A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.
BMC cancer. 2019;19(1):2
Plain language summary
Most men diagnosed with prostate cancer receive androgen deprivation therapy (ADT) and they commonly experience adverse side effects. Exercise is one of the most effective interventions to counter ADT side effects. The main aim of this study was to determine the feasibility of conducting a large multi-centre non-inferiority RCT of three exercise delivery models in men with prostate cancer on ADT. The study is a randomized phase II non-inferiority trial recruited 59 patients who were diagnosed with prostate cancer at any stage. The study compared 1:1, site-based personal training with two less-resource-intense approaches: group, site-training and individual home-based training. Results indicate that exercise adherence, as measured through attendance, was high for supervised sessions but under 50% by self-report and accelerometery. There was no difference between the three groups in terms of satisfaction. Authors conclude that both group, site-training and individual home-based training interventions in men with prostate cancer on ADT appeared to be similar to 1:1, site-based personal training for multiple efficacy outcomes.
BACKGROUND Existing evidence demonstrates that 1:1 personal training (PT) improves many adverse effects of androgen deprivation therapy (ADT). Whether less resource-intensive exercise delivery models are as effective remains to be established. We determined the feasibility of conducting a multi-center non-inferiority randomized controlled trial comparing PT with supervised group (GROUP) and home-based (HOME) exercise programs, and obtained preliminary efficacy estimates for GROUP and HOME compared to PT on quality of life (QOL) and physical fitness. METHODS Men with prostate cancer on ADT were recruited from one of two experienced Canadian centres and randomized 1:1:1 to PT, GROUP, or HOME. Randomization was stratified by length of ADT use and site. Participants completed moderate intensity aerobic and resistance exercises 4-5 days per week for 6 months with a target 150 min per week of exercise. Exercise prescriptions were individualized and progressed throughout the trial. Feasibility endpoints included recruitment, retention, adherence, and participant satisfaction. The efficacy endpoints QOL, fatigue, and fitness (VO2 peak, grip strength, and timed chair stands) in GROUP and HOME were compared for non-inferiority to PT. Descriptive analyses were used for feasibility endpoints. Between-group differences for efficacy endpoints were examined using Bayesian linear mixed effects models. RESULTS Fifty-nine participants (mean age 69.9 years) were enrolled. The recruitment rate was 25.4% and recruitment was slower than projected. Retention was 71.2%. Exercise adherence as measured through attendance was high for supervised sessions but under 50% by self-report and accelerometry. Satisfaction was high and there was no difference in this measure between all three groups. Between-group differences (comparing both GROUP and HOME to PT) were smaller than the minimum clinically important difference on most measures of QOL, fatigue, and fitness. However, two of six outcomes for GROUP and four of six outcomes for HOME had a > 20% probability of being inferior for GROUP. CONCLUSIONS Feasibility endpoints were generally met. Both GROUP and HOME interventions in men with PC on ADT appeared to be similar to PT for multiple efficacy outcomes, although conclusions are limited by a small sample size and cost considerations have not been incorporated. Efforts need to be targeted to improving recruitment and adherence. A larger trial is warranted. TRIAL REGISTRATION ClinicalTrials.gov: NCT02046837 . Date of registration: January 20, 2014.