Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial
Introduction
Radical prostatectomy (RP) is a common and effective treatment for localized prostate cancer (PCa). While significant morbidity and mortality resulting from RP is relatively low, many PCa survivors experience ongoing adverse effects, including: reduced physical function, fatigue, urinary incontinence and erectile dysfunction, that collectively diminish health-related quality of life (HRQOL) for 6–12 months, or in some cases, indefinitely [[1], [2], [3], [4]]. Advances in PCa management have increased the survivorship population driving strategies to improve HRQOL after treatment.
Interventions to enhance RP-recovery and mitigate adverse effects are often introduced postoperatively. Such approaches have targeted erectile dysfunction and urinary incontinence through provision of pharmacologic and/or pelvic floor exercises [5,6]. However, RP patients are not often prescribed interventions to address the noticeable and persistent limitations to functional capacity and general deconditioning. Numerous studies report RP-related deconditioning that limits capacity for physical and/or occupational activity for up to approximately six months [7,8]. Capacity for work is a relevant health outcome where diminished ability to perform physical duties is a predictor of premature retirement and risk of death [9,10]. A focused effort to address the functional limitations affecting RP patients is crucial.
Patients who are active and well-functioning prior to surgery recuperate faster, have fewer complications, and experience better recovery compared to their less fit counterparts [11]. For men undergoing RP, studies have shown that preoperative physical fitness and physical activity are associated with improved postoperative HRQOL and urinary incontinence [12,13]. Given the relationship between preoperative physical activity, physical fitness and postoperative outcomes, a growing body of literature suggests intervening prior to surgery to optimize treatment success – a process known as prehabilitation [14,15]. Reviews of prehabilitation describe benefit to postoperative physical and psychosocial well-being as well postoperative length of stay and surgical complications [16,17]. For men undergoing RP recent studies have demonstrated preliminary feasibility [18,19]; however, small samples, absence of clinical outcomes, and lack of exercises targeted at regional morbidity (i.e. urinary incontinence) limit their interpretation. The objectives of this RCT were to assess the feasibility and effect of a personalised, home-based prehabilitation intervention on clinically-relevant outcomes in RP patients.
Section snippets
Methods
This phase 2 RCT compared a prehabilitation (PREHAB) intervention versus a control condition (CON) in men undergoing RP at two urban academic medical centres in Canada. Ethics approval was obtained and all participants provided written informed consent. This paper reports the results of one preregistered study, which can be accessed at clinicaltrial.gov (https://clinicaltrials.gov/ct2/show/NCT02036684). A detailed trial protocol of study methodology is published elsewhere [20] and briefly
Participation and trial feasibility
The CONSORT (Consolidated Standards of Reporting Trials) diagram is presented in Fig. 1 and trial feasibility data are summarized in Table 1. From February 2014 to September 2015, 185 patients were approached for participation. Fifty and 36 participants were recruited in Toronto and Montreal, respectively (n = 86/185; 46.5%) and randomly assigned to PREHAB (n = 44) and CON (n = 42). Primary reasons for declining to participate were lack of transportation/too far to travel (n = 30) and not
Discussion
Our primary objective was to assess feasibility of a multi-centre RCT examining home-based prehabilitation versus a control condition in men undergoing radical prostatectomy. Trial participation was 47% of eligible patients approached – a recruitment rate that is favourable compared to exercise trials in the hormone and/or radiation therapy setting [[23], [24], [25]]. In recent studies of prehabilitation in the RP setting, Singh et al. [17] reported that 14 of 16 participants screened for
Conclusion
An RCT comparing home-based, total-body prehabilitation plus pelvic floor training to pelvic floor training alone is feasible. Our analyses suggests that prehabilitation hastens return to baseline for functional capacity and reduces preoperative and 6-month postoperative anxiety. These findings are consistent with previous literature describing the benefits of prehabilitation. Larger trials are needed to more precisely understand its effects in men undergoing RP and for those whom are most
Conflicts of interest
The authors declare that they have no conflicts of interest.
Funding source
Prostate Cancer Canada (#D2013-27) and the University of Guelph-Humber Research Grant Program.
Registration number
Acknowledgments
This study received in-kind support from the Cancer Rehabilitation and Survivorship Program at the Princess Margaret Cancer Centre and the Peri Operative Program of McGill University. Furthermore, we would like to extend our sincere appreciation to the actors in our exercise videos: Winnie Talan, Stanley Gordon, David Buhler, Ken Sullivan, and Lance Carlson.
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