A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy

Abstract

BackgroundExisting 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.MethodsMen 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.ResultsFifty-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.ConclusionsFeasibility 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 registrationClinicalTrials.gov: NCT02046837. Date of registration: January 20, 2014.Electronic supplementary materialThe online version of this article (10.1186/s12885-018-5189-5) contains supplementary material, which is available to authorized users.

Effects of six months of aerobic and resistance training on metabolic markers and bone mineral density in older men on androgen deprivation therapy for prostate cancer

“…Fifty-three participants were enrolled in the main trial [17]. Three participants had metastatic PCa at baseline.…”

“…Resistance training included the following exercises: seated row, push-ups, stability ball squat, hamstring curl, bicep curl, triceps extension, upright row, and plank. Intervention adherence measures included self-reported and objectively measured MVPA via the Godin Leisure-Time Exercise Questionnaire and Actigraph GTX3, (Pensacola, FL) [17] Compliance to the intervention (i.e. attended supervised exercise sessions/prescribed supervised exercise sessions) was assessed only for PT and GROUP.…”

Physical activity and nutrition interventions for older adults with cancer: a systematic review

“…This review included 14 papers [47][48][49][50][51][52][53][54][55][56][57][58][59][60]. A further eight related papers were referenced to provide more detail when unable to find information in the primary paper (e.g.…”

“…protocol papers) [61][62][63][64][65][66][67][68]. One study was a three-arm randomized controlled trial (RCT) [47] with the remaining 13 studies being twoarm RCTs. One study was described as a pilot [51] and seven as feasibility [47,48,50,54,55,58,60] RCTs.…”

“…One study was described as a pilot [51] and seven as feasibility [47,48,50,54,55,58,60] RCTs. Seven studies took place in the USA [49,50,55,56,59,60], two in Canada [47,51] and one each in China [52], Japan [54], Korea [57], Sweden [58] and UK [48]. Five studies recruited patients with prostate cancer only [47,48,55,57,60], one each recruited bladder [58], lung [52] and breast cancer only [51], with the remaining recruiting a mixed sample of cancer types [49,50,53,54,56,59].…”