<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/NCT03293121</url>
  </required_header>
  <id_info>
    <org_study_id>HM20010685</org_study_id>
    <nct_id>NCT03293121</nct_id>
  </id_info>
  <brief_title>Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners</brief_title>
  <official_title>Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that new runners participating in an 8 week strength and&#xD;
      coordination training program prior to beginning to run will 1) display different&#xD;
      coordination patterns , and 2) experience fewer injuries, compared to new runners who do not&#xD;
      perform strength or coordination training prior to running.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will investigate the effect of a sequenced training program - beginning with&#xD;
      strength training, followed by running-specific coordination exercises, and finally a gradual&#xD;
      introduction to running - on strength, coordination and injury incidence in a group of novice&#xD;
      runners. he investigators hypothesize that runners who perform strength and coordination&#xD;
      training prior to beginning to run will 1) demonstrate greater lower extremity strength, 2)&#xD;
      demonstrate alters coordination patterns and 3) experience fewer injuries, when compared to a&#xD;
      control group of novice runners who perform no physical preparation prior to a gradual&#xD;
      introduction to running. The possible long-term benefits of this study include reduced burden&#xD;
      of running-related injuries, increased participation in the sport of running, improved&#xD;
      cardiovascular and metabolic health characteristics, and reduced incidence of disease such as&#xD;
      cardiovascular events and cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">June 4, 2018</completion_date>
  <primary_completion_date type="Actual">June 4, 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>Running biomechanics</measure>
    <time_frame>Change from week 0 to week 16</time_frame>
    <description>Relative joint motions will be assessed continuously throughout the stride cycle using a vector coding technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Running injury.</measure>
    <time_frame>Measured in days over the 16 week training period.</time_frame>
    <description>Time to first running related injury.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Running performance</measure>
    <time_frame>16 weeks</time_frame>
    <description>5km time trial at the end of 16 weeks training.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Injuries</condition>
  <condition>Patellofemoral Pain Syndrome</condition>
  <condition>Iliotibial Band Syndrome</condition>
  <arm_group>
    <arm_group_label>Strength and Coordination Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The strength and coordination group will perform a progression of exercises utilizing body weight and resistance bands as resistance. Exercises include squats, lunges, jumps etc. typical of a normal strength training program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The walking group will be instructed to walk 3x/week, progressing from 30 to 45 min over 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strength and Coordination Training</intervention_name>
    <description>Perform training exercises 3/week. Weeks 1-2: general strength (isolated muscle groups) Weeks 3-4: running-specific strength (multi-joint, upright) Weeks 5-6: power/coordination I (low amplitude/intensity) Weeks 7-8: power/coordination II (higher amplitude/intensity) Weeks 9-16: Run training. Each training session will start with a 10 minute strength &amp; coordination warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.</description>
    <arm_group_label>Strength and Coordination Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking</intervention_name>
    <description>Perform training exercises 3/week. Weeks 1-2: 30 minute walk Weeks 3-4: 35 minute walk Weeks 5-6: 40 minute walk Weeks 7-8: 45 minute walk Weeks 9-16: Run training. Each training session will start with a 10 minute walking warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.</description>
    <arm_group_label>Walking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No previous participation in running races&#xD;
&#xD;
          -  Run less than 10km total in past year&#xD;
&#xD;
          -  Able to run continuously (ie at least 5mph) for 5 min (so that biomechanical analysis&#xD;
             of running form can be conducted)&#xD;
&#xD;
          -  Female participants may not be pregnant&#xD;
&#xD;
          -  Participants will be screened using the PARQ+ form, and Parmed-X form completed by a&#xD;
             physician if necessary&#xD;
&#xD;
          -  Cleared for physical activity through screening&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous (at any time of life) training of 3 or months of consistently running 3 or&#xD;
             more days per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheryl Finucane, PT, PhD, CEEAA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>running related injuries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Iliotibial Band Syndrome</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/NCT03293121
org study id: HM20010685
nct id: NCT03293121
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that new runners participating in an 8 week strength and
      coordination training program prior to beginning to run will 1) display different
      coordination patterns , and 2) experience fewer injuries, compared to new runners who do not
      perform strength or coordination training prior to running.
The study will investigate the effect of a sequenced training program - beginning with
      strength training, followed by running-specific coordination exercises, and finally a gradual
      introduction to running - on strength, coordination and injury incidence in a group of novice
      runners. he investigators hypothesize that runners who perform strength and coordination
      training prior to beginning to run will 1) demonstrate greater lower extremity strength, 2)
      demonstrate alters coordination patterns and 3) experience fewer injuries, when compared to a
      control group of novice runners who perform no physical preparation prior to a gradual
      introduction to running. The possible long-term benefits of this study include reduced burden
      of running-related injuries, increased participation in the sport of running, improved
      cardiovascular and metabolic health characteristics, and reduced incidence of disease such as
      cardiovascular events and cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Running biomechanics
time frame: Change from week 0 to week 16
description: Relative joint motions will be assessed continuously throughout the stride cycle using a vector coding technique.
measure: Running injury.
time frame: Measured in days over the 16 week training period.
description: Time to first running related injury.
measure: Running performance
time frame: 16 weeks
description: 5km time trial at the end of 16 weeks training.
arm group label: Strength and Coordination Training
arm group type: Experimental
description: The strength and coordination group will perform a progression of exercises utilizing body weight and resistance bands as resistance. Exercises include squats, lunges, jumps etc. typical of a normal strength training program.
arm group label: Walking
arm group type: Active Comparator
description: The walking group will be instructed to walk 3x/week, progressing from 30 to 45 min over 8 weeks.
intervention type: Behavioral
intervention name: Strength and Coordination Training
description: Perform training exercises 3/week. Weeks 1-2: general strength (isolated muscle groups) Weeks 3-4: running-specific strength (multi-joint, upright) Weeks 5-6: power/coordination I (low amplitude/intensity) Weeks 7-8: power/coordination II (higher amplitude/intensity) Weeks 9-16: Run training. Each training session will start with a 10 minute strength & coordination warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.
arm group label: Strength and Coordination Training
intervention type: Behavioral
intervention name: Walking
description: Perform training exercises 3/week. Weeks 1-2: 30 minute walk Weeks 3-4: 35 minute walk Weeks 5-6: 40 minute walk Weeks 7-8: 45 minute walk Weeks 9-16: Run training. Each training session will start with a 10 minute walking warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.
arm group label: Walking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sheryl Finucane, PT, PhD, CEEAA
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Patellofemoral Pain Syndrome
mesh term: Syndrome
mesh term: Wounds and Injuries
mesh term: Iliotibial Band Syndrome