<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/NCT03307434</url>
  </required_header>
  <id_info>
    <org_study_id>1708116</org_study_id>
    <secondary_id>ID-RCB</secondary_id>
    <nct_id>NCT03307434</nct_id>
  </id_info>
  <brief_title>To Evaluate the Effectiveness of an Injury Prevention Program in Athletics</brief_title>
  <acronym>PREVATHLE</acronym>
  <official_title>PREVATHLE: To Evaluate the Effectiveness of an Injury Prevention Program in Athletics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred&#xD;
      at least one injury during a season. The prevention of Athletics injuries thus represents a&#xD;
      major challenge for all stakeholders around athletes. In team sports, injury prevention&#xD;
      programs have been implemented and scientifically validated. However, no injury prevention&#xD;
      programs have been implemented and scientifically validated for Athletics. In this context, a&#xD;
      primary objective will be to analyze the effectiveness of an Athletics Injury Prevention&#xD;
      Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one&#xD;
      injury complaint related to athletic practice at long term (40 weeks). A statistician will&#xD;
      carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP),&#xD;
      multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs&#xD;
      and followed during an athletic season.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The person in charge of the platform will collect on a weekly basis via a IT-questionnaire&#xD;
      sent out automatically every Monday the following parameters: injury complaints (presence or&#xD;
      absence, and characteristics if presence) and exposure (number of hours of athletic practice&#xD;
      (training and competition) and intensity), and the number of AIPP realization per week. The&#xD;
      main criterion will be the frequency (percentage) of athletes presenting at least one injury&#xD;
      complaint that have a consequence on the practice (reduction or cessation of practice).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">July 29, 2018</completion_date>
  <primary_completion_date type="Actual">July 29, 2018</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>injury complaint and have a consequence on the practice</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>Frequency of athletes presenting at least one injury complaint and have a consequence on the practice (reduction or cessation of practice).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>injury complaint number and hours number of athletic practice</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>Correlation between injury complaint number and hours number of athletic practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>injury complaint number and weeks number of athletic practice</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>Correlation between injury complaint number and weeks number of athletic practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>week without injury complaints</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>Frequency of week without injury complaints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>injury complaint number at the training</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>Frequency of injury complaint number at the training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>injury complaint number and at the competition</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>Frequency of injury complaint number at the competition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>type of injury complaint between 4 consequences</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>the 4 consequences of injury complaint are : No consequence of athletic practice; reduce practice; Stop practice; and Consequence of practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>injury complaint number by groups</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>Correlation of injury complaint number by groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>injury complaint type</measure>
    <time_frame>at 40 weeks</time_frame>
    <description>Number of injury complaint type: hamstrings, Achilles tendons, ankles, knees and rachis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">880</enrollment>
  <condition>Athletics</condition>
  <condition>Wounds and Injuries</condition>
  <condition>Prevention Program</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>experimental group is composed of athletes will be followed the Athletics Injury Prevention Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control group is composed of athletes will be continued their regular training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Athletics Injury Prevention Program</intervention_name>
    <description>The Athletics Injury Prevention Program (AIPP) will be performed by experimental group twice a week. The AIPP is composed of 8 exercises including core stability, balance, pelvic stabilization, stretching and strengthening of the Achilles tendon and hamstrings.</description>
    <arm_group_label>experimental group</arm_group_label>
    <other_name>AIPP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>regular training</intervention_name>
    <description>The regular training will be performed by control group according to the standard practice.</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>standard practice</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To dismissed in athletics clubs affiliated to French Federation of Athletics&#xD;
&#xD;
          -  To practice one of the disciplines of athletics&#xD;
&#xD;
          -  Men or women aged between 15 and 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patient's refusal to participate in the study and / or inability to express agreement or&#xD;
        signing the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascal EDOUARD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Program</keyword>
  <keyword>Prevention</keyword>
  <keyword>Injury</keyword>
  <keyword>Athletics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03307434
org study id: 1708116
secondary id: ID-RCB
nct id: NCT03307434
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred
      at least one injury during a season. The prevention of Athletics injuries thus represents a
      major challenge for all stakeholders around athletes. In team sports, injury prevention
      programs have been implemented and scientifically validated. However, no injury prevention
      programs have been implemented and scientifically validated for Athletics. In this context, a
      primary objective will be to analyze the effectiveness of an Athletics Injury Prevention
      Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one
      injury complaint related to athletic practice at long term (40 weeks). A statistician will
      carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP),
      multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs
      and followed during an athletic season.
The person in charge of the platform will collect on a weekly basis via a IT-questionnaire
      sent out automatically every Monday the following parameters: injury complaints (presence or
      absence, and characteristics if presence) and exposure (number of hours of athletic practice
      (training and competition) and intensity), and the number of AIPP realization per week. The
      main criterion will be the frequency (percentage) of athletes presenting at least one injury
      complaint that have a consequence on the practice (reduction or cessation of practice).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: injury complaint and have a consequence on the practice
time frame: at 40 weeks
description: Frequency of athletes presenting at least one injury complaint and have a consequence on the practice (reduction or cessation of practice).
measure: injury complaint number and hours number of athletic practice
time frame: at 40 weeks
description: Correlation between injury complaint number and hours number of athletic practice
measure: injury complaint number and weeks number of athletic practice
time frame: at 40 weeks
description: Correlation between injury complaint number and weeks number of athletic practice
measure: week without injury complaints
time frame: at 40 weeks
description: Frequency of week without injury complaints
measure: injury complaint number at the training
time frame: at 40 weeks
description: Frequency of injury complaint number at the training
measure: injury complaint number and at the competition
time frame: at 40 weeks
description: Frequency of injury complaint number at the competition
measure: type of injury complaint between 4 consequences
time frame: at 40 weeks
description: the 4 consequences of injury complaint are : No consequence of athletic practice; reduce practice; Stop practice; and Consequence of practice
measure: injury complaint number by groups
time frame: at 40 weeks
description: Correlation of injury complaint number by groups
measure: injury complaint type
time frame: at 40 weeks
description: Number of injury complaint type: hamstrings, Achilles tendons, ankles, knees and rachis
arm group label: experimental group
arm group type: Experimental
description: experimental group is composed of athletes will be followed the Athletics Injury Prevention Program
arm group label: control group
arm group type: Active Comparator
description: control group is composed of athletes will be continued their regular training
intervention type: Other
intervention name: Athletics Injury Prevention Program
description: The Athletics Injury Prevention Program (AIPP) will be performed by experimental group twice a week. The AIPP is composed of 8 exercises including core stability, balance, pelvic stabilization, stretching and strengthening of the Achilles tendon and hamstrings.
arm group label: experimental group
other name: AIPP
intervention type: Other
intervention name: regular training
description: The regular training will be performed by control group according to the standard practice.
arm group label: control group
other name: standard practice
criteria: 
gender: All
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pascal EDOUARD, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No