<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/NCT03232606</url>
  </required_header>
  <id_info>
    <org_study_id>N°ID-RCB: 2017-A01483-50</org_study_id>
    <nct_id>NCT03232606</nct_id>
  </id_info>
  <brief_title>Physical Activity of Asthmatic Children</brief_title>
  <acronym>Asthmeact</acronym>
  <official_title>Physical Activity of Asthmatic School Children and Teenagers: Evaluation and Perspectives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lorraine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      Physical activity is mandatory to the optimal development and health of children. The&#xD;
      presence of asthmatic manifestations may influence the comportment of children and its family&#xD;
      toward exercise and practice of sports. There no scientific argument to advice a reduction of&#xD;
      physical activity in asthmatic children, but previous studies showed that physical activity&#xD;
      is reduced in asthmatic children.&#xD;
&#xD;
      The aim of this observational study is to evaluate the existing factors leading to this&#xD;
      reduction of physical activity in asthmatic children and their families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical activity is mandatory to the optimal development and health of children. The&#xD;
      presence of asthmatic manifestations may influence the behaviour of children and its family&#xD;
      with a significant reduction of exercise and practice of sports.&#xD;
&#xD;
      There no scientific argument to advice such a reduction of physical activity in asthmatic&#xD;
      children.&#xD;
&#xD;
      The aim of this observational study is to evaluate the existing factors leading to this&#xD;
      reduction of physical activity in asthmatic children and their families.&#xD;
&#xD;
      To evaluate the factors explaining this behaviour the investigator design an observational&#xD;
      study, based on a questionnaire.&#xD;
&#xD;
      The evaluation of the number of sujets to complete this study is 50 asthmatic children. The&#xD;
      whole population will be considered as the same group. This study may be further completed by&#xD;
      a comparative and new study including asthmatic and non-asthmatic children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">November 10, 2017</completion_date>
  <primary_completion_date type="Actual">November 10, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity of children</measure>
    <time_frame>inclusion visit</time_frame>
    <description>Score</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Physical Activity</condition>
  <condition>Asthma</condition>
  <condition>Child Development</condition>
  <arm_group>
    <arm_group_label>Asthmatic children</arm_group_label>
    <description>Asthmatic children aged 6 to 17 year old coming to follow-up at asthma clinic</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Asthmatic cohort of the asthma clinic of the children hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asthmatic children coming for regular follow-up&#xD;
&#xD;
          -  Good control of asthma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous pathologies with significant impact on physical activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cyril E SCHWEITZER, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Lorraine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chru Nancy</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>August 9, 2019</last_update_submitted>
  <last_update_submitted_qc>August 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT03232606
org study id: N°ID-RCB: 2017-A01483-50
nct id: NCT03232606
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physical activity is mandatory to the optimal development and health of children. The
      presence of asthmatic manifestations may influence the comportment of children and its family
      toward exercise and practice of sports. There no scientific argument to advice a reduction of
      physical activity in asthmatic children, but previous studies showed that physical activity
      is reduced in asthmatic children.

      The aim of this observational study is to evaluate the existing factors leading to this
      reduction of physical activity in asthmatic children and their families.
Physical activity is mandatory to the optimal development and health of children. The
      presence of asthmatic manifestations may influence the behaviour of children and its family
      with a significant reduction of exercise and practice of sports.

      There no scientific argument to advice such a reduction of physical activity in asthmatic
      children.

      The aim of this observational study is to evaluate the existing factors leading to this
      reduction of physical activity in asthmatic children and their families.

      To evaluate the factors explaining this behaviour the investigator design an observational
      study, based on a questionnaire.

      The evaluation of the number of sujets to complete this study is 50 asthmatic children. The
      whole population will be considered as the same group. This study may be further completed by
      a comparative and new study including asthmatic and non-asthmatic children.
observational model: Case-Only
time perspective: Prospective
measure: Physical activity of children
time frame: inclusion visit
description: Score
arm group label: Asthmatic children
description: Asthmatic children aged 6 to 17 year old coming to follow-up at asthma clinic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Cyril E SCHWEITZER, MD,PhD
role: Principal Investigator
affiliation: University of Lorraine
facility: 
country: France
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No