Back to resultsPreventing Knee Injuries in Adolescent Female Football Players
Primary Purpose
Knee Injury
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
Sponsored by
About this trial
This is an interventional prevention trial for Knee Injury focused on measuring Incidence of ACL injury, Risk factors for ACL injury, Prevention of ACL injury or any acute knee injury
Eligibility 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
Sites / Locations
- Department of Medical and Health Sciences, Linköping University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
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.
The clubs in the control group are instructed to train and play as usual throughout the 2009 season
Outcomes
Primary Outcome Measures
The incidence of ACL injury
Secondary Outcome Measures
The incidence of any acute knee injury except contusion
Full Information
NCT ID
NCT00894595
First Posted
May 6, 2009
Last Updated
January 3, 2011
Sponsor
Region Skane
Collaborators
Swedish Football Association, Folksam, Swedish National Centre for Research in Sports
1. Study Identification
Unique Protocol Identification Number
NCT00894595
Brief Title
Preventing Knee Injuries in Adolescent Female Football Players
Official Title
Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Region Skane
Collaborators
Swedish Football Association, Folksam, Swedish National Centre for Research in Sports
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
a preventive training program reduces the incidence of ACL injury, and
a high match frequency and match play at senior level increase the risk of ACL injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injury
Keywords
Incidence of ACL injury, Risk factors for ACL injury, Prevention of ACL injury or any acute knee injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4564 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The clubs in the control group are instructed to train and play as usual throughout the 2009 season
Intervention Type
Behavioral
Intervention Name(s)
Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of ACL injury
Time Frame
One competitive football season
Secondary Outcome Measure Information:
Title
The incidence of any acute knee injury except contusion
Time Frame
One competitive football season
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Waldén, MD, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical and Health Sciences, Linköping University
City
Linköping
ZIP/Postal Code
581 83
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22556050
Citation
Walden M, Atroshi I, Magnusson H, Wagner P, Hagglund M. Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial. BMJ. 2012 May 3;344:e3042. doi: 10.1136/bmj.e3042.
Results Reference
derived
PubMed Identifier
19545453
Citation
Hagglund M, Walden M, Atroshi I. Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595]. BMC Musculoskelet Disord. 2009 Jun 23;10:75. doi: 10.1186/1471-2474-10-75.
Results Reference
derived
Learn more about this trial
Preventing Knee Injuries in Adolescent Female Football Players
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