<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/NCT03751150</url>
  </required_header>
  <id_info>
    <org_study_id>SahgrenskaUH</org_study_id>
    <nct_id>NCT03751150</nct_id>
  </id_info>
  <brief_title>Effectiveness of Injury Prevention Guidelines in Recreational Runners</brief_title>
  <official_title>Effectiveness of Injury Prevention Guidelines in Recreational Runners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</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 aim of this trial is to investigate the effectiveness of specific training programs on&#xD;
      the incidence of injuries in recreational runners. 408 runners between the ages of 18 and 55&#xD;
      years, will be recruited and randomly allocated to either the intervention group or control&#xD;
      group. The intervention group will perform the training program twice a week in addition to&#xD;
      their regular training. Injury data will be collected as the injuries occur and documentation&#xD;
      of injury will follow a predetermined definition of injury. Participants will submit weekly&#xD;
      reports of their running distance, frequency, running-related pain, as well as successful&#xD;
      performance of the assigned training program for the intervention groups. The primary outcome&#xD;
      is the incidence of injuries in all groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Injuries and especially overuse injuries within recreational running are a common occurrence&#xD;
      with higher incidence rates in novice runners but also in recreational runners training for a&#xD;
      specific event. The mechanisms behind overuse injury development are thought to be&#xD;
      multifactorial and certain parameters have shown to increase injury risk in recreational&#xD;
      runners. The aim of this trial is to target these specific parameters and implement training&#xD;
      programs to which recreational runners will adhere for a period of 18 weeks. About 408 male&#xD;
      and female recreational runners, aged 18-55 years will be randomly allocated to one either&#xD;
      the intervention (INT) or Control (CON).The INT group will perform an exercise program&#xD;
      containing muscle control and foamrolling exercises in addition to their regular training,&#xD;
      twice a week. The CON group will continue as per usual with their training. Training data&#xD;
      will be collected on a weekly basis from all groups and pain and injury information will be&#xD;
      submitted by the participants upon occurrence. The primary outcome measure is the number of&#xD;
      sustained injuries in both groups. Participants will be recruited in December 2018 and the&#xD;
      intervention will start in January 2019 for a period of 18 weeks, ending in May 2019. Data&#xD;
      analyses are anticipated to be completed in September 2019.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 30, 2021</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 occurence</measure>
    <time_frame>18 weeks</time_frame>
    <description>Incidence of running-related injuries</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Sports Injury</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Normal training, no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention INT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consists of an exercise program developed by a team specialised in orthopaedics, physiotherapy and biomechanics, based on the results from a recent prospective study in Gothenburg, Sweden. The exercises included cover muscle control training for the core, abductors, quadriceps and foot pronators, as well as foamrolling for the abductors, quadriceps, hamstrings, calf muscles and gluteal muscles. The runners will be instructed to perform the training program twice a week for the entire intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise program</intervention_name>
    <description>The runners will be asked to perform the training program twice a week. The intervention consist of muscle control and foam rolling exercises for the lower extremities.</description>
    <arm_group_label>Intervention INT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female recreational runners with an average weekly running distance&#xD;
             of at least 15km.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Injury to the lower extremities during the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jòn Karlsson, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefan Grau, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cenrte for Health and Performance</name>
      <address>
        <city>Gothenburg</city>
        <zip>41140</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Pia Desai</investigator_full_name>
    <investigator_title>Doctoral Student</investigator_title>
  </responsible_party>
  <keyword>Running-related injury</keyword>
  <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>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/NCT03751150
org study id: SahgrenskaUH
nct id: NCT03751150
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this trial is to investigate the effectiveness of specific training programs on
      the incidence of injuries in recreational runners. 408 runners between the ages of 18 and 55
      years, will be recruited and randomly allocated to either the intervention group or control
      group. The intervention group will perform the training program twice a week in addition to
      their regular training. Injury data will be collected as the injuries occur and documentation
      of injury will follow a predetermined definition of injury. Participants will submit weekly
      reports of their running distance, frequency, running-related pain, as well as successful
      performance of the assigned training program for the intervention groups. The primary outcome
      is the incidence of injuries in all groups.
Injuries and especially overuse injuries within recreational running are a common occurrence
      with higher incidence rates in novice runners but also in recreational runners training for a
      specific event. The mechanisms behind overuse injury development are thought to be
      multifactorial and certain parameters have shown to increase injury risk in recreational
      runners. The aim of this trial is to target these specific parameters and implement training
      programs to which recreational runners will adhere for a period of 18 weeks. About 408 male
      and female recreational runners, aged 18-55 years will be randomly allocated to one either
      the intervention (INT) or Control (CON).The INT group will perform an exercise program
      containing muscle control and foamrolling exercises in addition to their regular training,
      twice a week. The CON group will continue as per usual with their training. Training data
      will be collected on a weekly basis from all groups and pain and injury information will be
      submitted by the participants upon occurrence. The primary outcome measure is the number of
      sustained injuries in both groups. Participants will be recruited in December 2018 and the
      intervention will start in January 2019 for a period of 18 weeks, ending in May 2019. Data
      analyses are anticipated to be completed in September 2019.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Injury occurence
time frame: 18 weeks
description: Incidence of running-related injuries
arm group label: Control
arm group type: No Intervention
description: Normal training, no intervention
arm group label: Intervention INT
arm group type: Experimental
description: The intervention consists of an exercise program developed by a team specialised in orthopaedics, physiotherapy and biomechanics, based on the results from a recent prospective study in Gothenburg, Sweden. The exercises included cover muscle control training for the core, abductors, quadriceps and foot pronators, as well as foamrolling for the abductors, quadriceps, hamstrings, calf muscles and gluteal muscles. The runners will be instructed to perform the training program twice a week for the entire intervention period.
intervention type: Other
intervention name: Exercise program
description: The runners will be asked to perform the training program twice a week. The intervention consist of muscle control and foam rolling exercises for the lower extremities.
arm group label: Intervention INT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jòn Karlsson, Prof
role: Study Chair
affiliation: Sahlgrenska University Hospital, Sweden
last name: Stefan Grau, Prof
role: Study Director
affiliation: Göteborg University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Pia Desai
investigator title: Doctoral Student
mesh term: Wounds and Injuries
mesh term: Athletic Injuries
sharing ipd: No