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Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial
Autoři: Eik Dybboe Bjerre aff001; Thomas Hindborg Petersen aff001; Anders Bojer Jørgensen aff001; Christoffer Johansen aff002; Peter Krustrup aff003; Bente Langdahl aff005; Mads Hvid Poulsen aff006; Søren Sørensen Madsen aff008; Peter Busch Østergren aff009; Michael Borre aff010; Mikael Rørth aff011; Klaus Brasso aff012; Julie Midtgaard aff001
Působiště autorů: University Hospitals’ Centre for Health Research, Rigshospitalet, Copenhagen, Denmark aff001; Unit of Survivorship, Danish Cancer Society Research Center, Copenhagen, Denmark aff002; Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark aff003; Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom aff004; Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark aff005; Department of Urology, Odense University Hospital, Odense, Denmark aff006; Academy of Geriatric Cancer Research, Odense University Hospital, Odense, Denmark aff007; Department of Urology, Hospital of Southwest Denmark/Esbjerg, Esbjerg, Denmark aff008; Department of Urology, Herlev and Gentofte University Hospital, Herlev, Denmark aff009; Department of Urology, Aarhus University Hospital, Aarhus, Denmark aff010; Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark aff011; Copenhagen Prostate Cancer Center, Department of Urology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark aff012; Department of Public Health, University of Copenhagen, Copenhagen, Denmark aff013
Vyšlo v časopise: Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial. PLoS Med 16(10): e32767. doi:10.1371/journal.pmed.1002936
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pmed.1002936Souhrn
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.
Klíčová slova:
Exercise – Fats – Hip – Hospitals – Mental health and psychiatry – Prostate cancer – Sports
Zdroje
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