<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/NCT04441151</url>
  </required_header>
  <id_info>
    <org_study_id>pulmonary rehabilitation</org_study_id>
    <nct_id>NCT04441151</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy</brief_title>
  <official_title>Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General 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>
      Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen&#xD;
      therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on&#xD;
      patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU&#xD;
      who were treated with high flow humidification apparatus from June 2019 to June 2020 were&#xD;
      randomly divided into two groups. The experimental group was treated with pulmonary&#xD;
      rehabilitation and the control group was treated with routine medical treatment only. All&#xD;
      patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all&#xD;
      patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s&#xD;
      sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and&#xD;
      bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally,&#xD;
      statistics were made on the use of non-invasive ventilator, endotracheal intubation, new&#xD;
      complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting&#xD;
      out of bed for the first time.The end point of the experiment was 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 20, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MRC</measure>
    <time_frame>Day 28</time_frame>
    <description>Medical Research Council,Muscle strength assessment,total points0~60，less than 48scores means ICU aquired weaknesses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>STS</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>barthel index</measure>
    <time_frame>Day 28</time_frame>
    <description>barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100，less than 60 scores means can't independent living.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Borg dyspnea score</measure>
    <time_frame>Day 28</time_frame>
    <description>Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PaO2</measure>
    <time_frame>Day 28</time_frame>
    <description>arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygenation index</measure>
    <time_frame>Day 28</time_frame>
    <description>arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diaphragm mobility</measure>
    <time_frame>Day 28</time_frame>
    <description>The distance the diaphragm drops during inhalation,normal is 1.4cm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diaphragm contraction velocity</measure>
    <time_frame>Day 28</time_frame>
    <description>The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End-inspiratory diaphragm thickness</measure>
    <time_frame>Day 28</time_frame>
    <description>The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End-expiratory diaphragm thickness</measure>
    <time_frame>Day 28</time_frame>
    <description>The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diaphragm thickness variation rate</measure>
    <time_frame>Day 28</time_frame>
    <description>Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU stay time</measure>
    <time_frame>3 month</time_frame>
    <description>icu length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization time</measure>
    <time_frame>Month 3</time_frame>
    <description>Hospitalization time,length of stay in hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time it takes to get out of bed for the first time</measure>
    <time_frame>Day 28</time_frame>
    <description>The time it takes to get out of bed for the first time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of non-invasive ventilator</measure>
    <time_frame>Day 28</time_frame>
    <description>Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation</measure>
    <time_frame>Day 28</time_frame>
    <description>Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>Day 28</time_frame>
    <description>mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication</measure>
    <time_frame>Day 28</time_frame>
    <description>The incidence of new complications(pressure sores、thrombus、aspiration).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pulmonary rehabilitation therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine medical treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pulmonary rehabilitation therapy</intervention_name>
    <description>Comprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The age is ≥ 18 years old;&#xD;
&#xD;
          -  the hemodynamics is stable;&#xD;
&#xD;
          -  50 &lt; heart rate &lt; 120 beats / min ;&#xD;
&#xD;
          -  90 &lt; systolic blood pressure &lt; 200mmHg ;&#xD;
&#xD;
          -  55 &lt; mean arterial pressure &lt; 120mmHg;&#xD;
&#xD;
          -  do not increase the dose of pressor drugs for at least 2 hours;&#xD;
&#xD;
          -  intracranial pressure is stable and there are no seizures within 24 hours;&#xD;
&#xD;
          -  the respiratory state is stable;&#xD;
&#xD;
          -  the patient's finger pulse oxygen saturation ≥ 88%;&#xD;
&#xD;
          -  10 &lt; respiratory frequency &lt; 35 beats / min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  acute cardio-cerebrovascular events;&#xD;
&#xD;
          -  spinal or limb fractures;&#xD;
&#xD;
          -  active bleeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhao Ying</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Medical Center of PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhao Ying</last_name>
    <phone>17600953801</phone>
    <phone_ext>17600953801</phone_ext>
    <email>1412888703@qq.com</email>
  </overall_contact>
  <removed_countries>
    <country>China</country>
  </removed_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>wang kaifei</investigator_full_name>
    <investigator_title>Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</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/NCT04441151
org study id: pulmonary rehabilitation
nct id: NCT04441151
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen
      therapy
Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on
      patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU
      who were treated with high flow humidification apparatus from June 2019 to June 2020 were
      randomly divided into two groups. The experimental group was treated with pulmonary
      rehabilitation and the control group was treated with routine medical treatment only. All
      patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all
      patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s
      sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and
      bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally,
      statistics were made on the use of non-invasive ventilator, endotracheal intubation, new
      complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting
      out of bed for the first time.The end point of the experiment was 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: MRC
time frame: Day 28
description: Medical Research Council,Muscle strength assessment,total points0~60，less than 48scores means ICU aquired weaknesses.
measure: STS
time frame: Day 28
description: Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
measure: barthel index
time frame: Day 28
description: barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100，less than 60 scores means can't independent living.
measure: Borg dyspnea score
time frame: Day 28
description: Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
measure: PaO2
time frame: Day 28
description: arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.
measure: Oxygenation index
time frame: Day 28
description: arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
measure: Diaphragm mobility
time frame: Day 28
description: The distance the diaphragm drops during inhalation,normal is 1.4cm.
measure: Diaphragm contraction velocity
time frame: Day 28
description: The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
measure: End-inspiratory diaphragm thickness
time frame: Day 28
description: The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
measure: End-expiratory diaphragm thickness
time frame: Day 28
description: The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
measure: Diaphragm thickness variation rate
time frame: Day 28
description: Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.
measure: ICU stay time
time frame: 3 month
description: icu length of stay
measure: Hospitalization time
time frame: Month 3
description: Hospitalization time,length of stay in hospital.
measure: The time it takes to get out of bed for the first time
time frame: Day 28
description: The time it takes to get out of bed for the first time
measure: Use of non-invasive ventilator
time frame: Day 28
description: Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.
measure: Intubation
time frame: Day 28
description: Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days
measure: mortality
time frame: Day 28
description: mortality
measure: Complication
time frame: Day 28
description: The incidence of new complications(pressure sores、thrombus、aspiration).
arm group label: Experimental group
arm group type: Experimental
description: Pulmonary rehabilitation therapy
arm group label: Control group
arm group type: No Intervention
description: Routine medical treatment
intervention type: Behavioral
intervention name: Pulmonary rehabilitation therapy
description: Comprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Zhao Ying
role: Principal Investigator
affiliation: The First Medical Center of PLA General Hospital
last name: Zhao Ying
phone: 17600953801
phone ext: 17600953801
email: 1412888703@qq.com
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: wang kaifei
investigator title: Ph.D.
mesh term: Lung Diseases
sharing ipd: No