<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/NCT03237962</url>
  </required_header>
  <id_info>
    <org_study_id>NMRPD1F0731</org_study_id>
    <nct_id>NCT03237962</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannula During Pulmonary Rehabilitation</brief_title>
  <official_title>Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung 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 purpose of this study is to compare and assess the immediate and long-term&#xD;
      effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen&#xD;
      therapy device.&#xD;
&#xD;
      The hypotheses was, with high flow nasal cannula usage while exercising, the physiological&#xD;
      outcome measurements would be better than conventional oxygen therapy device. Also, the usage&#xD;
      of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused&#xD;
      by exercising.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary Rehabilitation is one of the most recommended methods to improve the muscle&#xD;
      function of COPD patients. By exercise training, even patients with severe COPD can increase&#xD;
      muscle strength, improve skeletal muscle function and enhance exercise endurance. Due to&#xD;
      improvements in exercise endurance, when exercising at a higher intensity, ventilation&#xD;
      support and dynamic hyperinflation would slightly decrease which leads to less dyspnea during&#xD;
      exercise. Continuously exercising can also increase the motivation to exercise, reduce mood&#xD;
      irritability and psychological burden caused by symptoms. By exercising, patient's health&#xD;
      status can be both improved physically and mentally.&#xD;
&#xD;
      High Flow Nasal Cannula (HFNC) is a non-invasive ventilatory device that provides stable&#xD;
      oxygen concentration, temperature (37℃) and humidity (Relative Humidity: 100%). Humidity&#xD;
      provided by the HFNC reduces irritation caused by the high flow, which leads to the increase&#xD;
      of user's tolerance with the device. With the half-closed system formed by a nasal prong,&#xD;
      when the high flow enters the upper airway, continue positive airway pressure would be&#xD;
      formed.&#xD;
&#xD;
      Subjects enrolled into this study are required to join a 6-week pulmonary rehabilitation&#xD;
      program. Before starting the program, subjects were randomly assigned to high flow nasal&#xD;
      cannula group and conventional oxygen therapy group. When exercising, the nasal cannula group&#xD;
      would receive an oxygen flow of 3 - 5L to maintain SpO2&gt;90% and the HFNC group with high flow&#xD;
      setting of 45-50Lpm along with oxygen flow of 3-5L also to maintain SpO2&gt;90%. When joining&#xD;
      the pulmonary rehabilitation program, patients are required to exercise for approximately 45&#xD;
      minutes per session. When exercising, changes in the degree of dyspnea, quadriceps blood flow&#xD;
      and hemodynamics are assessed. After 6-week of the exercise training, all the parameters will&#xD;
      again be assessed and compared to the primary data that was collected from the beginning of&#xD;
      the program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Output in L/min</measure>
    <time_frame>Changes from baseline to 6 weeks and 12 weeks</time_frame>
    <description>Heart rate and stroke volume will be combined to report cardiac output in L/min</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COPD Assessment Test (CAT)</measure>
    <time_frame>Changes from baseline to 6 weeks and 12 weeks</time_frame>
    <description>Questionnaire designed to evaluate COPD patient's quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Medical Research Council (mMRC) Dyspnea Scale</measure>
    <time_frame>Changes from baseline to 6 weeks and 12 weeks</time_frame>
    <description>Scale to determine the breathlessness of COPD patients during their daily activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum inspiratory pressure in cmH2O</measure>
    <time_frame>Changes from baseline to 6 weeks and 12 weeks</time_frame>
    <description>The maximum inspiratory pressure in cmH2O represents the strength of the abdominal and expiratory muscles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum expiratory pressure in cmH2O</measure>
    <time_frame>Changes from baseline to 6 weeks and 12 weeks</time_frame>
    <description>The maximum expiratory pressure in cmH2O</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Saturation Index</measure>
    <time_frame>Changes from baseline to 6 weeks and 12 weeks</time_frame>
    <description>Tissue Saturation Index measured by near-Infrared spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Hemoglobin</measure>
    <time_frame>Changes from baseline to 6 weeks and 12 weeks</time_frame>
    <description>Total Hemoglobin measured by near-Infrared spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg Scale</measure>
    <time_frame>Changes from baseline to 6 weeks and 12 weeks</time_frame>
    <description>Scale examining the level of dyspnea or the shortness of breath during exercise</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>High Flow Nasal Cannula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are randomly assigned into High flow nasal cannula group for the exercise training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal Cannula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are randomly assigned into nasal cannula group for the exercise training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High Flow Nasal Cannula</intervention_name>
    <description>High Flow Nasal Cannula (HFNC) is an oxygen device that increases oxygenation and washes out CO2 within the dead space, it was also clinically used to correct hypoxemia, hypercapnia and respiratory failure.By providing flow rate that is similar to or higher than the patient's inspiratory flow, HFNC is able to provide ventilatory support. To produce stable oxygen concentration, HFNC entrains less air in order to reach the preset value.</description>
    <arm_group_label>High Flow Nasal Cannula</arm_group_label>
    <other_name>HFNC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal Cannula</intervention_name>
    <description>Nasal cannula is an oxygen therapy device that has been commonly used as treatment for patients with hypoxemia. With the adjustable flow of 1-6Lpm, the concentration of the oxygen differs as the breathing pattern of the patient changes.</description>
    <arm_group_label>Nasal Cannula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 55 years&#xD;
&#xD;
          -  COPD patients with confirmed pulmonary function test results of FEV1&lt;70%&#xD;
&#xD;
          -  Regular follow-up at the pulmonary medicine clinic&#xD;
&#xD;
          -  Stable condition without acute exacerbation&#xD;
&#xD;
          -  No pulmonary rehabilitation training within a year&#xD;
&#xD;
          -  None oxygen usage at home&#xD;
&#xD;
          -  No smoking history or quit smoking&#xD;
&#xD;
          -  Inform consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fever (Body Temperature &gt;37.5°C)&#xD;
&#xD;
          -  Acute infection symptoms&#xD;
&#xD;
          -  Unstable cardiovascular status (Eg: Blood pressure &gt;150/100 mmHg after medication&#xD;
             usage, angina pectoris, or abnormal ECG)&#xD;
&#xD;
          -  Activity restrictions due to orthopedic or neuromuscular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui-Ling Lin, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Linkou Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>61363</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 16, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>February 22, 2019</last_update_submitted>
  <last_update_submitted_qc>February 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung University</investigator_affiliation>
    <investigator_full_name>Hui-Ling Lin</investigator_full_name>
    <investigator_title>Assistant Proffesor</investigator_title>
  </responsible_party>
  <keyword>High flow nasal cannula</keyword>
  <keyword>Pulmonary rehab</keyword>
  <keyword>Pulmonary rehabilitation</keyword>
  <keyword>Nasal cannula</keyword>
  <keyword>Exercise endurance</keyword>
  <keyword>Oxygen Therapy</keyword>
  <keyword>COPD</keyword>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 29, 2020</submitted>
    <returned>February 7, 2020</returned>
  </pending_results>
  <!-- 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/NCT03237962
org study id: NMRPD1F0731
nct id: NCT03237962
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to compare and assess the immediate and long-term
      effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen
      therapy device.

      The hypotheses was, with high flow nasal cannula usage while exercising, the physiological
      outcome measurements would be better than conventional oxygen therapy device. Also, the usage
      of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused
      by exercising.
Pulmonary Rehabilitation is one of the most recommended methods to improve the muscle
      function of COPD patients. By exercise training, even patients with severe COPD can increase
      muscle strength, improve skeletal muscle function and enhance exercise endurance. Due to
      improvements in exercise endurance, when exercising at a higher intensity, ventilation
      support and dynamic hyperinflation would slightly decrease which leads to less dyspnea during
      exercise. Continuously exercising can also increase the motivation to exercise, reduce mood
      irritability and psychological burden caused by symptoms. By exercising, patient's health
      status can be both improved physically and mentally.

