support of the World Football Association FIFA, also focuses on injury prevention.16 The effects of The11 on injury rates have been investigated previously. One study found that the programme significantly reduced injury rates (21% fewer injuries) in male Swiss junior soccer players.17 However, this injury prevention effect was not observed in female Norwegian junior soccer players.18 The preventive effect of The11 has not been studied in male adult soccer players, who represent the largest group of active participants in soccer worldwide with high injury incidence rates.2,19 tion focuses specifically on male adult soccer players. As proposed by van Mechelen et al,20 our study addressed steps three and four of the prevention sequence model: introducing preventive activities to reduce future risk and/ or severity of sports injuries, and assessing their effectiveness. The aim of the present study was therefore to investigate the effectiveness of The11 in this high-risk population of adult male amateur soccer players. We hypothesized that these exercises, when integrated in the warm-up of each practice session, would have a preventive effect on injury incidence and/or injury severity compared to usual practice sessions without The11. Methods Trial design and randomisation In accordance with the principles of intention to treat, the effectiveness of the The11 injury prevention programme was evaluated in a two-armed cluster-randomised controlled trial. To minimise contamination, randomisation took place at cluster level, namely that of regional competitions. The trial was approved by the medical ethics committee of the University Medical Centre Utrecht and was registered in the Dutch trial register (NTR2416). For more detailed information regarding the methods, the reader is referred to the study protocol published elsewhere.21 Participants Teams from two geographically separated districts in Dutch high-level amateur soccer were invited to participate in the study. Male players from these teams, who were aged between 18 and 40 years, were eligible for inclusion. They generally had two or three practice sessions and one match each week. Players who left the team during the season were included in the study, taking the time they spent on the team into account. All players provided a written informed consent at the start of the trial. Therefore, our research on injury prevenIntervention The11 injury prevention programme has been developed with the support of the World Football Association FIFA. It includes 10 exercises focusing on core stability, eccentric training of thigh muscles, proprioceptive training, dynamic stabilisation and plyometrics with straight leg alignment.16 The 11th component, fair play advice, was not included in the present trial. The11 included the following exercises: the bench, sideways bench, hamstrings, cross-country skiing, chest passing in single-leg stance, forward bend in single-leg stance, figures-ofeight in single-leg stance, jumps over a line, zigzag shuffle and bounding. During the 2009–2010 soccer season (September–May), coaches of the teams in the intervention group were instructed to integrate The11 in the warm-up of each practice session (at least twice a week). Coaches were trained in applying The11 by the research staff at the end of the 2008–2009 season. In addition, coaches received a detailed information package (DVD, poster and reader) presenting the basic elements of the injury prevention programme. Coaches and players in the intervention group familiarised themselves with the programme during the 5 weeks preceding the start of the season ( July–August), after which the programme was fully implemented in practice sessions at the start of the season. For players who are familiar with the exercises, the programme takes about 10–15 min. Coaches in the control group were invited to participate in a study of injury incidence and the characteristics of practice sessions. All participants in the control group continued their practice sessions as usual. During the season, practice sessions of each team were visited by observers and members of the research staff each month. The purpose of these visits was to monitor the actual use of implementation of the The11 injury prevention programme in the intervention group. Random visits to the control group were scheduled to observe and record possible self-initiated preventive measures in their warm-up, specifically those of The11. Data collection procedure During the preseason, all players were asked to fill up a questionnaire to record baseline characteristics. During the 2009–2010 season, individual information about each participant’s exposure to soccer (numbers of practice sessions and matches) was reported weekly by the coaches, using a computer-based recording form. When a player was not present at a regular practice session or game, the reason for his absence was reported on the exposure form as ‘injured’ or ‘other’. nummer 5 | december 2012 | Sport & Geneeskunde 7 Pagina 6

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