<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/NCT04481295</url>
  </required_header>
  <id_info>
    <org_study_id>2019-24</org_study_id>
    <nct_id>NCT04481295</nct_id>
  </id_info>
  <brief_title>Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation</brief_title>
  <official_title>Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Hospital Organization Minami Kyoto Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Hospital Organization Minami Kyoto 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>
      The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2&#xD;
      94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during&#xD;
      pulmonary rehabilitation for the patients with chronic respiratory failure receiving&#xD;
      long-term oxygen therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an&#xD;
      evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and&#xD;
      quality of life. However, optimal SpO2 value during pulmonary rehabilitation in patients with&#xD;
      chronic respiratory failure receiving long-term oxygen therapy is unclear.&#xD;
&#xD;
      The present study is randomized to compare the effect of exercise capacity between high SpO2&#xD;
      (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2&#xD;
      84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory&#xD;
      failure receiving long-term oxygen therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 18, 2020</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation</measure>
    <time_frame>four weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>High-flow Nasal Cannula</condition>
  <condition>Exercise Capacity</condition>
  <condition>Chronic Respiratory Failure</condition>
  <condition>Optimal SpO2 Value</condition>
  <arm_group>
    <arm_group_label>High SpO2 group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low SpO2 group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-flow nasal cannula</intervention_name>
    <description>The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.</description>
    <arm_group_label>High SpO2 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low SpO2</intervention_name>
    <description>Low SpO2</description>
    <arm_group_label>Low SpO2 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with chronic respiratory failure receiving long-term oxygen therapy for more&#xD;
             than 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with severe cardiovascular disease, liver disease, neurological disease, and&#xD;
             renal failure.&#xD;
&#xD;
          -  Subjects with a history of hospitalization for pneumonia or exacerbation of&#xD;
             respiratory failure within the last month.&#xD;
&#xD;
          -  Subjects with changes in LTOT prescription flow within the last month&#xD;
&#xD;
          -  Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure,&#xD;
             arteriosclerosis obliterans or spinal disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuichi Chihara</last_name>
    <phone>81-774-52-0065</phone>
    <email>yc.r03107@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Hospital Organization Minami Kyoto Hospital</name>
      <address>
        <city>Joyo</city>
        <state>Kyoto</state>
        <zip>610-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuichi Chihara, MD., PhD.</last_name>
      <phone>81-774-52-0065</phone>
      <email>yc.r03107@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>March 25, 2023</last_update_submitted>
  <last_update_submitted_qc>March 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HFNC</keyword>
  <keyword>6MWD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT04481295
org study id: 2019-24
nct id: NCT04481295
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2
      94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during
      pulmonary rehabilitation for the patients with chronic respiratory failure receiving
      long-term oxygen therapy.
In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an
      evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and
      quality of life. However, optimal SpO2 value during pulmonary rehabilitation in patients with
      chronic respiratory failure receiving long-term oxygen therapy is unclear.

      The present study is randomized to compare the effect of exercise capacity between high SpO2
      (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2
      84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory
      failure receiving long-term oxygen therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
measure: Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation
time frame: four weeks
arm group label: High SpO2 group
arm group type: Active Comparator
description: In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min).
arm group label: Low SpO2 group
arm group type: Active Comparator
description: In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min).
intervention type: Other
intervention name: High-flow nasal cannula
description: The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
arm group label: High SpO2 group
intervention type: Other
intervention name: Low SpO2
description: Low SpO2
arm group label: Low SpO2 group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yuichi Chihara
phone: 81-774-52-0065
email: yc.r03107@gmail.com
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
sharing ipd: Undecided