<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/NCT04406220</url>
  </required_header>
  <id_info>
    <org_study_id>2019-clog</org_study_id>
    <nct_id>NCT04406220</nct_id>
  </id_info>
  <brief_title>The Effect of Large Versus Small Clog Size on Emergency Response Time</brief_title>
  <official_title>The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</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>
      In many hospitals, clogs, usually white, are provided for healthcare workers. In our&#xD;
      hospital, health care professionals from the department of intensive care medicine may be&#xD;
      summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for&#xD;
      running. Although clogs are available in several sizes, clog size is typically left to the&#xD;
      discretion of the individual healthcare worker. Interestingly,&#xD;
&#xD;
      The primary goal of this randomized controlled trial is to assess if wearing large size clogs&#xD;
      as compared to small size clogs results in increased running speed.&#xD;
&#xD;
      Participants will be randomized to small versus large clog size using a using randomly&#xD;
      permuted blocks stratified by gender. Following randomization, participants will wear the&#xD;
      clogs of allocated size and complete a standardized running course.&#xD;
&#xD;
      The primary endpoint is the time taken to complete the course.&#xD;
&#xD;
      The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the&#xD;
      response time at an average response time of 30 seconds with a 6 second standard deviation.&#xD;
&#xD;
      The ethical committee judged the study protocol exempt from extensive review.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2020</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to complete the running course</measure>
    <time_frame>Follow-up until 60 minutes.</time_frame>
    <description>The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Follow-up until 60 minutes.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to complete the running course for specific subgroups: By gender, job function, level of fitness.</measure>
    <time_frame>Follow-up until 60 minutes.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Clothing</condition>
  <condition>Occupational Injuries</condition>
  <arm_group>
    <arm_group_label>Small clog size</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Large clog size</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Small clog size</intervention_name>
    <description>Participants will be randomized to run in small clogs</description>
    <arm_group_label>Small clog size</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Large clog size</intervention_name>
    <description>Participants will be randomized to run in large clogs</description>
    <arm_group_label>Large clog size</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthcare workers aged 18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to run on clogs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Elbers, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Amsterdam UMC, location VUmc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amsterdam UMC, location VUmc</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>March 2, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>H.J.S. de Grooth, MD</investigator_full_name>
    <investigator_title>Coordinating investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Occupational Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04406220
org study id: 2019-clog
nct id: NCT04406220
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In many hospitals, clogs, usually white, are provided for healthcare workers. In our
      hospital, health care professionals from the department of intensive care medicine may be
      summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for
      running. Although clogs are available in several sizes, clog size is typically left to the
      discretion of the individual healthcare worker. Interestingly,

      The primary goal of this randomized controlled trial is to assess if wearing large size clogs
      as compared to small size clogs results in increased running speed.

      Participants will be randomized to small versus large clog size using a using randomly
      permuted blocks stratified by gender. Following randomization, participants will wear the
      clogs of allocated size and complete a standardized running course.

      The primary endpoint is the time taken to complete the course.

      The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the
      response time at an average response time of 30 seconds with a 6 second standard deviation.

      The ethical committee judged the study protocol exempt from extensive review.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Time to complete the running course
time frame: Follow-up until 60 minutes.
description: The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates.
measure: Adverse events
time frame: Follow-up until 60 minutes.
measure: Time to complete the running course for specific subgroups: By gender, job function, level of fitness.
time frame: Follow-up until 60 minutes.
arm group label: Small clog size
arm group type: Active Comparator
arm group label: Large clog size
arm group type: Active Comparator
intervention type: Other
intervention name: Small clog size
description: Participants will be randomized to run in small clogs
arm group label: Small clog size
intervention type: Other
intervention name: Large clog size
description: Participants will be randomized to run in large clogs
arm group label: Large clog size
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Elbers, MD, PhD
role: Study Chair
affiliation: Amsterdam UMC, location VUmc
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: H.J.S. de Grooth, MD
investigator title: Coordinating investigator
mesh term: Emergencies
mesh term: Occupational Injuries
sharing ipd: Undecided