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Preventing Knee Injuries in Adolescent Female Football Players

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ClinicalTrials.gov Identifier: NCT00894595
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : January 4, 2011
Sponsor:
Collaborators:
Swedish Football Association
Folksam
Swedish National Centre for Research in Sports
Information provided by:
Region Skane

Study Description
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Brief Summary:

Football-related knee injuries are common and especially the anterior cruciate ligament (ACL) injury constitute a serious problem in football regardless of the playing level. The purpose of this study is to conduct a randomized controlled trial evaluating the effect of a training program designed to prevent acute knee injury in female adolescent football players.

The investigators' hypotheses are:

  1. a preventive training program reduces the incidence of ACL injury, and
  2. a high match frequency and match play at senior level increase the risk of ACL injury.

Condition or disease Intervention/treatment Phase
Knee Injury Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial
Study Start Date : August 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
The clubs in the intervention group are instructed to perform a warm-up program at two training sessions per week throughout the entire 2009 competitive season.
 Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
The preventive program (Knäkontroll, SISU Idrottsböcker©, Sweden, 2005) consists of six exercises focusing on knee control and core stability and is performed during the warm-up at two training sessions per week throughout the 2009 competitive season.
Active Comparator: Control group
The clubs in the control group are instructed to train and play as usual throughout the 2009 season
 Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
The preventive program (Knäkontroll, SISU Idrottsböcker©, Sweden, 2005) consists of six exercises focusing on knee control and core stability and is performed during the warm-up at two training sessions per week throughout the 2009 competitive season.


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of ACL injury [ Time Frame: One competitive football season ]

Secondary Outcome Measures :
  1. The incidence of any acute knee injury except contusion [ Time Frame: One competitive football season ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Teams with female football players aged 13-17 years

Exclusion Criteria:

  • Teams that did not reply to the invitation or declined participation
  • Teams having less than two scheduled training sessions per week
  • Teams already using the preventive program
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894595


Locations
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Sweden
Department of Medical and Health Sciences, Linköping University
Linköping, Sweden, 581 83
Sponsors and Collaborators
Region Skane
Swedish Football Association
Folksam
Swedish National Centre for Research in Sports
Investigators
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Principal Investigator: Markus Waldén, MD, PhD Linkoeping University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Markus Waldén, MD, PhD, Linköping University
ClinicalTrials.gov Identifier: NCT00894595    
Other Study ID Numbers: M197-08
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: December 2010
Keywords provided by Region Skane:
Incidence of ACL injury
Risk factors for ACL injury
Prevention of ACL injury or any acute knee injury
Additional relevant MeSH terms:
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Wounds and Injuries
Knee Injuries
Leg Injuries