<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/NCT03276299</url>
  </required_header>
  <id_info>
    <org_study_id>Child6MWT</org_study_id>
    <nct_id>NCT03276299</nct_id>
  </id_info>
  <brief_title>Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years</brief_title>
  <official_title>Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</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>
      Evaluation of the learning and encouragement effect on six minutes walking test in children&#xD;
      under 12 years&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>distance</measure>
    <time_frame>six minutes</time_frame>
    <description>walked distance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>six minutes</time_frame>
    <description>heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulsed oxygen saturation</measure>
    <time_frame>six minutes</time_frame>
    <description>pulsed oxygen saturation</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Healthy Children</condition>
  <arm_group>
    <arm_group_label>test 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>six minute walking test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>six minute walking test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test with encouragement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>six minute walking test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test without encouragement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>six minute walking test</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>six minute walking test</intervention_name>
    <description>six minute walking test</description>
    <arm_group_label>test 1</arm_group_label>
    <arm_group_label>test 2</arm_group_label>
    <arm_group_label>test without encouragement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>six minute walking test</intervention_name>
    <description>six minute walking test with encouragement</description>
    <arm_group_label>test with encouragement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute or chronic lung, cardiac or neuromuscular disease&#xD;
&#xD;
          -  at risk of- or overweight (BMI higher than 85th percentile for children of the same&#xD;
             age and sex)&#xD;
&#xD;
          -  a motor disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique universitaire Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03276299
org study id: Child6MWT
nct id: NCT03276299
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of the learning and encouragement effect on six minutes walking test in children
      under 12 years
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: distance
time frame: six minutes
description: walked distance
measure: heart rate
time frame: six minutes
description: heart rate
measure: pulsed oxygen saturation
time frame: six minutes
description: pulsed oxygen saturation
arm group label: test 1
arm group type: Active Comparator
description: six minute walking test
arm group label: test 2
arm group type: Experimental
description: six minute walking test
arm group label: test with encouragement
arm group type: Experimental
description: six minute walking test
arm group label: test without encouragement
arm group type: Active Comparator
description: six minute walking test
intervention type: Other
intervention name: six minute walking test
description: six minute walking test
arm group label: test 1
arm group label: test 2
arm group label: test without encouragement
intervention type: Other
intervention name: six minute walking test
description: six minute walking test with encouragement
arm group label: test with encouragement
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No