<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/NCT03251404</url>
  </required_header>
  <id_info>
    <org_study_id>MHägglundPerformance</org_study_id>
    <nct_id>NCT03251404</nct_id>
  </id_info>
  <brief_title>Effects of Injury Prevention Exercises on Performance and Neuromuscular Function</brief_title>
  <official_title>Effects of Two Injury Prevention Exercise Programs on Performance and Neuromuscular Function in Youth Football</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Swedish Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region Östergötland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effects of two different injury prevention exercise programs on&#xD;
      sports-relevant performance tests and neuromuscular function in youth football players. Half&#xD;
      of participants will receive education on an existing and previously tested exercise program,&#xD;
      while the other half will receive education on a newly developed exercise program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Injury prevention exercise programs have been developed for a variety of sporting contexts&#xD;
      and many have proven to be efficacious in preventing injuries. Adherence with the training&#xD;
      may, however, be an issue and poor adherence may limit the preventive effect. If using the&#xD;
      preventive exercise programs can be shown to improve sports-relevant performance this may&#xD;
      motivate both coaches and players to use these programs, since the reduction in injury risk&#xD;
      is harder to notice for the individual.&#xD;
&#xD;
      This study focuses on a Swedish injury prevention exercise program called Knee Control. The&#xD;
      program has been found efficacious in preventing acute knee injuries in girls' adolescent&#xD;
      football players in previous trials. We have found, however, that coaches often modify the&#xD;
      Knee Control program to improve program fit and player buy-in among female youth football&#xD;
      players. Careful changes must be made to the program since there is a risk of compromising&#xD;
      the preventive effect and the effect on performance if the training dose is too low or if&#xD;
      effective exercises are replaced with other exercises. We have therefore further developed&#xD;
      the Knee Control program, to a Knee Control+ program, to support the coaches in the tailoring&#xD;
      of the program to preserve the preventive effect and hopefully enhance performance effects.&#xD;
      By introducing more variation with easier and more difficult exercises, pair-exercises,&#xD;
      competitive and plyometric elements the new Knee Control+ program may better fit both the&#xD;
      youngest and the oldest players, which in turn may facilitate fidelity with and maintenance&#xD;
      of the program.&#xD;
&#xD;
      The aim of the study is to compare the neuromuscular and performance effects of the original&#xD;
      Knee Control and the new Knee Control+ programs among youth female and male football players.&#xD;
      A secondary aim is to study player and coach experiences of the programs and their fidelity&#xD;
      with the training protocol.&#xD;
&#xD;
      Hypothesis: We expect similar effects of both programs, or superior effects of the Knee&#xD;
      Control+ program, showing that the programs are compatible but the program adherence and&#xD;
      fidelity being better with Knee Control+.&#xD;
&#xD;
      Methods: Eight youth football teams (4 boys, 4 girls, age 13-17 years) with approximately 120&#xD;
      players will be included in the study. Four teams will receive education about the Knee&#xD;
      Control program and four teams about the Knee Control+ program. All coaches and two to three&#xD;
      players per team will take part in a workshop at baseline where registered physiotherapists&#xD;
      will give practical instructions of the intervention exercise programs. The workshops will&#xD;
      also contain theoretical information about injuries in football and the background for either&#xD;
      the Knee Control or the Knee Control+ programs. The attending coaches and players will be&#xD;
      able to test all exercises and receive feedback about correct movement technique.&#xD;
&#xD;
      Outcomes: Football-relevant performance and neuromuscular function will be tested at baseline&#xD;
      and after 12 weeks of training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2017</start_date>
  <completion_date type="Actual">November 26, 2017</completion_date>
  <primary_completion_date type="Actual">November 26, 2017</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>
    <intervention_model_description>Two-armed cluster randomized parallel trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessors (performance tests and neuromuscular function) blinded to group allocation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in performance on the agility t-test (s)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the single-leg hop for distance (m)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on drop vertical jumps as measured with knee separation distance (m)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the 505 agility test (s)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the side-hop test (n)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the 10 m sprint test (s)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on the 20 m sprint test (s)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in performance on evaluation of lower extremity landing technique during the tuck jump test (points)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coach baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coach reported compliance and fidelity with the program protocol</measure>
    <time_frame>At follow-up 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Player baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injuries that occur during the intervention period (number of injured players in each group)</measure>
    <time_frame>At follow-up 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Sport Injury</condition>
  <condition>Adherence, Patient</condition>
  <arm_group>
    <arm_group_label>Knee Control original</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Knee Control program exercise program will be performed during the warm-up to each football practice (at least twice per week) during the 12 week intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Knee Control+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Knee Control+ is an extension of the original Knee Control exercise program offering a wider selection of exercises (to increase adherence) and more physically challenging exercises (adapted for athletes in the late teens and provide further stimuli to increase player performance and neuromuscular function). The program will be performed during the warm-up to each football practice (at least twice per week) during the 12 week intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Injury prevention exercise programs</intervention_name>
    <description>The two intervention programs contain exercises aiming to increase lower extremity strength, core stability, balance and neuromuscular function.</description>
    <arm_group_label>Knee Control original</arm_group_label>
    <arm_group_label>Knee Control+</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Football teams who have training at least twice per week&#xD;
&#xD;
          -  Healthy players who can exert themselves maximally during testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Teams who have used the Knee Control or a similar injury prevention exercise program&#xD;
             on a regular basis the last year&#xD;
&#xD;
          -  Players who cannot take full part in measurements due to illnesses or injuries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Hägglund, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of physiotherapy, Department of Medical and Health Sciences, Linköping University</name>
      <address>
        <city>Linköping</city>
        <zip>58183</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 26, 2018</last_update_submitted>
  <last_update_submitted_qc>February 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Martin Hägglund</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Athletic Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Study data (de-identified player performance test scores) may be available at request from the principal investigator</ipd_description>
  </patient_data>
  <!-- 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/NCT03251404
org study id: MHägglundPerformance
nct id: NCT03251404
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effects of two different injury prevention exercise programs on
      sports-relevant performance tests and neuromuscular function in youth football players. Half
      of participants will receive education on an existing and previously tested exercise program,
      while the other half will receive education on a newly developed exercise program.
Injury prevention exercise programs have been developed for a variety of sporting contexts
      and many have proven to be efficacious in preventing injuries. Adherence with the training
      may, however, be an issue and poor adherence may limit the preventive effect. If using the
      preventive exercise programs can be shown to improve sports-relevant performance this may
      motivate both coaches and players to use these programs, since the reduction in injury risk
      is harder to notice for the individual.

