<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/NCT04444362</url>
  </required_header>
  <id_info>
    <org_study_id>IMT-Jph 2020</org_study_id>
    <nct_id>NCT04444362</nct_id>
  </id_info>
  <brief_title>Effects of IMT on Clinical Outcomes in Cardiac Surgery</brief_title>
  <official_title>Effects of Inspiratory Muscle Training on Clinical Outcomes in Individuals With Cardiac Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Individuals who underwent cardiac surgery may experience anesthesia, intracardiac operation,&#xD;
      cardiopulmonary bypass and mechanical ventilation, which will result in a lot of injuries.&#xD;
      Inspiratory Muscle Training (IMT) is a regimen of breathing exercises that aim to strengthen&#xD;
      the respiratory muscles and make it easier for a person to breathe. The aim of this study was&#xD;
      to evaluate the efficacy of preoperative IMT on e clinical outcomes in patients with cardiac&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Due to the nature of this research, we could not keep the participants blind to group assignment, but the study staff and statistical analyses were all blind to patient allocation during datacollection</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative intubation time</measure>
    <time_frame>5 days after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative length of stay</measure>
    <time_frame>30 days after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Inspiratory Muscle Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Inspiratory Muscle Training group received respiratory muscle training, in addition to routine preparation, including laboratory and radiological examinations and preoperative education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group received routine preparation, including laboratory and radiological examinations and preoperative education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inspiratory Muscle Training</intervention_name>
    <description>IMT underwent 5 days of 30 breaths twice daily at 50% (+5% increase each week) of maximum inspiratory pressure (MIP)</description>
    <arm_group_label>Inspiratory Muscle Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult men and women&#xD;
&#xD;
          -  Elective cardiac surgery&#xD;
&#xD;
          -  Cardiac surgery on cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with neurological diseases that may make it impossible to perform IMT&#xD;
&#xD;
          -  Emergency cardiac surgery&#xD;
&#xD;
          -  Cardiac surgery without cardiopulmonary bypass&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hong Liu</last_name>
    <phone>18801281613</phone>
    <email>DR.HONGLIU@FOXMAIL.COM</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yong-feng Shao</last_name>
    <email>yfshaojph@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of nanjing medical university</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Liu, MD</last_name>
      <phone>188012181613</phone>
      <email>dr.hongliu@foxmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>April 15, 2022</last_update_submitted>
  <last_update_submitted_qc>April 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Hong Liu</investigator_full_name>
    <investigator_title>Investigator of Cardio-Thoracic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular 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/NCT04444362
org study id: IMT-Jph 2020
nct id: NCT04444362
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Individuals who underwent cardiac surgery may experience anesthesia, intracardiac operation,
      cardiopulmonary bypass and mechanical ventilation, which will result in a lot of injuries.
      Inspiratory Muscle Training (IMT) is a regimen of breathing exercises that aim to strengthen
      the respiratory muscles and make it easier for a person to breathe. The aim of this study was
      to evaluate the efficacy of preoperative IMT on e clinical outcomes in patients with cardiac
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
masking description: Due to the nature of this research, we could not keep the participants blind to group assignment, but the study staff and statistical analyses were all blind to patient allocation during datacollection
measure: Postoperative intubation time
time frame: 5 days after surgery
measure: Postoperative length of stay
time frame: 30 days after surgery
arm group label: Inspiratory Muscle Training
arm group type: Experimental
description: The Inspiratory Muscle Training group received respiratory muscle training, in addition to routine preparation, including laboratory and radiological examinations and preoperative education.
arm group label: Control
arm group type: No Intervention
description: The control group received routine preparation, including laboratory and radiological examinations and preoperative education.
intervention type: Device
intervention name: Inspiratory Muscle Training
description: IMT underwent 5 days of 30 breaths twice daily at 50% (+5% increase each week) of maximum inspiratory pressure (MIP)
arm group label: Inspiratory Muscle Training
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hong Liu
phone: 18801281613
email: DR.HONGLIU@FOXMAIL.COM
last name: Yong-feng Shao
email: yfshaojph@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Hong Liu
investigator title: Investigator of Cardio-Thoracic Surgery
mesh term: Cardiovascular Diseases
sharing ipd: No