Preventing Knee Injuries in Adolescent Female Football Players

This study has been completed.
Sponsor:
Collaborators:
Swedish Football Association
Folksam
Swedish National Centre for Research in Sports
Information provided by:
Region Skane
ClinicalTrials.gov Identifier:
NCT00894595
First received: May 6, 2009
Last updated: January 3, 2011
Last verified: December 2010
  Purpose

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 Intervention
Knee Injury
Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • The incidence of ACL injury [ Time Frame: One competitive football season ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of any acute knee injury except contusion [ Time Frame: One competitive football season ] [ Designated as safety issue: No ]

Enrollment: 4564
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894595

Locations
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
Principal Investigator: Markus Waldén, MD, PhD Linköping university
  More Information

No publications provided by Region Skane

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markus Waldén, MD, PhD, Linköping University
ClinicalTrials.gov Identifier: NCT00894595     History of Changes
Other Study ID Numbers: M197-08
Study First Received: May 6, 2009
Last Updated: January 3, 2011
Health Authority: Sweden: Regional Ethical Review Board

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:
Knee Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014