<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/NCT04491760</url>
  </required_header>
  <id_info>
    <org_study_id>No.GDREC2019521H(R1)</org_study_id>
    <nct_id>NCT04491760</nct_id>
  </id_info>
  <brief_title>Inspiratory Muscle Training in Patients With Acute Myocardial Infarction</brief_title>
  <official_title>Feasibility of Inspiratory Muscle Training in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention and Complicated With High Risk of Pneumonia: a Randomized Controlled Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial People's Hospital</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>
      Pneumonia is uncommon high among patients with acute myocardial infarction (AMI), which&#xD;
      increases adverse clinical events and prolongs the hospital stay. Inspiratory muscle training&#xD;
      (IMT) is able to improve inspiratory muscle strength and prevent pneumonia in patients&#xD;
      undergoing cardiac surgery including coronary artery bypass grafting. Thus, the investigators&#xD;
      design the study mainly aim to evaluate the 30 days IMT for the change of inspiratory muscle&#xD;
      strength, and also to observe its potentially effect on reducing pneumonia, in participants&#xD;
      who accepted primary percutaneous coronary intervention (PCI) and at a high risk of&#xD;
      pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, prospective, randomized controlled study. All participants will be&#xD;
      followed up until 30 days after randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 30, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in inspiratory muscle strength</measure>
    <time_frame>at baseline, at 30 days</time_frame>
    <description>Static maximal inspiratory pressure (MIP) will be selected for the estimation of inspiratory muscle strength. A standard measurement using Powerbreathe® K5 and according to &quot;ERS Statement on Respiratory Muscle Testing at Rest and during Exercise&quot; published by European Respiratory Society (ERS) will be taken (Laveneziana, 2019). MIP test will be performed at baseline and at 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pneumonia</measure>
    <time_frame>up to 30 days</time_frame>
    <description>The diagnosis of pneumonia is based on guidelines of the American Thoracic Society [American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA), 2005]. The events of pneumonia will be followed and recorded by experienced doctors when in hospital. After discharged, participants will be followed by the experienced researches, once pneumonia is considered as possible, guidance will be provided for the participants to complete necessary examines, until 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events (MACE)</measure>
    <time_frame>up to 30 days</time_frame>
    <description>MACE is defined as: all cause death, recurrence of myocardial infarction, stroke at 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs of participants during training</measure>
    <time_frame>up to 30 days</time_frame>
    <description>The vital signs of participants during training in hospital will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfactory assessment</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Satisfaction of the participants in inspiratory muscle training (IMT) group will be evaluated using a questionnaire at the day of discharged and at 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>up to 120 days</time_frame>
    <description>Length of stay will be assessed by calculating the number of days the patient in the hospital.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Inspiratory muscle training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inspiratory muscle training (IMT) will be perform for 15 minutes each time, twice a day, training every day from 12h to 24h after primary percutaneous coronary intervention (PCI) to 30 days since randomized.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive standard care according to the current guideline and clinical practice after primary PCI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory Muscle Training</intervention_name>
    <description>The inspiratory muscle training (IMT) will be carried out with a load of 30% of maximal inspiratory pressure (MIP) using a threshold inspiratory muscle trainer (c-type, Shengchang medical equipment factory, Yuyao city, China) at the beginning. During the hospital period, the resistance will increase incrementally, based on the rate of perceived exertion scored on the Borg scale (Borg, 1982). If the rate of perceived exertion less than 5, the resistance of the inspiratory threshold trainer will then be increase incrementally by 5%. The load for home-based IMT training will be set as the highest training load in the hospital. All patients will be required in sitting position during training, wearing nose-clips.</description>
    <arm_group_label>Inspiratory muscle training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years, patients with AMI undergoing primary PCI, admitted to cardiac&#xD;
             intensive care unit and at a high pneumonia risk [2 or more of the following&#xD;
             parameters are regarded as high risk for pneumonia: 1. Age &gt; 55 years, 2. Diabetes&#xD;
             mellitus, 3. Smoking at present, 4. Chronic kidney disease: estimated glomerular&#xD;
             filtration rate &lt; 60 mL/min/1.73m2, 5. Forced expiratory volume in the first second of&#xD;
             expiration (FEV1) &lt; 80% predicted and FEV1/forced vital capacity (FVC) &lt; 70%&#xD;
             predicted]&#xD;
&#xD;
          -  be able to understand and agree with informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of cerebrovascular accident&#xD;
&#xD;
          -  treat with immunosuppressive medication for 30 days before&#xD;
&#xD;
          -  neuromuscular disorder&#xD;
&#xD;
          -  cardiovascular instability (such as aortic dissection or unstable hemodynamics)&#xD;
&#xD;
          -  a history of Coronary Artery Bypass Grafting (CABG)&#xD;
&#xD;
