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Football Injuries in ChildrenNCT02222025

Injury Prevention in Children´s Football

A study testing Injury Prevention Programme in people with Football Injuries in Children, run by University of Basel at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Playing football can induce considerable beneficial health effects, but is also a high-intensity and high-impact sport with many situations of direct contact between players which bear the risk of injury. Read more about this study

Who is it for?
Ages 9 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Football Injuries in Children
What is being tested?
Injury Prevention Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,895 participants
Where
1 siteSwitzerland
Study dates
Aug 2014to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • officially registered football club in the regional football association,
  • children must be between 9 and 12 years old at the start of the study
  • regular training must take place at least twice per week

Who cannot join

  • a structured warm-up focusing on neuromuscular control or an existing injury prevention programme is already performed

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Sport, Exercise and Health, University of Basel

    Basel, 4052

Other trials in Switzerland

About this study

Official title: Injury Prevention in Children´s Football (FIFA 11+ Kids): a Cluster-randomized Controlled Trial

Playing football can induce considerable beneficial health effects, but is also a high-intensity and high-impact sport with many situations of direct contact between players which bear the risk of injury. Thus, it is necessary to implement preventive measures to reduce the risk of injury and support the health benefits.

Injury characteristics of players older than 13 years are similar to adult players and, thus, similar preventive measures are beneficial. Younger players seem to show partly different injury characteristics. Consequently, preventive programmes proven effective in late adolescent or adult players need to be adapted for younger age groups. To date, no study investigated the prevention of football injuries in children under the age of 13 years.

Read more

We aim to assess the effectiveness of an exercise-based prevention program to reduce football-related injuries in children younger than 13 years.

The primary outcome in this study is the overall injury rate. Secondary outcomes are the rate of severe injuries and acute injuries.

The study is designed as a two-armed cluster-randomized controlled trial. We will recruit 9 to 12 years old children (boys and girls, born 2002 to 2005) participating in regular training and match play in an officially registered football club in Switzerland (further study centres are located in the Netherlands, Germany and the Czech Republic). The chosen age group is usually subdivided into two age categories (9/10 years, 11/12 years).

Recruitment will take place via the national and regional football associations.

Inclusion criteria are: the clubs must be officially registered in the regional football association, children must be between 9 and 12 years old at the start of the study and regular training must take place at least twice per week. Teams will be excluded, if the coaches already perform a structured warm-up focusing on neuromuscular control or an existing injury prevention programme.

Injury surveillance will include a baseline questionnaire, players´ exposure and injury registration. Anthropometric baseline data and information regarding previous football-related injuries will be obtained prior to the start of the study from the parents. Injury and exposure surveillance will be assisted by an automated internet-based injury recording system which has been developed and applied during our own epidemiological project.

For all participating teams, one contact person will be appointed. Those persons will be provided with exact instructions on injury definitions as well as examples how to complete the injury and exposure forms within the online injury recording system.

If an injury occurred, one trained person will contact the coach as well as the player and the parents by telephone and/or e-mail to assess all relevant aspects of the injury based on a standardized injury registration form. In case of injuries which require medical treatment parents will be supported to receive the exact diagnosis from the attending physician (either as specific written diagnosis or by use of a specific injury coding system). Two blinded investigators will additionally assess all information with regard to each injury to allow for objective and independent injury surveillance.

20 study assistants and 4 scientific assistants will support coaches with data collection and injury recording. Each study assistant will be responsible for eight clubs. Study assistant will regularly keep in touch with the clubs and will visit two training sessions of each team during the study period.

The intervention period will last one complete season. The injury prevention program will be included at the beginning of the usual football training by replacing the traditional warm-up. The programme will be conducted at least two times a week by the intervention teams. The prevention programme contains seven exercises and lasts about 10 to 15 min after familiarisation. Three exercises focus on unilateral, dynamic stability of the lower extremities (hopping, jumping and landing). Further, three exercises emphasize whole body and trunk stability. The last exercise contains rolling movements to improve fall technique.

The coaches of the control group will receive the instruction to regularly perform a common warm-up consisting of running and ball-based exercises (sham treatment, no neuromuscular and stability exercises).

The yearly incidence injured players in children is 8.6%. A risk reduction of one third has been recently acknowledged as a relevant effect size for injury rate. This corresponds to a reduction of the yearly incidence to 5.8% injured players. In order to achieve a statistical power of 80% and taking an allocation ratio of 1:1 and a cluster-inflation factor of 1.7 into account, in total 4´000 players are needed for statistical analysis. Assuming a realistic drop-out rate of about 33%, 6´000 children will be initially recruited.

Being tested
Injury Prevention Programme

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injury Prevention ProgrammeOther

    The injury prevention program will be included at the beginning of the usual football training by replacing the traditional warm-up. The programme will be conducted by the coaches at least two times a week (with exception of school holidays). The prevention programme contains seven exercises and lasts about 15 min after familiarisation. Three exercises focus on unilateral, dynamic stability of the lower extremities (hopping, jumping and landing). Further, three exercises emphasize whole body and trunk stability. The last exercise contains rolling movements to improve fall technique. The difficulty of each exercise can be progressively increased in five steps. Players start at the level of difficulty which corresponds to their current performance level. They will proceed to the next level when they perform the exercises with good control. This will be assessed by the coaches.

Study groups in NCT02222025
Study groupRoleWhat they receive
Injury Prevention ProgrammeExperimentalsee intervention prescription
Receives: Other: Injury Prevention Programme
ControlNo interventionThe coaches of the control group will receive the instruction to regularly perform a common warm-up consisting of running and ball-based exercises (sham treatment, no neuromuscular and stability exercises).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall injury rate

    Measured: up to 12 months

Secondary outcomes (1)
  1. Rate of severe injuries and acute injuries

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,895 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02222025
Sponsor's protocol ID
2014-232
Status last verified
Apr 2016
First submitted
14 Aug 2014
Last updated
22 Apr 2016
Results posted
No

Publications

  • Beaudouin F, Rossler R, Aus der Funten K, Bizzini M, Chomiak J, Verhagen E, Junge A, Dvorak J, Lichtenstein E, Meyer T, Faude O. Effects of the '11+ Kids' injury prevention programme on severe injuries in children's football: a secondary analysis of data from a multicentre cluster-randomised controlled trial. Br J Sports Med. 2019 Nov;53(22):1418-1423. doi: 10.1136/bjsports-2018-099062. Epub 2018 Oct 2.

    PubMed 30279219
  • Rossler R, Junge A, Bizzini M, Verhagen E, Chomiak J, Aus der Funten K, Meyer T, Dvorak J, Lichtenstein E, Beaudouin F, Faude O. A Multinational Cluster Randomised Controlled Trial to Assess the Efficacy of '11+ Kids': A Warm-Up Programme to Prevent Injuries in Children's Football. Sports Med. 2018 Jun;48(6):1493-1504. doi: 10.1007/s40279-017-0834-8.

    PubMed 29273936

Questions about this trial

What is this clinical trial studying?

A study testing Injury Prevention Programme in people with Football Injuries in Children, run by University of Basel at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall injury rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02222025, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.

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