Clinical Trial

Enhancing Prevention of Injuries in Community Youth and Adult Amateur Football Players

Study acronym: EPIC
Recruiting
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Record status
This record was last updated April 27, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a type 3 hybrid cluster randomised controlled trial, where implementation of the intervention is the primary outcome and preventive effectiveness is the secondary outcome. The overall purpose of this study is to evaluate the added value of implementation support on the use and preventive effectiveness of the injury prevention exercise programme Knee Control+ in male and female, youth and adult amateur football teams. Research questions 1. Does use and injury preventive effect of Knee Control+ differ between teams randomised to an intervention group receiving additional support for Knee Control+ use and teams randomised to a control group with standard access to digital Knee Control+ programme material? 2. Does coach self-efficacy to use Knee Control+, player motivation and player training dosage differ between the intervention and control groups? 3. What are the mediators and moderators that influence use of Knee Control+? 4. How well do the intervention and control groups adhere to Knee Control+ recommended use and is there an association between adherence and preventive efficacy? 5. How are different components of the support material used by the intervention group teams, and how is the implementation support perceived by administrators, coaches and players in the clubs (end-users) and by fitness coaches who educate coaches about the programme (intervention deliverers)? 6. How do coaches perceive their engagement to lead Knee Control+ training with their players and has this changed after having used the implementation support material? Football teams will be randomised before the 2025 season to an intervention group receiving additional support for the implementation of Knee Control+ or to a control group without this support. All teams will have access to digital programme material via the Swedish Football Association. Data on implementation of Knee Control+ and injuries (players only) will be collected weekly (coaches) and monthly (players) throughout the season using web-based questionnaires. Behavioural outcomes: for coaches self-efficacy, action and coping planning and perceived support from the club, and for players autonomous motivation, basic psychological needs and basic need support, will also be analysed.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-12-20; most recent amendment 2025-04-24.
Status change: Not Yet Recruiting → Recruiting 2025-04-24
Trial Details
NCT Number NCT06748443
Lead Sponsor Linkoeping University
Collaborators: The Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare
Conditions Injury Prevention in Sports, Adherence
Enrollment 1,600 participants
Start Date 2025-03-25
Primary Completion 2025-11 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-04-27