Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.