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

PLoS Med. 2019 Oct 1;16(10):e1002936. doi: 10.1371/journal.pmed.1002936. eCollection 2019 Oct.

Abstract

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/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.

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.

Trial registration: ClinicalTrials.gov NCT02430792.

Publication types

  • Multicenter Study
  • Pragmatic Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Accidental Falls / prevention & control
  • Aged
  • Bone Density
  • Denmark
  • Exercise Therapy
  • Exercise*
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Patient Admission
  • Prostatic Neoplasms / epidemiology*
  • Prostatic Neoplasms / psychology
  • Prostatic Neoplasms / rehabilitation*
  • Quality of Life
  • Soccer*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02430792

Grant support

Funding/Support and role of the sponsor: TrygFonden sponsored the trial (www.trygfonden, grant IDnr: 106471, primary recipient JM). The Danish Cancer Society supplied funding for DXA scans (www.cancer.dk, primary recipient JM). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.