<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/NCT04463732</url>
  </required_header>
  <id_info>
    <org_study_id>202005050RINA</org_study_id>
    <nct_id>NCT04463732</nct_id>
  </id_info>
  <brief_title>The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults</brief_title>
  <official_title>The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maximal oxygen consumption, VO2max, is the gold standard to evaluate human aerobic fitness,&#xD;
      which stands for the maximal capacity of cardiorespiratory system and musculoskeletal system&#xD;
      to transport and utilize oxygen. Previous study showed that there is significant correlation&#xD;
      between maximal oxygen consumption from cardiopulmonary exercise test and strength and&#xD;
      endurance of lower extremities. In people with sedentary lifestyle, they often limited by the&#xD;
      lower limb muscle performance during cardiopulmonary exercise test. Their breathing patterns&#xD;
      are more irregular than athletes during cardiopulmonary exercise test. However, there is no&#xD;
      study comparing the activation pattern of respiratory muscles between these two groups.&#xD;
      Whether the breathing pattern in people with lower exercise capacity is less efficient under&#xD;
      exertional activities still unknown. The purpose of this study is to investigate the&#xD;
      relationship between maximal oxygen consumption and inspiratory muscle activation pattern in&#xD;
      healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diaphragm and Sternocleidomastoid muscle activation</measure>
    <time_frame>during the loaded inspiratory muscle test condition; it would take about 3 minutes</time_frame>
    <description>Root mean square values</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal exercise capacity</measure>
    <time_frame>during the cardiopulmonary exercise test; it would take about 12 to 15 minutes</time_frame>
    <description>Maximal oxygen consumption</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy group</arm_group_label>
    <description>Subjects are above 20 years old. Their condition is healthy with no history of inspiratory disease. They can cooperate with the measurements of this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Loaded inspiratory muscle test and cardiopulmonary exercise test</intervention_name>
    <description>This is an observational study. Loaded inspiratory muscle test is setting at 30% of maximal inspiratory pressure. Subjects will perform only 15 breaths under this intensity to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training. Cardiopulmonary exercise test is performed by using bicycle ergometer. These two tests will be performed at least 1 week separately.</description>
    <arm_group_label>Healthy group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy population is free from abnormal breathing pattern caused by disease. Their&#xD;
        terminals of cardiopulmonary exercise test are not limited by symptoms of disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults (age &gt; 20 years old)&#xD;
&#xD;
          -  Be able to cooperate with the measurements of this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any clinical diagnosis that will influence the measurement, including any history of&#xD;
             neuromyopathy&#xD;
&#xD;
          -  angina, acute myocardial infarction in the previous one month&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  history of syncope during exercise&#xD;
&#xD;
          -  any musculoskeletal system disorder that unable to perform cardiopulmonary exercise&#xD;
             test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li-Ying Wang, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School and Graduate Institute of Physical Therapy of National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <state>Zhongzheng Dist</state>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</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>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <!-- 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/NCT04463732
org study id: 202005050RINA
nct id: NCT04463732
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Maximal oxygen consumption, VO2max, is the gold standard to evaluate human aerobic fitness,
      which stands for the maximal capacity of cardiorespiratory system and musculoskeletal system
      to transport and utilize oxygen. Previous study showed that there is significant correlation
      between maximal oxygen consumption from cardiopulmonary exercise test and strength and
      endurance of lower extremities. In people with sedentary lifestyle, they often limited by the
      lower limb muscle performance during cardiopulmonary exercise test. Their breathing patterns
      are more irregular than athletes during cardiopulmonary exercise test. However, there is no
      study comparing the activation pattern of respiratory muscles between these two groups.
      Whether the breathing pattern in people with lower exercise capacity is less efficient under
      exertional activities still unknown. The purpose of this study is to investigate the
      relationship between maximal oxygen consumption and inspiratory muscle activation pattern in
      healthy adults.
observational model: Cohort
time perspective: Cross-Sectional
measure: Diaphragm and Sternocleidomastoid muscle activation
time frame: during the loaded inspiratory muscle test condition; it would take about 3 minutes
description: Root mean square values
measure: Maximal exercise capacity
time frame: during the cardiopulmonary exercise test; it would take about 12 to 15 minutes
description: Maximal oxygen consumption
arm group label: Healthy group
description: Subjects are above 20 years old. Their condition is healthy with no history of inspiratory disease. They can cooperate with the measurements of this study.
intervention type: Other
intervention name: Loaded inspiratory muscle test and cardiopulmonary exercise test
description: This is an observational study. Loaded inspiratory muscle test is setting at 30% of maximal inspiratory pressure. Subjects will perform only 15 breaths under this intensity to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training. Cardiopulmonary exercise test is performed by using bicycle ergometer. These two tests will be performed at least 1 week separately.
arm group label: Healthy group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Li-Ying Wang, PhD
role: Study Chair
affiliation: National Taiwan University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Respiratory Aspiration