Football Injuries in Children Clinical Trial
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.
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.
| Status | Enrolling by invitation |
| Enrollment | 6000 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 9 Years to 12 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - a structured warm-up focusing on neuromuscular control or an existing injury prevention programme is already performed |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department of Sport, Exercise and Health, University of Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University of Basel | Charles University, Czech Republic, FIFA-Medical Assessment and Research Centre (F-MARC), Saarland University, VU University of Amsterdam |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall injury rate | up to 12 months | Yes | |
| Secondary | Rate of severe injuries and acute injuries | up to 12 months | Yes |