      This study focuses on a Swedish injury prevention exercise program called Knee Control. The
      program has been found efficacious in preventing acute knee injuries in girls' adolescent
      football players in previous trials. We have found, however, that coaches often modify the
      Knee Control program to improve program fit and player buy-in among female youth football
      players. Careful changes must be made to the program since there is a risk of compromising
      the preventive effect and the effect on performance if the training dose is too low or if
      effective exercises are replaced with other exercises. We have therefore further developed
      the Knee Control program, to a Knee Control+ program, to support the coaches in the tailoring
      of the program to preserve the preventive effect and hopefully enhance performance effects.
      By introducing more variation with easier and more difficult exercises, pair-exercises,
      competitive and plyometric elements the new Knee Control+ program may better fit both the
      youngest and the oldest players, which in turn may facilitate fidelity with and maintenance
      of the program.

      The aim of the study is to compare the neuromuscular and performance effects of the original
      Knee Control and the new Knee Control+ programs among youth female and male football players.
      A secondary aim is to study player and coach experiences of the programs and their fidelity
      with the training protocol.

      Hypothesis: We expect similar effects of both programs, or superior effects of the Knee
      Control+ program, showing that the programs are compatible but the program adherence and
      fidelity being better with Knee Control+.

      Methods: Eight youth football teams (4 boys, 4 girls, age 13-17 years) with approximately 120
      players will be included in the study. Four teams will receive education about the Knee
      Control program and four teams about the Knee Control+ program. All coaches and two to three
      players per team will take part in a workshop at baseline where registered physiotherapists
      will give practical instructions of the intervention exercise programs. The workshops will
      also contain theoretical information about injuries in football and the background for either
      the Knee Control or the Knee Control+ programs. The attending coaches and players will be
      able to test all exercises and receive feedback about correct movement technique.

      Outcomes: Football-relevant performance and neuromuscular function will be tested at baseline
      and after 12 weeks of training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-armed cluster randomized parallel trial
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Outcomes assessors (performance tests and neuromuscular function) blinded to group allocation
measure: Change in performance on the agility t-test (s)
time frame: Baseline and 12 weeks
measure: Change in performance on the single-leg hop for distance (m)
time frame: Baseline and 12 weeks
measure: Change in performance on drop vertical jumps as measured with knee separation distance (m)
time frame: Baseline and 12 weeks
measure: Change in performance on the 505 agility test (s)
time frame: Baseline and 12 weeks
measure: Change in performance on the side-hop test (n)
time frame: Baseline and 12 weeks
measure: Change in performance on the 10 m sprint test (s)
time frame: Baseline and 12 weeks
measure: Change in performance on the 20 m sprint test (s)
time frame: Baseline and 12 weeks
measure: Change in performance on evaluation of lower extremity landing technique during the tuck jump test (points)
time frame: Baseline and 12 weeks
measure: Coach baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs
time frame: Baseline and 12 weeks
measure: Coach reported compliance and fidelity with the program protocol
time frame: At follow-up 12 weeks
measure: Player baseline and follow-up experiences of injuries and of the Knee Control and Knee Control+ programs
time frame: Baseline and 12 weeks
measure: Injuries that occur during the intervention period (number of injured players in each group)
time frame: At follow-up 12 weeks
arm group label: Knee Control original
arm group type: Active Comparator
description: The Knee Control program exercise program will be performed during the warm-up to each football practice (at least twice per week) during the 12 week intervention period.
arm group label: Knee Control+
arm group type: Experimental
description: The Knee Control+ is an extension of the original Knee Control exercise program offering a wider selection of exercises (to increase adherence) and more physically challenging exercises (adapted for athletes in the late teens and provide further stimuli to increase player performance and neuromuscular function). The program will be performed during the warm-up to each football practice (at least twice per week) during the 12 week intervention period.
intervention type: Other
intervention name: Injury prevention exercise programs
description: The two intervention programs contain exercises aiming to increase lower extremity strength, core stability, balance and neuromuscular function.
arm group label: Knee Control original
arm group label: Knee Control+
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Hägglund, PhD
role: Principal Investigator
affiliation: Linkoeping University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Martin Hägglund
investigator title: Associate professor
mesh term: Wounds and Injuries
mesh term: Athletic Injuries
sharing ipd: Undecided
ipd description: Study data (de-identified player performance test scores) may be available at request from the principal investigator