<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/NCT04415788</url>
  </required_header>
  <id_info>
    <org_study_id>BrnoUH RHO AZVj 2021</org_study_id>
    <nct_id>NCT04415788</nct_id>
  </id_info>
  <brief_title>Inspiratory Muscle Training and COPD</brief_title>
  <official_title>Novel Versus Traditional Inspiratory Muscle Training Regimens as Home-based, Stand-alone Therapies in COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brno University Hospital</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>
      Subjects with chronic obstructive pulmonary disease (COPD) frequently develop considerable&#xD;
      deterioration in exercise capacity in association with weakness and deconditioning of the&#xD;
      respiratory muscles, which can be corrected with specific therapies. While pulmonary&#xD;
      rehabilitation is a central component in the rather complex manangement of COPD, there is&#xD;
      currently a lack of centers able to provide appropriate rehabilitation services in the Czech&#xD;
      Republic. The main objective of this study will be to fully evaluate the utility of the Test&#xD;
      of Incremental Respiratory Endurance (TIRE) as an at-home inspiratory muscle training method&#xD;
      in subjects with COPD, while comparing the effectiveness of this novel training approach to&#xD;
      the outcomes of more traditional ispiratory muscle training protocols.&#xD;
&#xD;
      This prospective, randomized controlled trial will include 2 treatment groups and 1 sham&#xD;
      intervention group in a 1:1:1 ratio. All participants will undergo a certain type of IMT&#xD;
      regardless of group assignment, which will be perfomed via two different devices. The trial&#xD;
      will comprise of an 8-week at-home training period with remote supervision followed by 4&#xD;
      months of unsupervised, independent inspiratory muscle training. Study outcomes will include&#xD;
      measures of inspiratory muscle strength and endurance, pulmonary function, COPD-specific&#xD;
      symptomatology, functional exercise capacity, surrogate markers of mortality risk, mental&#xD;
      health status and health-related quality of life of participants. While investigators&#xD;
      acknowledge the value of standard inspiratory muscle training protocols which use Threshold&#xD;
      devices, investigators believe that the TIRE training has the potential to provide additional&#xD;
      clinical benefits since it is able to modulate all aspects of muscular performance, including&#xD;
      strength, endurance and work capacity. Investigators hypothesize that, as a home-based&#xD;
      stand-alone rehabilitative therapy, TIRE will be superior to standard IMT in improving&#xD;
      COPD-related measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible participants will be randomly assigned to one of the following three distinct&#xD;
      home-based IMT protocols: (1) TIRE, (2) Standard, and (3) Sham (i.e. Low Resistance). All&#xD;
      subjects will undergo 8 weeks of daily unsupervised IMT using either a PrO2® device (Design&#xD;
      Net, Smithfield, USA) or Threshold device at home. All training modalities require the&#xD;
      subjects to be seated and wearing a nose clip while performing the required breaths. Subjects&#xD;
      will be instructed on respective training procedures and complete first training session in&#xD;
      the presence of a research team member upon enrollment. Regardless of training method,&#xD;
      participants will be instructed to fill in diary cards at the end of each training session,&#xD;
      in which participants document how many breaths were able to perform. This information will&#xD;
      be later used for compliance assessment. Participants will be also provided with user guides&#xD;
      developed by investigators research team with detailed instructions regarding equipment&#xD;
      set-up, training protocol and contact information. In addition, subjects will receive weekly&#xD;
      phone calls from week 0 to week 8 to encourage compliance and adherence to the study&#xD;
      protocol, to address any subject questions or concerns, and to collect information regarding&#xD;
      participants current symptomatology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2024</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained Maximal Inspiratory Pressure (SMIP)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>The primary outcome measure will be SMIP, which will be obtained along with MIP and ID in every subject using the PrO2® device, an electronic pressure manometer which utilizes wireless technology to connect to a tablet containing the software of the Test of Incremental Respiratory Endurance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal Inspiratory Pressure (MIP)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>MIP will be obtained from a maximal inspiratory effort from residual volume using the TIRE software and recorded in centimeters of water.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inspiratory Duration (ID)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>ID will be obtained from a maximal and sustained inspiratory effort using the TIRE software and recorded in seconds.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Forced expiratory volume in the first second (FEV1)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>FEV1 will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body</description>
