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Injury Prevention in Children´s Football

Primary Purpose

Football Injuries in Children

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Injury Prevention Programme
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Football Injuries in Children

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Injury Prevention Programme

Control

Arm Description

see intervention prescription

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).

Outcomes

Primary Outcome Measures

Overall injury rate

Secondary Outcome Measures

Rate of severe injuries and acute injuries

Full Information

First Posted
August 14, 2014
Last Updated
April 21, 2016
Sponsor
University of Basel
Collaborators
VU University of Amsterdam, Charles University, Czech Republic, Universität des Saarlandes, FIFA-Medical Assessment and Research Centre (F-MARC)
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1. Study Identification

Unique Protocol Identification Number
NCT02222025
Brief Title
Injury Prevention in Children´s Football
Official Title
Injury Prevention in Children´s Football (FIFA 11+ Kids): a Cluster-randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Basel
Collaborators
VU University of Amsterdam, Charles University, Czech Republic, Universität des Saarlandes, FIFA-Medical Assessment and Research Centre (F-MARC)

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Football Injuries in Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3895 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injury Prevention Programme
Arm Type
Experimental
Arm Description
see intervention prescription
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Injury Prevention Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall injury rate
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Rate of severe injuries and acute injuries
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Sport, Exercise and Health, University of Basel
City
Basel
ZIP/Postal Code
4052
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30279219
Citation
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.
Results Reference
derived
PubMed Identifier
29273936
Citation
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.
Results Reference
derived

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Injury Prevention in Children´s Football

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