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Cost-effectiveness of an injury prevention program in male amateur soccer: A cluster randomised controlled trial.


- candidate number8238
- NTR NumberNTR2416
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jul-2010
- Secondary IDs50-50110-96-554 ZonMw
- Public TitleCost-effectiveness of an injury prevention program in male amateur soccer: A cluster randomised controlled trial.
- Scientific TitleCost-effectiveness of an injury prevention program in male amateur soccer: A cluster randomised controlled trial.
- ACRONYMSCORE
- hypothesisThe hypothesis is that integrating the exercises of the “The11” in the warming up is beneficial regarding injury incidence, injury severity, corresponding medical costs and/or work absenteeism.
- Healt Condition(s) or Problem(s) studiedPrevention, Efficacy, Sports, Soccer, Injuries
- Inclusion criteriaOnly male players aged 18-40 years are eligible for inclusion in the study.
- Exclusion criteriaFemale players and male players < 18 and > 40 years are excluded.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2008
- planned closingdate1-nov-2012
- Target number of participants310
- InterventionsThe injury prevention program “The11”, developed with the support of the World Soccer Association FIFA, aims at lowering the impact of the intrinsic injury risk factors in soccer. This program includes 10 exercises focusing on core stabilization, eccentric training of thigh muscles, proprioceptive training, dynamic stabilization and plyometrics with straight leg alignment. The 11th component, advice for fair play, is left out in this trial.

Twenty-three teams, playing at first class amateur level in two districts in the Netherlands participate in this study. The teams in the intervention group are instructed to perform “The11” during each practice session throughout the 2009-2010 season. All participants of the control group are asked to continue their practice sessions as usual.
- Primary outcomeThe primary outcomes of the study are individual player exposure, injury incidence and related costs (economic evaluation).
For each team information of all injuries and related costs is systematically reported in an online system by a member of the medical staff. Individual player exposure to practice sessions and games is reported weekly by the coach. Also the use of the “The11” by the soccer coaches during the season after the intervention is monitored.
- Secondary outcomeThe secondary outcomes of the study are compliance with and the quality of the execution of the prevention program during the intervention season and the subsequent season.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. F. J. G. Backx
- CONTACT for SCIENTIFIC QUERIESDrs. ing. A.M.C. Beijsterveldt, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU), department of Rehabilitation, Nursing Science & Sports, University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care, Royal Dutch Soccer Association (KNVB Zeist), Netherlands Organization for Applied Scientific Research (TNO)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Royal Dutch Soccer Association (KNVB)
- PublicationsN/A
- Brief summaryBackground:
Approximately 28% of all sports injuries in the Netherlands are the result of playing outdoor soccer. A cluster randomized controlled trial is designed to investigate the effectiveness and cost-effectiveness of an injury prevention program (“The11”) in male amateur soccer players.

Methods:
Twenty-three teams, playing at first class amateur level in two districts in the Netherlands participate in this study. The teams in the intervention group are instructed to perform “The11” during each practice session throughout the 2009-2010 season. All participants of the control group are asked to continue their practice sessions as usual. For each team information of all injuries and related costs is systematically reported in an online system by a member of the medical staff. Individual player exposure to practice sessions and games is reported weekly by the coach. Also the use of the “The11” by the soccer coaches during the season after the intervention is monitored.

Discussion:
Prevention of soccer injuries would be beneficial for players, clubs, the Royal Dutch Soccer Association (KNVB), insurance companies and society. The hypothesis is that integrating the exercises of the “The11” in the warming up is beneficial regarding injury incidence, injury severity, corresponding medical costs and/or work absenteeism.
- Main changes (audit trail)
- RECORD14-jul-2010 - 31-aug-2010


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