Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial.

Background Physical 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 findings We 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/cm(2) [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. Conclusions In 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. Author summaryWhy was this study done? Sports is often referred to as an applicable and useful public health strategy for promoting physical activity in clinical populations, but to our knowledge no randomised controlled trials have examined this possibility in sports clubs. Prostate cancer is the most common cancer in men. Men with prostate cancer can suffer severe morbidity from medical treatments that possibly can be mitigated by exercising and being physical active. What did the researchers do and find? We carried out a pragmatic randomised controlled trial involving 214 men with prostate cancer. Participants were either offered football training in a local club or recommended to continue their active normal life, and were studied over 1 year. We found that more than half of participants allocated to football training continued with football in the club even when they had to pay their club membership fee themselves. In this setting, men with prostate cancer appeared to have improved hip bone density and were also admitted to hospital less frequently when allocated to a local football club. Playing football did not change men's scores of prostate-cancer-specific quality of life. The men who played football more than 1 time a week had improved mental health scores and lost fat mass. What do these findings mean? Clinicians can encourage men with prostate cancer to engage in local sports activities to mitigate some of the negative effects of medical treatments. Sports can be a strategy for some men with prostate cancer in substitution for other exercise. Our findings are limited by the setting the study was implemented in: Denmark is a country with a highly active population and many local football clubs.