Objective: To assess the effectiveness of the 11+ Kids warm-up programme regarding injury reduction in male high-level children`s football players. Design: Cluster-randomised controlled trial. Method: Male youth football teams of Iran`s high-level football schools were invited to participate. Inclusion criteria were: teams are competing in the highest league of their province; players are between 7 and 14 years old; regular training takes place at least twice per week. Teams were excluded if they used an injury prevention measure. Participating clubs were randomised to an intervention (INT, N = 20 teams) and a control group (CON, N = 22 teams), stratified by the number of teams and the age group. The groups were blinded against each other. The follow-up period was one season (9 months). INT replaced their warm-up by 11+ Kids. CON performed a standard warm-up programme. The primary outcome was the injury incidence density (injuries per 1000 h of football exposure), compared between groups by incidence rate ratios (RR). Results: In total, 64,047 h of football exposure of 962 players (INT = 443 players, 31,934 h of football, CON = 519 players, 32,113 h of football) were recorded. During the study, 90 (INT = 30; CON = 60) injuries occurred. The overall injury incidence density in INT was reduced by 50% compared to CON (RR 0.50; 95%-CI 0.32, 0.78). No injuries occurred during the execution of the intervention exercises. Conclusions: The 11+ Kids reduces injuries in high-level children`s football players, thus supporting player health and potentially performance and player development.
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