<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/NCT02999139</url>
  </required_header>
  <id_info>
    <org_study_id>P00023758</org_study_id>
    <nct_id>NCT02999139</nct_id>
  </id_info>
  <brief_title>Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention</brief_title>
  <official_title>Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <brief_summary>
    <textblock>
      Participants who train at The Micheli Center for Sports Injury Prevention, will undergo&#xD;
      testing of muscular strength, range of motion, flexibility, aerobic capacity and muscular&#xD;
      endurance. They will complete training with a certified trainer and injury prevention&#xD;
      specialist until their specific goals are meet. Upon completion of training, they will fill&#xD;
      out an injury questionnaire every three months for five to ten years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2016</start_date>
  <completion_date type="Actual">December 29, 2021</completion_date>
  <primary_completion_date type="Actual">December 29, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Injury</measure>
    <time_frame>After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.</time_frame>
    <description>For purposes of our study, an injury is one that:&#xD;
occurred as a result of participation in sport AND&#xD;
required medical attention by a team athletic trainer or a physician AND&#xD;
resulted in restriction of the student-athlete's participation for one or more days beyond the day of injury OR&#xD;
resulted in any fracture, concussion, or dental injury regardless of whether or not it resulted in restriction of the student-athlete's participation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Training Habits</measure>
    <time_frame>After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.</time_frame>
    <description>Surveys will answer if participants continue with their new training habits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular Strength</measure>
    <time_frame>Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.</time_frame>
    <description>This will be measured by hand held dynamometer pre and post training intervention. Will testing major muscles such as the quadriceps, hamstrings, biceps, triceps.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aerobic Capacity</measure>
    <time_frame>Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.</time_frame>
    <description>This will be estimated by the step test, done pre and post training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anaerobic Capacity</measure>
    <time_frame>Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.</time_frame>
    <description>This will be measured by a series of tests such as the vertical jump test and shuttle run. These measures will be tested pre and post training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.</time_frame>
    <description>This will be measured by goniometer at different joints such as the knee and ankle pre and post training.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">633</enrollment>
  <condition>Exercise Training</condition>
  <arm_group>
    <arm_group_label>ACL Return to Play</arm_group_label>
    <description>A specific training program, with emphasis on hamstring strengthening. There will also be a specificity on pivoting and jumping safely.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gait Retraining</arm_group_label>
    <description>Will receive training that is specific to running. Drills will help enforce a more efficient running form, as well as strengthening important muscle groups such as the hip abductors and adductors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Private Training</arm_group_label>
    <description>Participants will receive a broad training program, targeting all major muscle groups. The goal is to increase muscle strength, mobility and aerobic capacity to reduce the risk of injury.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male and females age 6 and over.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males, Females, age 6 and over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 6 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Micheli Center for Sports Injury Prevention</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Daisuke Sugimoto</investigator_full_name>
    <investigator_title>Lead Research Technologist</investigator_title>
  </responsible_party>
  <keyword>Injury</keyword>
  <keyword>Prevention</keyword>
  <!-- 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/NCT02999139
org study id: P00023758
nct id: NCT02999139
lead sponsor: 
Participants who train at The Micheli Center for Sports Injury Prevention, will undergo
      testing of muscular strength, range of motion, flexibility, aerobic capacity and muscular
      endurance. They will complete training with a certified trainer and injury prevention
      specialist until their specific goals are meet. Upon completion of training, they will fill
      out an injury questionnaire every three months for five to ten years.
observational model: Cohort
time perspective: Prospective
measure: Injury
time frame: After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.
description: For purposes of our study, an injury is one that:
occurred as a result of participation in sport AND
required medical attention by a team athletic trainer or a physician AND
resulted in restriction of the student-athlete's participation for one or more days beyond the day of injury OR
resulted in any fracture, concussion, or dental injury regardless of whether or not it resulted in restriction of the student-athlete's participation
measure: Training Habits
time frame: After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.
description: Surveys will answer if participants continue with their new training habits
measure: Muscular Strength
time frame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
description: This will be measured by hand held dynamometer pre and post training intervention. Will testing major muscles such as the quadriceps, hamstrings, biceps, triceps.
measure: Aerobic Capacity
time frame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
description: This will be estimated by the step test, done pre and post training.
measure: Anaerobic Capacity
time frame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
description: This will be measured by a series of tests such as the vertical jump test and shuttle run. These measures will be tested pre and post training.
measure: Range of Motion
time frame: Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.
description: This will be measured by goniometer at different joints such as the knee and ankle pre and post training.
arm group label: ACL Return to Play
description: A specific training program, with emphasis on hamstring strengthening. There will also be a specificity on pivoting and jumping safely.
arm group label: Gait Retraining
description: Will receive training that is specific to running. Drills will help enforce a more efficient running form, as well as strengthening important muscle groups such as the hip abductors and adductors.
arm group label: Private Training
description: Participants will receive a broad training program, targeting all major muscle groups. The goal is to increase muscle strength, mobility and aerobic capacity to reduce the risk of injury.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Daisuke Sugimoto
investigator title: Lead Research Technologist