Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial)

A Pragmatic Multicentre Randomized Controlled Trial

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, Peter Krustrup, Christoffer Johansen, Mikael Rørth, Julie Midtgaard

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Resumé

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.

OriginalsprogEngelsk
TidsskriftSports Medicine
Vol/bind49
Udgave nummer1
Sider (fra-til)145-158
ISSN0112-1642
DOI
StatusUdgivet - 25. jan. 2019

Fingeraftryk

Football
Prostatic Neoplasms
Randomized Controlled Trials
Quality of Life
Exercise
Mental Health
Confidence Intervals
Denmark
Random Allocation
Health Surveys
Bone Density
Fats
Research Personnel
Muscles

Citer dette

Bjerre, E. D., Brasso, K., Jørgensen, A. B., Petersen, T. H., Eriksen, A. R., Tolver, A., ... Midtgaard, J. (2019). Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial): A Pragmatic Multicentre Randomized Controlled Trial. Sports Medicine, 49(1), 145-158. https://doi.org/10.1007/s40279-018-1031-0
Bjerre, Eik Dybboe ; Brasso, Klaus ; Jørgensen, Anders Bojer ; Petersen, Thomas Hindborg ; Eriksen, Alexandra Röthlin ; Tolver, Anders ; Christensen, Jesper Frank ; Poulsen, Mads Hvid ; Madsen, Søren Sørensen ; Østergren, Peter Busch ; Borre, Michael ; Krustrup, Peter ; Johansen, Christoffer ; Rørth, Mikael ; Midtgaard, Julie. / Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial) : A Pragmatic Multicentre Randomized Controlled Trial. I: Sports Medicine. 2019 ; Bind 49, Nr. 1. s. 145-158.
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title = "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.",
author = "Bjerre, {Eik Dybboe} and Klaus Brasso and J{\o}rgensen, {Anders Bojer} and Petersen, {Thomas Hindborg} and Eriksen, {Alexandra R{\"o}thlin} and Anders Tolver and Christensen, {Jesper Frank} and Poulsen, {Mads Hvid} and Madsen, {S{\o}ren S{\o}rensen} and {\O}stergren, {Peter Busch} and Michael Borre and Peter Krustrup and Christoffer Johansen and Mikael R{\o}rth and Julie Midtgaard",
year = "2019",
month = "1",
day = "25",
doi = "10.1007/s40279-018-1031-0",
language = "English",
volume = "49",
pages = "145--158",
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Bjerre, ED, Brasso, K, Jørgensen, AB, Petersen, TH, Eriksen, AR, Tolver, A, Christensen, JF, Poulsen, MH, Madsen, SS, Østergren, PB, Borre, M, Krustrup, P, Johansen, C, Rørth, M & Midtgaard, J 2019, 'Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial): A Pragmatic Multicentre Randomized Controlled Trial', Sports Medicine, bind 49, nr. 1, s. 145-158. https://doi.org/10.1007/s40279-018-1031-0

Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial) : A Pragmatic Multicentre Randomized Controlled Trial. / Bjerre, Eik Dybboe; Brasso, Klaus; Jørgensen, Anders Bojer; Petersen, Thomas Hindborg; Eriksen, Alexandra Röthlin; Tolver, Anders; Christensen, Jesper Frank; Poulsen, Mads Hvid; Madsen, Søren Sørensen; Østergren, Peter Busch; Borre, Michael; Krustrup, Peter; Johansen, Christoffer; Rørth, Mikael; Midtgaard, Julie.

I: Sports Medicine, Bind 49, Nr. 1, 25.01.2019, s. 145-158.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial)

T2 - A Pragmatic Multicentre Randomized Controlled Trial

AU - Bjerre, Eik Dybboe

AU - Brasso, Klaus

AU - Jørgensen, Anders Bojer

AU - Petersen, Thomas Hindborg

AU - Eriksen, Alexandra Röthlin

AU - Tolver, Anders

AU - Christensen, Jesper Frank

AU - Poulsen, Mads Hvid

AU - Madsen, Søren Sørensen

AU - Østergren, Peter Busch

AU - Borre, Michael

AU - Krustrup, Peter

AU - Johansen, Christoffer

AU - Rørth, Mikael

AU - Midtgaard, Julie

PY - 2019/1/25

Y1 - 2019/1/25

N2 - 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.

AB - 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.

U2 - 10.1007/s40279-018-1031-0

DO - 10.1007/s40279-018-1031-0

M3 - Journal article

VL - 49

SP - 145

EP - 158

JO - Sports Medicine

JF - Sports Medicine

SN - 0112-1642

IS - 1

ER -