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

Abstract

Background: Physical activity has been shown to mitigate the unwanted psychological and physiological side effects of prostate cancer treatments, but sustainable exercise possibilities are limited.

Objective: Our 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.

Methods: In 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.

Results: Attrition 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).

Conclusions: In 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 registration: ClinicalTrials.gov: NCT02430792.

Conflict of interest statement

Ethical Approval

The study was approved by the Ethics Committee for the Capital Region of Denmark (H-2-2014-099) and the Danish Data Protection Agency. All participants provided informed consent before participating.

Conflicts of Interest

All authors have completed the Unified Competing Interest form (available on request from the corresponding author) and received no support from any organization for the submitted work. Eik Dybboe Bjerre, Klaus Brasso, Anders Bojer Jørgensen, Thomas Hindborg Petersen, Alexandra Röthlin Eriksen, Anders Tolver, Jesper Frank Christensen, Mads Hvid Poulsen, Søren Sørensen Madsen, Peter Busch Østergren, Michael Borre, Christoffer Johansen, Mikael Rørth, and Julie Midtgaard have had no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years. Peter Krustrup has received funding for other research activities from the DBU, Union of European Football Associations (UEFA) and FIFA in the previous 3 years. No other relationships or activities could have influenced the submitted work.

Availability of Data and Materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Figures

Fig. 1

Flow of participants. DXA Dual-energy X-ray absorptiometry, Pca prostate cancer, () DXA lost to follow up

Fig. 2

Mean change in outcomes, according to allocation group and time points. QoL quality of life, BMD bone mineral density

Fig. 3

Weekly MET minutes, according to allocation group. MET metabolic Equivalent

Fig. 4

Mean changes in body composition based on baseline physical activity