Abstract
BackgroundPhysical exercise has been shown to be effective in relation to fatigue, aerobic fitness, and lower body strength in men with prostate cancer. However, research into the clinically relevant effects of interventions conducted in heterogeneous patient populations and in real-life clinical practice settings is warranted.Methods and findingsWe conducted a pragmatic, multicentre, parallel randomised controlled trial in 5 Danish urological departments. Recruitment began in May 2015, the first participant was randomised in June 2015, and the last participant was included in February 2017. In total, 214 men with prostate cancer were randomly assigned to either 6 months of free-of-charge football training twice weekly at a local club (football group [FG]) (n = 109) or usual care (usual care group [UG]) (n = 105), including brief information on physical activity recommendations at randomisation. Participants were on average 68.4 (SD 6.2) years old, 157 (73%) were retired, 87 (41%) were on castration-based treatment, 19 (9%) had received chemotherapy, and 41 (19%) had skeletal metastases at baseline. In this 1-year follow-up study, we evaluated the effects of community-based football training on the following outcomes: primary outcome, quality of life; secondary outcomes: continuation of football after 6 months, hip and lumbar spine bone mineral density (BMD), mental health score, fat and lean body mass, and safety outcomes, i.e., fractures, falls, and hospital admissions. Intention to treat (ITT) and per protocol (PP) analyses were conducted. No statistically significant between-group difference was observed in change in prostate-cancer-specific quality of life (ITT: 1.9 points [95% CI −1.9 to 5.8], p = 0.325; PP: 3.6 points [95% CI −0.9 to 8.2], p = 0.119). A statistically significant between-group difference was observed in change in total hip BMD, in favour of FG (0.007 g/cm2 [95% CI 0.004 to 0.013], p = 0.037). No differences were observed in change in lumbar spine BMD or lean body mass. Among patients allocated to football, 59% chose to continue playing football after the end of the 6-month intervention period. At 1-year follow-up in the PP population, FG participants had more improvement on the Mental Component Summary (2.9 [95% CI 0.0 to 5.7], p = 0.048 points higher) than UG participants, as well as a greater loss of fat mass (−0.9 kg [95% CI −1.7 to −0.1], p = 0.029). There were no differences between groups in relation to fractures or falls. Hospital admissions were more frequent in UG compared to FG (33 versus 20; the odds ratio based on PP analysis was 0.34 for FG compared to UG). There were 3 deaths in FG and 4 in UG. Main limitations of the study were the physically active control group and assessment of physical activity by means of self-report.ConclusionsIn this trial, participants allocated to football appeared to have improved hip BMD and fewer hospital admissions. Men who played football more than once a week for 1 year lost fat mass and reported improved mental health. Community-based football proved to be acceptable, even when club membership was not subsidised.Trial registrationClinicalTrials.gov NCT02430792.
Highlights
The number of men with prostate cancer is increasing; an estimated 5.6 million men are living with the disease worldwide, and in Europe, prostate cancer is the leading cause of disability due to cancer [1]
Participants allocated to football appeared to have improved hip bone mineral density (BMD) and fewer hospital admissions
We report 2 types of analysis, one on the intention to treat (ITT) population, i.e., all participants randomised at baseline, and the other on the per protocol (PP) population, i.e., including only those football group (FG) participants who adhered to the a priori PP attendance rate of a minimum of 50% of training sessions [16]
Summary
The number of men with prostate cancer is increasing; an estimated 5.6 million men are living with the disease worldwide, and in Europe, prostate cancer is the leading cause of disability due to cancer [1]. The interventions entailed whole-body resistance training with loads of 6–12 repetition maximum and aerobic exercise at 60%–85% of heart rate maximum; 2 interventions included impact loading. Overall findings from these trials showed supervised exercise to be safe and efficacious in relation to fatigue, aerobic fitness, and lower body strength [5,7,8,9,10,11]. It has been proposed that structures in the local community outside the traditional healthcare system should be used to facilitate the implementation and upscaling of exercise interventions [13] Based on this background, we initiated the “FC Prostate” research programme; qualitative findings indicated that participants regarded football as an opportunity to regain control and acquire a sense of responsibility for their own health. Research into the clinically relevant effects of interventions conducted in heterogeneous patient populations and in real-life clinical practice settings is warranted
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