<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02222025</url>
  </required_header>
  <id_info>
    <org_study_id>2014-232</org_study_id>
    <nct_id>NCT02222025</nct_id>
  </id_info>
  <brief_title>Injury Prevention in Children´s Football</brief_title>
  <official_title>Injury Prevention in Children´s Football (FIFA 11+ Kids): a Cluster-randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Basel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VU University of Amsterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universität des Saarlandes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>FIFA-Medical Assessment and Research Centre (F-MARC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Basel</source>
  <brief_summary>
    <textblock>
      Playing football can induce considerable beneficial health effects, but is also a&#xD;
      high-intensity and high-impact sport with many situations of direct contact between players&#xD;
      which bear the risk of injury. Thus, it is necessary to implement preventive measures to&#xD;
      reduce the risk of injury and support the health benefits.&#xD;
&#xD;
      Injury characteristics of players older than 13 years are similar to adult players and, thus,&#xD;
      similar preventive measures are beneficial. Younger players seem to show partly different&#xD;
      injury characteristics. Consequently, preventive programmes proven effective in late&#xD;
      adolescent or adult players need to be adapted for younger age groups. To date, no study&#xD;
      investigated the prevention of football injuries in children under the age of 13 years.&#xD;
&#xD;
      We aim to assess the effectiveness of an exercise-based prevention program to reduce&#xD;
      football-related injuries in children younger than 13 years.&#xD;
&#xD;
      The primary outcome in this study is the overall injury rate. Secondary outcomes are the rate&#xD;
      of severe injuries and acute injuries.&#xD;
&#xD;
      The study is designed as a two-armed cluster-randomized controlled trial. We will recruit 9&#xD;
      to 12 years old children (boys and girls, born 2002 to 2005) participating in regular&#xD;
      training and match play in an officially registered football club in Switzerland (further&#xD;
      study centres are located in the Netherlands, Germany and the Czech Republic). The chosen age&#xD;
      group is usually subdivided into two age categories (9/10 years, 11/12 years).&#xD;
&#xD;
      Recruitment will take place via the national and regional football associations.&#xD;
&#xD;
      Inclusion criteria are: the clubs must be officially registered in the regional football&#xD;
      association, children must be between 9 and 12 years old at the start of the study and&#xD;
      regular training must take place at least twice per week. Teams will be excluded, if the&#xD;
      coaches already perform a structured warm-up focusing on neuromuscular control or an existing&#xD;
      injury prevention programme.&#xD;
&#xD;
      Injury surveillance will include a baseline questionnaire, players´ exposure and injury&#xD;
      registration. Anthropometric baseline data and information regarding previous&#xD;
      football-related injuries will be obtained prior to the start of the study from the parents.&#xD;
      Injury and exposure surveillance will be assisted by an automated internet-based injury&#xD;
      recording system which has been developed and applied during our own epidemiological project.&#xD;
&#xD;
      For all participating teams, one contact person will be appointed. Those persons will be&#xD;
      provided with exact instructions on injury definitions as well as examples how to complete&#xD;
      the injury and exposure forms within the online injury recording system.&#xD;
&#xD;
      If an injury occurred, one trained person will contact the coach as well as the player and&#xD;
      the parents by telephone and/or e-mail to assess all relevant aspects of the injury based on&#xD;
      a standardized injury registration form. In case of injuries which require medical treatment&#xD;
      parents will be supported to receive the exact diagnosis from the attending physician (either&#xD;
      as specific written diagnosis or by use of a specific injury coding system). Two blinded&#xD;
      investigators will additionally assess all information with regard to each injury to allow&#xD;
      for objective and independent injury surveillance.&#xD;
&#xD;
      20 study assistants and 4 scientific assistants will support coaches with data collection and&#xD;
      injury recording. Each study assistant will be responsible for eight clubs. Study assistant&#xD;
      will regularly keep in touch with the clubs and will visit two training sessions of each team&#xD;
      during the study period.&#xD;
&#xD;
      The intervention period will last one complete season. The injury prevention program will be&#xD;
      included at the beginning of the usual football training by replacing the traditional&#xD;
      warm-up. The programme will be conducted at least two times a week by the intervention teams.&#xD;
      The prevention programme contains seven exercises and lasts about 10 to 15 min after&#xD;
      familiarisation. Three exercises focus on unilateral, dynamic stability of the lower&#xD;
      extremities (hopping, jumping and landing). Further, three exercises emphasize whole body and&#xD;
      trunk stability. The last exercise contains rolling movements to improve fall technique.&#xD;
&#xD;
      The coaches of the control group will receive the instruction to regularly perform a common&#xD;
      warm-up consisting of running and ball-based exercises (sham treatment, no neuromuscular and&#xD;
      stability exercises).&#xD;
&#xD;
      The yearly incidence injured players in children is 8.6%. A risk reduction of one third has&#xD;
      been recently acknowledged as a relevant effect size for injury rate. This corresponds to a&#xD;
      reduction of the yearly incidence to 5.8% injured players. In order to achieve a statistical&#xD;
      power of 80% and taking an allocation ratio of 1:1 and a cluster-inflation factor of 1.7 into&#xD;
      account, in total 4´000 players are needed for statistical analysis. Assuming a realistic&#xD;
      drop-out rate of about 33%, 6´000 children will be initially recruited.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall injury rate</measure>
    <time_frame>up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of severe injuries and acute injuries</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3895</enrollment>
  <condition>Football Injuries in Children</condition>
  <arm_group>
    <arm_group_label>Injury Prevention Programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>see intervention prescription</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Injury Prevention Programme</intervention_name>
    <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.</description>
    <arm_group_label>Injury Prevention Programme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  officially registered football club in the regional football association,&#xD;
&#xD;
          -  children must be between 9 and 12 years old at the start of the study&#xD;
&#xD;
          -  regular training must take place at least twice per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a structured warm-up focusing on neuromuscular control or an existing injury&#xD;
             prevention programme is already performed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Sport, Exercise and Health, University of Basel</name>
      <address>
        <city>Basel</city>
        <zip>4052</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>April 21, 2016</last_update_submitted>
  <last_update_submitted_qc>April 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Basel</investigator_affiliation>
    <investigator_full_name>Oliver Faude</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02222025
org study id: 2014-232
nct id: NCT02222025
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Overall injury rate
time frame: up to 12 months
measure: Rate of severe injuries and acute injuries
time frame: up to 12 months
arm group label: Injury Prevention Programme
arm group type: Experimental
description: see intervention prescription
arm group label: Control
arm group type: No Intervention
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: Injury Prevention Programme
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.
arm group label: Injury Prevention Programme
criteria: 
gender: All
minimum age: 9 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Basel
investigator full name: Oliver Faude
investigator title: Dr.
mesh term: Wounds and Injuries