Condition category
Mental and Behavioural Disorders
Date applied
20/09/2012
Date assigned
25/09/2012
Last edited
30/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Previous studies have shown that for youth sports, muscular warm-up routines can reduce injury risk. A study in Norway showed The FIFA 11+ program in reduced the risk of all injuries by 32%, and leg injuries by 29%. In the same project, it was also shown that there is a greater protective effect in players who keep up with the FIFA 11+ program, meaning a risk reduction of all injuries by 35% for those players participating.
A similar injury prevention warm-up program yielded a protective effect of a 38% reduction in injuries in Canada. To maximize the benefit of effective injury prevention programs, we investigated the behavioural change required to increase the number players starting to use the program, and continue to use the program in the long term.

Who can participate?
Female soccer players, aged 14 to 18 years from 29 minor soccer teams from the Premiere Division, in Canada and playing in the 2011 outdoor season.

What does the study involve?
A total of 385 female soccer players (14 to 18 yrs) from 29 teams were randomly allocated to one of 3 groups. The first group participated in the FIFA 11+program, and were followed up weekly. The second group participated in the FIFA 11+program and access to a personal contact every 2 weeks. Control group were only given the link to the FIFA 11+ website. Each player was assessed to see how well they used the FIFA 11+ program, if they experienced injuries and were followed-up weekly.
Adherence (how well the players continued with the program) was based on the number of sessions completed with the FIFA 11+ out of the total amount of sessions possible, as well as the time spent on the warm-ups completed by the team. Before the start of the study period and after the final game of the study period, all head, assistant and conditioning coaches and players in were asked to complete a survey to evaluate coach and player attitudes and knowledge to injury prevention. In addition, all players were asked to participate in assessments examining functional balance and jumping abilities.

What are the possible benefits and risks of participating?
Participants who experience a soccer injury during the study may be offered a free onfield assessment by a physiotherapist. Further more, participants with serious injuries where time loss from soccer is greater than 7 days may be referred to a sport medicine physician for an assessment at no charge. There are no expected risks of participating in the study as the program has previously shown a protective effect against injury. However there is a risk of injury or muscular soreness due to poor technique, or rapid increase in exercise level.

Where is the study run from?
Calgary , Edmonton, and Red Deer Alberta, Canada

When is study starting and how long is it expected to run for?
The study took place between April and September 2011

Who is funding the project?
Federation Internationale de Football Association (FIFA)

Who is the main contact?
Dr Carolyn Emery
caemery@ucalgary.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Winne Meeuwisse

ORCID ID

Contact details

University of Calgary
Sport Medicine Centre
376 Collegiate Blvd
Calgary
T2N 1N4
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of different delivery methods of the FIFA 11+ soccer warm-up program on coach and player adherence in Canadian female youth soccer players

Acronym

Study hypothesis

Does the comprehensive delivery of the FIFA 11+ injury prevention warm-up program have a more significant effect in maximizing team and player adherence and improving neuromuscular performance among youth soccer players, than a self-regulated delivery among teams with unsupervised access to FIFA 11+ program resources?

Ethics approval

Conjoint Health Research Ethics Board, The University of Calgary, 07 April 2011 ref: 23791

Study design

This is a single-centre RCT with co-investigators from other international centres. Teams were
block-randomized into one of three groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please contact Maria Romiti, maromiti@ucalgary.ca to request a patient information sheet

Condition

Adherence to the FIFA 11+ neuromuscular warm-up program and it's affect on lower limb and overall injury risk, performance and injury prevention beliefs

Intervention

Control group teams: were given online access to the FIFA 11+ website

Regular intervention group teams: in addition to online access of the FIFA11+ website (as per Control group) this group was provided with hardcopies of educational material given through the FIFA 11+ website (DVD, cards, and posters). Coaches from these teams also were required to attend a 1-2 hour pre-season coaching workshop where the FIFA 11+ program was delivered to them by research personnel.

Intervention group teams: As well as being given online access to the FIFA11+ website (as per Control group), program resources and attendance to a coaching workshop (as per Regular intervention group), teams in this group were assigned study personnel (physiotherapist, athletic therapist or trainer) to teach the intervention program to the coaches and players, and participate weekly in a team session to correct technique and progress through the program components.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Team adherence to the FIFA 11+, based on the total number and the proportion of the total number of possible sessions completed, warm-up components completed and the total time for warm-up sessions completed (i.e. target 20 minutes per session warm-up).

Secondary outcome measures

1. Coaches’ and players´ attitudes to and knowledge of injury prevention, which will be assessed pre and post-season. Measured qualitatively and quantitatively through Theory of Planned Behaviour Model
2. Changes in neuromuscular performance measures carried out as field-tests on all intervention and control players pre-and post-season. These include unipedal balance test (s), Star Excursion Balance Test (cm), triple single leg hop (cm), jumping over a bar (#)
3. Injury rates (per 1000 hr of exposure) as well as injury rate ratios

Overall trial start date

01/04/2011

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Female youth soccer players (ages 14 to 18 years) participating in a minor soccer team within Alberta at the commencement of the 2011 outdoor soccer season (Premiere Division
Tiers 1-3, U16, U18).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

360 players

Participant exclusion criteria

1. Recent (within 6 weeks) history of back or lower extremity injury requiring medical attention or the inability to participate in soccer for at least one day and preventing the player from participating fully at the commencement of the 2011 outdoor season
2. History of systemic disease (e.g. cancer, arthritis, heart disease), neurological disorder (i.e. head injury, cerebral palsy), preventing the ability to participate fully at the commencement of the 2011 outdoor soccer season
3. History of bone fracture or surgery in the past year, preventing the ability to participate fully at the commencement of the 2011 outdoor soccer season

Recruitment start date

01/04/2011

Recruitment end date

30/09/2011

Locations

Countries of recruitment

Canada

Trial participating centre

University of Calgary
Calgary
T2N 1N4
Canada

Sponsor information

Organisation

Federation Internationale de Football Association [FIFA] (Switzerland)

Sponsor details

c/o Jiri Dvorack
FIFA Chief Medical Officer
Schulthess Clinic Zurich
Lengghalde 2
Zurich
8008
Switzerland

Sponsor type

Other

Website

http://www.fifa.com/

Funders

Funder type

Other

Funder name

Federation Internationale de Football Association [FIFA] (Switzerland)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23486935

Publication citations

  1. Results

    Steffen K, Meeuwisse WH, Romiti M, Kang J, McKay C, Bizzini M, Dvorak J, Finch C, Myklebust G, Emery CA, Evaluation of how different implementation strategies of an injury prevention programme (FIFA 11+) impact team adherence and injury risk in Canadian female youth football players: a cluster-randomised trial., Br J Sports Med, 2013, 47, 8, 480-487, doi: 10.1136/bjsports-2012-091887.

Additional files

Editorial Notes