We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preventing Knee Injuries in Adolescent Female Football Players

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 6, 2009
First Posted Date  ICMJE May 7, 2009
Last Update Posted Date January 4, 2011
Study Start Date  ICMJE August 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2009)		 The incidence of ACL injury [ Time Frame: One competitive football season ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2009)		 The incidence of any acute knee injury except contusion [ Time Frame: One competitive football season ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Knee Injuries in Adolescent Female Football Players
Official Title  ICMJE Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Knee Injury
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
  • Active Comparator: Control group
    The clubs in the control group are instructed to train and play as usual throughout the 2009 season
    Intervention: Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2011)		 4564
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2009)		 6000
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00894595
Other Study ID Numbers  ICMJE M197-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Markus Waldén, MD, PhD, Linköping University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Region Skane
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Swedish Football Association
  • Folksam
  • Swedish National Centre for Research in Sports
Investigators  ICMJE
Principal Investigator: Markus Waldén, MD, PhD Linkoeping University
PRS Account Region Skane
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP