Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial): A Pragmatic Multicentre Randomized Controlled Trial

Abstract

BackgroundPhysical activity has been shown to mitigate the unwanted psychological and physiological side effects of prostate cancer treatments, but sustainable exercise possibilities are limited.ObjectiveOur objective was to examine whether football in a real-world setting (i.e., local football clubs) was safe and feasible in practice and could improve quality of life, mitigate decline in muscle mass and bone density, and increase fat mass in patients with prostate cancer.MethodsIn this pragmatic, multicentre, parallel randomized controlled trial, men diagnosed with prostate cancer were recruited from five Danish urological departments. Men (N = 214) diagnosed with prostate cancer were randomly allocated, using random generated lists (block size 4–8) stratified for center and androgen-deprivation therapy status, to either 1 h of football twice weekly in a local football club or to usual care, which was a 15- to 30-min telephone session covering their options for physical activity or free-of-charge rehabilitation delivered as standard in Denmark. Allocation was concealed from the trial investigator performing the randomization, but—given the nature of the intervention—this was not possible for personnel and participants. Assessments were performed at baseline, 12 weeks, and 6 months. The primary outcome was mean change difference in prostate cancer-specific quality of life at 12 weeks. Secondary outcomes were body composition, 12-Item Short Form Health Survey (SF-12) physical and mental health, and safety—reported as fractures, falls, and serious adverse events.ResultsAttrition was 1 and 3% at 12 weeks, and 5% and 5% at 6 months for the usual care and football groups, respectively. Prostate cancer-specific quality of life was equal between groups at 12 weeks (mean difference + 1.9 points, 95% confidence interval [CI] –1.0–4.8; P = 0.20) and at 6 months (+ 0.5 points, 95% CI –2.8–3.8; P = 0.76). Fractures were equally distributed, with two fractures in the usual care group and one in the football group. Likewise, body composition outcomes were equal. Mental health improved after 6 months of football (mean difference + 2.7 points, 95% CI 0.8–4.6; P = 0.006).ConclusionsIn this trial, community-based football was a feasible exercise strategy for men with prostate cancer. Football did not improve prostate cancer-specific quality of life but did improve mental health; the clinical significance of this is unclear.Trial registrationClinicalTrials.gov: NCT02430792.Electronic supplementary materialThe online version of this article (10.1007/s40279-018-1031-0) contains supplementary material, which is available to authorized users.

Effects of Small-Sided Soccer Games on Physical Fitness, Physiological Responses, and Health Indices in Untrained Individuals and Clinical Populations: A Systematic Review

“…Recently, it was concluded that community-based socceris a feasible exercise strategy for men with prostate cancer and that soccer did not improve prostate cancer-specific quality of life but did improve mental health [70]. Additionally, Uth et al [49] showed that in men undergoing androgen deprivation therapy for prostate cancer, mean HR during soccer training based on four training sessions in weeks Moreover, reducing game intensity can be achieved through reducing game space while keeping the same number of players and controlling the heart rate.…”

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

“…All participants gave written informed consent before initiating any trial activities. The trial was registered at ClinicalTrials.gov (NCT02430792), and we have previously reported the outcomes at 12 weeks and 6 months in full compliance with the registration [17].…”

“…Outcomes were assessed at 12 weeks, 6 months, and 1 year. The 12-week and 6-month outcome results have been reported elsewhere [17].…”

“…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 PP population, i.e., including only those FG participants who adhered to the a priori PP attendance rate of a minimum of 50% of training sessions [16]. The ITT population was analysed using the same statistical strategy described in our protocol for the 12-week and 6-month data [17]. The analyses on the PP population were performed with the use of principles proposed by Hernán and colleagues [22,23].…”

Female partner experiences of prostate cancer patients’ engagement with a community-based football intervention: a qualitative study

“…A multicentre randomised controlled trial (i.e., The FC Prostate Community trial) evaluating the effectiveness of community-based football programs for men with prostate cancer has shown much promise [17]. Speci cally, the football intervention (delivered in local football clubs for one hour twice weekly) was superior to the usual care (including promotion of/referral to standard rehabilitation) in mental health outcomes after six months [18], an effect sustained after 12 months in men who continued to play football [19]. Moreover, compared to men who lived alone, the study showed that men who were living with a partner adhered more regularly to the program [19].…”