Condition category
Injury, Occupational Diseases, Poisoning
Date applied
05/05/2008
Date assigned
12/05/2008
Last edited
11/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ostrc.no/en/Project/144---Spilleklar/

Contact information

Type

Scientific

Primary contact

Mr Torbjørn Soligard

ORCID ID

Contact details

Oslo Sports Trauma Research Center
Norwegian School of Sport Sciences
P.O. Box 4014
Ullevaal Stadion
Oslo
0806
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A comprehensive warm-up programme to prevent injuries in female youth football: a cluster randomised controlled trial

Acronym

Study hypothesis

The risk of injury is high in female football. The most common injuries occur in the lower extremities, to the foot, ankle, knee, thigh and groin. The most common injury types are strains, sprains and contusions. Female football players have a higher risk of severe injuries, such as ligament sprains in the knee, compared to male players.

The main objective of the study was to examine the effect of "The 11+", a comprehensive warm-up programme designed to reduce the risk of injuries in female youth football.

Ethics approval

Ethics approval received from The National Committees for Research Ethics on the 3rd March 2007 (ref: S-06060).

Study design

A multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Injuries to the lower extremities due to football

Intervention

This is a multi-centre cluster randomised controlled trial, where clubs were used as cluster unit and the injury recorders were blinded to the participants group allocation.

The intervention was a comprehensive warm-up programme over 20 minutes, which was to be carried out in all training sessions and matches throughout the study period (season of 2007). The programme consisted of running exercises combined with strength, balance and jumping exercises.

The players in the control group warmed up and trained as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Injuries to the lower extremity, measured (registered) prospectively throughout the data collection period (the football season of 2007 in Norway). The coaches registered injuries on registration forms sent in on a weekly basis.

Secondary outcome measures

Any injury, or an injury to the ankle, knee, or other body parts, measured (registered) prospectively throughout the data collection period (the football season of 2007 in Norway). The coaches registered injuries on registration forms sent in on a weekly basis.

Overall trial start date

15/01/2007

Overall trial end date

21/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy girls 15 and 16 years of age
2. Playing for clubs from the south, east and middle of Norway
3. Organised by the regional districts of the Norwegian Football Association
4. Clubs had to carry out at least two training sessions per week, in addition to match play

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

2500

Participant exclusion criteria

There were no exclusion criteria.

Recruitment start date

15/01/2007

Recruitment end date

21/10/2007

Locations

Countries of recruitment

Norway

Trial participating centre

Oslo Sports Trauma Research Center
Oslo
0806
Norway

Sponsor information

Organisation

Oslo Sports Trauma Research Center (Norway)

Sponsor details

Norwegian School of Sport Sciences
P.O. Box 4014
Ullevaal Stadion
Oslo
0806
Norway
+47 23 26 23 67
ostrc@nih.no

Sponsor type

Research organisation

Website

http://www.ostrc.no

Funders

Funder type

Research organisation

Funder name

Oslo Sports Trauma Research Center (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results: http://www.ncbi.nlm.nih.gov/pubmed/19066253

Publication citations

  1. Results

    Soligard T, Myklebust G, Steffen K, Holme I, Silvers H, Bizzini M, Junge A, Dvorak J, Bahr R, Andersen TE, Comprehensive warm-up programme to prevent injuries in young female footballers: cluster randomised controlled trial., BMJ, 2008, 337, a2469.

Additional files

Editorial Notes