cancer Care Ontario, Toronto, ON, Canada;University of Toronto, Toronto, ON, Canada;University Health Network, Toronto, ON, Canada;McGill University Health Centre, Montreal, QC, Canada;University of Guelph, Guelph, ON, Canada

关键词: Rehabilitation;    Randomized controlled trial;    Exercise;    Prostate cancer;    Prehabilitation;   

Others  :  1091319
DOI  :  10.1186/1471-2482-14-89

 received in 2014-08-02, accepted in 2014-10-02,  发布年份 2014

【 摘 要 】

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

【 授权许可】

   
2014 Santa Mina et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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