          -  expected survival is less than 6 months due to noncardiogenic disease&#xD;
&#xD;
          -  participated in other drugs and devices studies within 30 days&#xD;
&#xD;
          -  confirmed as ventricular aneurysm&#xD;
&#xD;
          -  other conditions not suit for the study after the discussion among the researchers&#xD;
             (eg: poor compliance, unable to cooperate for the training)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuanhui Liu, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial People's Hospital, Guangzhou, China.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuanhui Liu, MD, PHD</last_name>
    <phone>+86-13824440637</phone>
    <email>liuyuanhui@gdph.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuanhui Liu, MD, PHD</last_name>
      <phone>+86-13824440637</phone>
      <email>liuyuanhui@gdph.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.</citation>
    <PMID>7154893</PMID>
  </reference>
  <reference>
    <citation>Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.</citation>
    <PMID>30956204</PMID>
  </reference>
  <reference>
    <citation>American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.</citation>
    <PMID>15699079</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 4, 2021</last_update_submitted>
  <last_update_submitted_qc>February 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 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>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT04491760
org study id: No.GDREC2019521H(R1)
nct id: NCT04491760
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pneumonia is uncommon high among patients with acute myocardial infarction (AMI), which
      increases adverse clinical events and prolongs the hospital stay. Inspiratory muscle training
      (IMT) is able to improve inspiratory muscle strength and prevent pneumonia in patients
      undergoing cardiac surgery including coronary artery bypass grafting. Thus, the investigators
      design the study mainly aim to evaluate the 30 days IMT for the change of inspiratory muscle
      strength, and also to observe its potentially effect on reducing pneumonia, in participants
      who accepted primary percutaneous coronary intervention (PCI) and at a high risk of
      pneumonia.
This is a single center, prospective, randomized controlled study. All participants will be
      followed up until 30 days after randomized.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in inspiratory muscle strength
time frame: at baseline, at 30 days
description: Static maximal inspiratory pressure (MIP) will be selected for the estimation of inspiratory muscle strength. A standard measurement using Powerbreathe® K5 and according to "ERS Statement on Respiratory Muscle Testing at Rest and during Exercise" published by European Respiratory Society (ERS) will be taken (Laveneziana, 2019). MIP test will be performed at baseline and at 30 days.
measure: Pneumonia
time frame: up to 30 days
description: The diagnosis of pneumonia is based on guidelines of the American Thoracic Society [American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA), 2005]. The events of pneumonia will be followed and recorded by experienced doctors when in hospital. After discharged, participants will be followed by the experienced researches, once pneumonia is considered as possible, guidance will be provided for the participants to complete necessary examines, until 30 days.
measure: Major adverse cardiovascular events (MACE)
time frame: up to 30 days
description: MACE is defined as: all cause death, recurrence of myocardial infarction, stroke at 30 days.
measure: Vital signs of participants during training
time frame: up to 30 days
description: The vital signs of participants during training in hospital will be recorded.
measure: Satisfactory assessment
time frame: up to 30 days
description: Satisfaction of the participants in inspiratory muscle training (IMT) group will be evaluated using a questionnaire at the day of discharged and at 30 days.
measure: Length of stay
time frame: up to 120 days
description: Length of stay will be assessed by calculating the number of days the patient in the hospital.
arm group label: Inspiratory muscle training
arm group type: Experimental
description: Inspiratory muscle training (IMT) will be perform for 15 minutes each time, twice a day, training every day from 12h to 24h after primary percutaneous coronary intervention (PCI) to 30 days since randomized.
arm group label: Control group
arm group type: No Intervention
description: Participants will receive standard care according to the current guideline and clinical practice after primary PCI.
intervention type: Other
intervention name: Inspiratory Muscle Training
description: The inspiratory muscle training (IMT) will be carried out with a load of 30% of maximal inspiratory pressure (MIP) using a threshold inspiratory muscle trainer (c-type, Shengchang medical equipment factory, Yuyao city, China) at the beginning. During the hospital period, the resistance will increase incrementally, based on the rate of perceived exertion scored on the Borg scale (Borg, 1982). If the rate of perceived exertion less than 5, the resistance of the inspiratory threshold trainer will then be increase incrementally by 5%. The load for home-based IMT training will be set as the highest training load in the hospital. All patients will be required in sitting position during training, wearing nose-clips.
arm group label: Inspiratory muscle training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuanhui Liu, MD, PHD
role: Principal Investigator
affiliation: Guangdong Provincial People's Hospital, Guangzhou, China.
last name: Yuanhui Liu, MD, PHD
phone: +86-13824440637
email: liuyuanhui@gdph.org.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PMID: 7154893
citation: Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
PMID: 30956204
citation: American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
PMID: 15699079
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction