BMJ open · 2025
Enhancing Prevention of Injuries in Community youth and adult amateur football teams (EPIC) via implementation support for an exercise-based intervention: study protocol for a type 3 hybrid implementation-effectiveness cluster-randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Lindblom Hanna, Sonesson Sofi, Waldén Markus, Åkerlund Ida, Ivarsson Andreas, Hägglund Martin
Аннотация
INTRODUCTION: Injury prevention exercise programmes with multiple components are efficacious in reducing injuries in youth and adult football. However, obtaining high adherence to the programmes over time is an unsolved challenge. Previous studies report that players lack motivation for injury prevention training and that coaches need ongoing support when using these programmes. The overall purpose of this study is to compare the added value of implementation support on the implementation and preventive efficacy of the Knee Control+programme in male and female, youth and adult amateur football teams.
METHODS AND ANALYSIS: This is a type 3 hybrid cluster-randomised controlled trial with adherence to the Knee Control+ injury prevention programme as the primary outcome and preventive efficacy as secondary outcomes. The study will take place during the 2025 football season (April/May to October/November) in Sweden, and we aim to enrol a minimum of 117 teams with players 10 years of age and older. All teams will have access to Knee Control+ via the Swedish Football Association (FA) website and are instructed to use the programme throughout the season. Teams randomised to the intervention group will receive support for implementation of Knee Control+, and the control group will receive no implementation support. This support primarily targets coaches and consists of a smorgasbord of activities and material including physical and digital workshops, leaflets, digital material and site visits to the teams. Codesign with coaches and players was employed during the design of the implementation support. Players report use of Knee Control+ and any injuries or complaints monthly, and coaches report training and use of Knee Control+ weekly, via web-based questionnaires. Adherence to Knee Control+ (primary) and preventive effects on injury incidence and prevalence (secondary) will be compared between groups.
ETHICS AND DISSEMINATION: The study was approved by the Swedish Ethical Review Authority (Dnr 2024-07394-01). Implementation support interventions that are appreciated by the players and/or coaches will be made available and free to use on the Swedish FA website after the study's conclusion. Fitness trainers will be able to hold workshops and make site visits after the study has been completed.
TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT06748443).
METHODS AND ANALYSIS: This is a type 3 hybrid cluster-randomised controlled trial with adherence to the Knee Control+ injury prevention programme as the primary outcome and preventive efficacy as secondary outcomes. The study will take place during the 2025 football season (April/May to October/November) in Sweden, and we aim to enrol a minimum of 117 teams with players 10 years of age and older. All teams will have access to Knee Control+ via the Swedish Football Association (FA) website and are instructed to use the programme throughout the season. Teams randomised to the intervention group will receive support for implementation of Knee Control+, and the control group will receive no implementation support. This support primarily targets coaches and consists of a smorgasbord of activities and material including physical and digital workshops, leaflets, digital material and site visits to the teams. Codesign with coaches and players was employed during the design of the implementation support. Players report use of Knee Control+ and any injuries or complaints monthly, and coaches report training and use of Knee Control+ weekly, via web-based questionnaires. Adherence to Knee Control+ (primary) and preventive effects on injury incidence and prevalence (secondary) will be compared between groups.
ETHICS AND DISSEMINATION: The study was approved by the Swedish Ethical Review Authority (Dnr 2024-07394-01). Implementation support interventions that are appreciated by the players and/or coaches will be made available and free to use on the Swedish FA website after the study's conclusion. Fitness trainers will be able to hold workshops and make site visits after the study has been completed.
TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT06748443).