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

BMC Surgery

Study Protocol

Daniel Santa Mina¹  Paul Ritvo²  Armen Aprikian³  Franco Carli³  Rashami Awasthi³  Simon Tanguay³  William J Hilton⁴  Darren Au⁴  Andrew G Matthew⁵  Antonio Finelli⁵  John Trachtenberg⁵  Duminda Wijeysundera⁵  Neil E Fleshner⁵  Shabbir MH Alibhai⁶  Hance Clarke⁶ 

[1] Kinesiology Program, University of Guelph-Humber, Toronto, ON, Canada;Prostate Centre, Princess Margaret Cancer Centre, Toronto, ON, Canada;University of Guelph, Guelph, ON, Canada;Kinesiology and Health Sciences Department, York University, Toronto, ON, Canada;Cancer Care Ontario, Toronto, ON, Canada;McGill University Health Centre, Montreal, QC, Canada;Prostate Centre, Princess Margaret Cancer Centre, Toronto, ON, Canada;University of Guelph, Guelph, ON, Canada;Prostate Centre, Princess Margaret Cancer Centre, Toronto, ON, Canada;University of Toronto, Toronto, ON, Canada;University of Toronto, Toronto, ON, Canada;University Health Network, Toronto, ON, Canada;

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

DOI  :  10.1186/1471-2482-14-89

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

来源: Springer

【 摘 要 】

BackgroundAn emerging field of research describes the role of pre operative 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/DesignThis 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.DiscussionThe 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 registrationClinicaltrials.gov Identifier: NCT02036684)

【 授权许可】

CC BY   
© Santa Mina et al.; licensee BioMed Central Ltd. 2014