NCT00894595

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,564

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 4, 2011

Status Verified

December 1, 2010

Enrollment Period

2.2 years

First QC Date

May 6, 2009

Last Update Submit

January 3, 2011

Conditions

Keywords

Incidence of ACL injuryRisk factors for ACL injuryPrevention of ACL injury or any acute knee injury

Outcome Measures

Primary Outcomes (1)

  • The incidence of ACL injury

    One competitive football season

Secondary Outcomes (1)

  • The incidence of any acute knee injury except contusion

    One competitive football season

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

The clubs in the control group are instructed to train and play as usual throughout the 2009 season

Behavioral: Knäkontroll, SISU Idrottsböcker©, Sweden, 2005

Interventions

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.

Control groupIntervention group

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Teams with female football players aged 13-17 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical and Health Sciences, Linköping University

Linköping, 581 83, Sweden

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Markus Waldén, MD, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 7, 2009

Study Start

August 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 4, 2011

Record last verified: 2010-12

Locations