xml: <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/NCT05963919</url>
    </required_header>
    <id_info>
      <org_study_id>Atlasumkaya01</org_study_id>
      <nct_id>NCT05963919</nct_id>
    </id_info>
    <brief_title>Determinants of Functional Capacity in Children With Asthma</brief_title>
    <official_title>Determinants of Functional Capacity in Children With Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Atlas University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Atlas University</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 primary aim of this study is to compare the respiratory function, respiratory muscle&#xD;
        strength, functional capacity, and lower extremity strength of children with asthma and&#xD;
        healthy children in the same age group. The secondary aim of our study is to determine the&#xD;
        determinants of functional capacity in children with asthma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>6-minute walk test</measure>
      <time_frame>15-20 minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Forced expiratory volume in 1 second (FEV1)</measure>
      <time_frame>10-15 minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak expiratory flow (PEF)</measure>
      <time_frame>10-15 minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximal inspiratory pressure (MIP)</measure>
      <time_frame>15-20 minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximal expiratory pressure (MEP)</measure>
      <time_frame>15-20 minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower extremity muscle strength</measure>
      <time_frame>5-10 minutes</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Asthma in Children</condition>
    <arm_group>
      <arm_group_label>Asthma Group</arm_group_label>
      <description>6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <description>6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>6-minute walk test</intervention_name>
      <description>Functional capacity will be assessed with the 6-minute walk test (6MWT). 6MWT will be performed in accordance with the criteria of the American Thoracic Society. The 6MWT distance will be recorded in meters.</description>
      <arm_group_label>Asthma Group</arm_group_label>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pulmonary function test</intervention_name>
      <description>Pulmonary function test will be performed with a spirometer (&quot;COSMED Pony FX&quot; (COSMED; Italy) by ATS/ERS criteria. Forced expiratory volume in 1 second (FEV1) and peak expiratory volume (PEF) parameters will be measured. The results will be recorded both as a percentage of measured values and expected values.</description>
      <arm_group_label>Asthma Group</arm_group_label>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Respiratory muscle strength test</intervention_name>
      <description>Respiratory muscle strength will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values will be recorded. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.</description>
      <arm_group_label>Asthma Group</arm_group_label>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Lower extremity muscle strength test</intervention_name>
      <description>The 30-Second Chair Test is administered using a folding chair without arms, with a seat height of 17 inches (43.2 cm). The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving. The participant is seated in the middle of the chair, back straight; feet approximately a shoulder width apart, and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.</description>
      <arm_group_label>Asthma Group</arm_group_label>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children with asthma aged between 6-17 years and healthy children aged between 6-17 years&#xD;
          will be included in the study. Informed consent forms for the study prepared for both the&#xD;
          asthma group and the control group will be carefully explained and the participants will be&#xD;
          included in the study after they and their parents have read, understood, and accepted.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Asthma Group Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 6-17&#xD;
  &#xD;
            -  Being diagnosed with asthma&#xD;
  &#xD;
            -  Able to walk, cooperate and clinically stable&#xD;
  &#xD;
            -  Being a volunteer to participate in the study&#xD;
  &#xD;
            -  To be able to speak, read, understand, and cooperate in Turkish&#xD;
  &#xD;
          Asthma Group Exclusion Criteria:&#xD;
  &#xD;
            -  History of previous lung or liver transplant&#xD;
  &#xD;
            -  Having an acute exacerbation and/or a history of hospitalization in the last 1 month&#xD;
  &#xD;
            -  Having diagnosed orthopedic problems affecting mobility or a history of&#xD;
               musculoskeletal surgery&#xD;
  &#xD;
          Control Group Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 6-17&#xD;
  &#xD;
            -  To be able to speak, read, understand, and cooperate in Turkish&#xD;
  &#xD;
            -  Being a volunteer to participate in the study&#xD;
  &#xD;
          Control Group Exclusion Criteria:&#xD;
  &#xD;
            -  Having a diagnosed vision, hearing, or neurological disease that may affect balance&#xD;
  &#xD;
            -  Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic&#xD;
               disease or pathological condition that would affect assessments&#xD;
  &#xD;
            -  Resting saturation below 90% during exercise tests&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Istanbul Atlas University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</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>
  
  
text: 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/NCT05963919
  org study id: Atlasumkaya01
  nct id: NCT05963919
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary aim of this study is to compare the respiratory function, respiratory muscle
        strength, functional capacity, and lower extremity strength of children with asthma and
        healthy children in the same age group. The secondary aim of our study is to determine the
        determinants of functional capacity in children with asthma.
  observational model: Case-Control
  time perspective: Prospective
  measure: 6-minute walk test
  time frame: 15-20 minutes
  measure: Forced expiratory volume in 1 second (FEV1)
  time frame: 10-15 minutes
  measure: Peak expiratory flow (PEF)
  time frame: 10-15 minutes
  measure: Maximal inspiratory pressure (MIP)
  time frame: 15-20 minutes
  measure: Maximal expiratory pressure (MEP)
  time frame: 15-20 minutes
  measure: Lower extremity muscle strength
  time frame: 5-10 minutes
  arm group label: Asthma Group
  description: 6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test
  arm group label: Control Group
  description: 6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test
  intervention type: Other
  intervention name: 6-minute walk test
  description: Functional capacity will be assessed with the 6-minute walk test (6MWT). 6MWT will be performed in accordance with the criteria of the American Thoracic Society. The 6MWT distance will be recorded in meters.
  arm group label: Asthma Group
  arm group label: Control Group
  intervention type: Other
  intervention name: Pulmonary function test
  description: Pulmonary function test will be performed with a spirometer ("COSMED Pony FX" (COSMED; Italy) by ATS/ERS criteria. Forced expiratory volume in 1 second (FEV1) and peak expiratory volume (PEF) parameters will be measured. The results will be recorded both as a percentage of measured values and expected values.
  arm group label: Asthma Group
  arm group label: Control Group
  intervention type: Other
  intervention name: Respiratory muscle strength test
  description: Respiratory muscle strength will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values will be recorded. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
  arm group label: Asthma Group
  arm group label: Control Group
  intervention type: Other
  intervention name: Lower extremity muscle strength test
  description: The 30-Second Chair Test is administered using a folding chair without arms, with a seat height of 17 inches (43.2 cm). The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving. The participant is seated in the middle of the chair, back straight; feet approximately a shoulder width apart, and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.
  arm group label: Asthma Group
  arm group label: Control Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: No