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

Eik Dybboe Bjerre, Thomas Hindborg Petersen, Anders Bojer Jørgensen, Christoffer Johansen, Peter Krustrup, Bente Langdahl, Mads Hvid Poulsen, Søren Sørensen Madsen, Peter Busch Østergren, Michael Borre, Mikael Rørth, Klaus Brasso, Julie Midtgaard

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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.

OriginalsprogEngelsk
Artikelnummere1002936
TidsskriftPLoS Medicine
Vol/bind16
Udgave nummer10
Antal sider15
ISSN1549-1277
DOI
StatusUdgivet - 1. okt. 2019

Fingeraftryk

Football
Prostatic Neoplasms
Randomized Controlled Trials
Bone Density
Fats
Exercise
Mental Health
Quality of Life
Random Allocation
Self Report
Hip

Citer dette

Bjerre, Eik Dybboe ; Petersen, Thomas Hindborg ; Jørgensen, Anders Bojer ; Johansen, Christoffer ; Krustrup, Peter ; Langdahl, Bente ; Poulsen, Mads Hvid ; Madsen, Søren Sørensen ; Østergren, Peter Busch ; Borre, Michael ; Rørth, Mikael ; Brasso, Klaus ; Midtgaard, Julie. / Community-based football in men with prostate cancer : 1-year follow-up on a pragmatic, multicentre randomised controlled trial. I: PLoS Medicine. 2019 ; Bind 16, Nr. 10.
@article{56751a56ca5d4c39b176c40ece801902,
title = "Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial",
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.",
author = "Bjerre, {Eik Dybboe} and Petersen, {Thomas Hindborg} and J{\o}rgensen, {Anders Bojer} and Christoffer Johansen and Peter Krustrup and Bente Langdahl and Poulsen, {Mads Hvid} and Madsen, {S{\o}ren S{\o}rensen} and {\O}stergren, {Peter Busch} and Michael Borre and Mikael R{\o}rth and Klaus Brasso and Julie Midtgaard",
year = "2019",
month = "10",
day = "1",
doi = "10.1371/journal.pmed.1002936",
language = "English",
volume = "16",
journal = "PLoS Medicine",
issn = "1549-1277",
publisher = "Public Library of Science",
number = "10",

}

Bjerre, ED, Petersen, TH, Jørgensen, AB, Johansen, C, Krustrup, P, Langdahl, B, Poulsen, MH, Madsen, SS, Østergren, PB, Borre, M, Rørth, M, Brasso, K & Midtgaard, J 2019, 'Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial', PLoS Medicine, bind 16, nr. 10, e1002936. https://doi.org/10.1371/journal.pmed.1002936

Community-based football in men with prostate cancer : 1-year follow-up on a pragmatic, multicentre randomised controlled trial. / Bjerre, Eik Dybboe; Petersen, Thomas Hindborg; Jørgensen, Anders Bojer; Johansen, Christoffer; Krustrup, Peter; Langdahl, Bente; Poulsen, Mads Hvid; Madsen, Søren Sørensen; Østergren, Peter Busch; Borre, Michael; Rørth, Mikael; Brasso, Klaus; Midtgaard, Julie.

I: PLoS Medicine, Bind 16, Nr. 10, e1002936, 01.10.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Community-based football in men with prostate cancer

T2 - 1-year follow-up on a pragmatic, multicentre randomised controlled trial

AU - Bjerre, Eik Dybboe

AU - Petersen, Thomas Hindborg

AU - Jørgensen, Anders Bojer

AU - Johansen, Christoffer

AU - Krustrup, Peter

AU - Langdahl, Bente

AU - Poulsen, Mads Hvid

AU - Madsen, Søren Sørensen

AU - Østergren, Peter Busch

AU - Borre, Michael

AU - Rørth, Mikael

AU - Brasso, Klaus

AU - Midtgaard, Julie

PY - 2019/10/1

Y1 - 2019/10/1

N2 - 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.

AB - 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.

U2 - 10.1371/journal.pmed.1002936

DO - 10.1371/journal.pmed.1002936

M3 - Journal article

C2 - 31574097

AN - SCOPUS:85072847253

VL - 16

JO - PLoS Medicine

JF - PLoS Medicine

SN - 1549-1277

IS - 10

M1 - e1002936

ER -