      High Flow Nasal Cannula (HFNC) is a non-invasive ventilatory device that provides stable
      oxygen concentration, temperature (37℃) and humidity (Relative Humidity: 100%). Humidity
      provided by the HFNC reduces irritation caused by the high flow, which leads to the increase
      of user's tolerance with the device. With the half-closed system formed by a nasal prong,
      when the high flow enters the upper airway, continue positive airway pressure would be
      formed.

      Subjects enrolled into this study are required to join a 6-week pulmonary rehabilitation
      program. Before starting the program, subjects were randomly assigned to high flow nasal
      cannula group and conventional oxygen therapy group. When exercising, the nasal cannula group
      would receive an oxygen flow of 3 - 5L to maintain SpO2>90% and the HFNC group with high flow
      setting of 45-50Lpm along with oxygen flow of 3-5L also to maintain SpO2>90%. When joining
      the pulmonary rehabilitation program, patients are required to exercise for approximately 45
      minutes per session. When exercising, changes in the degree of dyspnea, quadriceps blood flow
      and hemodynamics are assessed. After 6-week of the exercise training, all the parameters will
      again be assessed and compared to the primary data that was collected from the beginning of
      the program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Cardiac Output in L/min
time frame: Changes from baseline to 6 weeks and 12 weeks
description: Heart rate and stroke volume will be combined to report cardiac output in L/min
measure: COPD Assessment Test (CAT)
time frame: Changes from baseline to 6 weeks and 12 weeks
description: Questionnaire designed to evaluate COPD patient's quality of life.
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
time frame: Changes from baseline to 6 weeks and 12 weeks
description: Scale to determine the breathlessness of COPD patients during their daily activity
measure: The maximum inspiratory pressure in cmH2O
time frame: Changes from baseline to 6 weeks and 12 weeks
description: The maximum inspiratory pressure in cmH2O represents the strength of the abdominal and expiratory muscles
measure: The maximum expiratory pressure in cmH2O
time frame: Changes from baseline to 6 weeks and 12 weeks
description: The maximum expiratory pressure in cmH2O
measure: Tissue Saturation Index
time frame: Changes from baseline to 6 weeks and 12 weeks
description: Tissue Saturation Index measured by near-Infrared spectroscopy
measure: Total Hemoglobin
time frame: Changes from baseline to 6 weeks and 12 weeks
description: Total Hemoglobin measured by near-Infrared spectroscopy
measure: Borg Scale
time frame: Changes from baseline to 6 weeks and 12 weeks
description: Scale examining the level of dyspnea or the shortness of breath during exercise
arm group label: High Flow Nasal Cannula
arm group type: Experimental
description: Patients are randomly assigned into High flow nasal cannula group for the exercise training
arm group label: Nasal Cannula
arm group type: Experimental
description: Patients are randomly assigned into nasal cannula group for the exercise training.
intervention type: Device
intervention name: High Flow Nasal Cannula
description: High Flow Nasal Cannula (HFNC) is an oxygen device that increases oxygenation and washes out CO2 within the dead space, it was also clinically used to correct hypoxemia, hypercapnia and respiratory failure.By providing flow rate that is similar to or higher than the patient's inspiratory flow, HFNC is able to provide ventilatory support. To produce stable oxygen concentration, HFNC entrains less air in order to reach the preset value.
arm group label: High Flow Nasal Cannula
other name: HFNC
intervention type: Device
intervention name: Nasal Cannula
description: Nasal cannula is an oxygen therapy device that has been commonly used as treatment for patients with hypoxemia. With the adjustable flow of 1-6Lpm, the concentration of the oxygen differs as the breathing pattern of the patient changes.
arm group label: Nasal Cannula
criteria: 
gender: All
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hui-Ling Lin, MSc
role: Principal Investigator
affiliation: Chang Gung University
facility: 
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung University
investigator full name: Hui-Ling Lin
investigator title: Assistant Proffesor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
submitted: January 29, 2020
returned: February 7, 2020