  </other_outcome>
  <other_outcome>
    <measure>Inspiratory capacity (IC)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>IC will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body</description>
  </other_outcome>
  <other_outcome>
    <measure>Forced vital capacity (FVC)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>FVC will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body</description>
  </other_outcome>
  <other_outcome>
    <measure>Six-minute Walk Test (6MWT)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>Functional exercise capacity will be determined using the 6MWT. The best distance covered over a time of 6 minutes will be recorded in metres.</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Medical Research Council (mMRC) Dyspnea Scale</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>This scale ranges from zero to four, with higher scores indicating a greater degree of breathlessness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital Anxiety and Depression scale (HADS)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>The questionnaire comprises seven questions for anxiety and seven questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.</description>
  </other_outcome>
  <other_outcome>
    <measure>St.George's Respiratory Questionnaire (SGRQ)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.</description>
  </other_outcome>
  <other_outcome>
    <measure>COPD Assessment Test (CAT)</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>This instrument that can quantify the impact of COPD on the patient's health. The CAT has a scoring range of 0-40. Higher scores denote a more severe impact of COPD.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction - self-completed questionnaire</measure>
    <time_frame>Change from baseline to 8 weeks and 24 weeks</time_frame>
    <description>Subjects will be provided with a 5-item self-completed questionnaire developed by our research team that will measure their satisfaction with the intervention they received and the study in general. The items will be presented in the form of statements to which subjects will be asked to respond using a 1-5 Likert scale (&quot;strongly agree&quot;, &quot;agree&quot;, &quot;not sure&quot;, &quot;disagree&quot;, and strongly disagree&quot;).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Test of Incremental Respiratory Endurance - IMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training will consist of six levels (A-F) with six inspirations at each level for up to 36 breaths per session. TIRE data will be stored in the tablet and automatically synced to account on cloud-based online platform for subsequent interrogation and data retrieval. Before every training session, subjects will be required to complete one maximal and sustained inspiratory effort from which the training is based on for that day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Threshold - IMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects assigned to the Standard training regimen will receive a commonly used Threshold inspiratory muscle trainer. This device features a one-way spring-loaded valve at one end and a mouthpiece on the other through which subjects will be required to breathe in hard enough to overcome the resistance provided by the spring-loaded valve, allowing correct inspiration to happen. In other words, air flow is blocked until subjects generate sufficient inspiratory pressure to exceed the device pre-set pressure in cmH2O. The resistance will be set using the device's adjustable pressure setting which is fixed at 50% of the subject's MIP at the time of enrollment. The resistance will be readjusted as needed at week 4 to still reflect 50% of their inspiratory muscle strength at that time. Subjects will be coached to perform up to 36 breaths daily using the device. They will be also instructed to complete the training session within a 30-minute period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham IMT (Low resistence)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The Sham (Low Resistance) training regimen will use the same methods described above for the Standard IMT, except for the amount of resistance applied within the device. Subjects will receive a Threshold which has been set to its minimal resistance, which is 9 cmH2O. Again, subjects will be instructed to perform up to 36 breaths daily using the device within a 30-minute period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Test of Incremental Respiratory Endurance - IMT</intervention_name>
    <description>The TIRE training regimen will involve the use of a tablet provided to assigned subjects with the training software installed and a PrO2® device through which they will train. The software allows subjects to track their inspiratory muscle performance via real-time graphic representations of their efforts as training progresses.</description>
    <arm_group_label>Test of Incremental Respiratory Endurance - IMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Threshold - IMT</intervention_name>
    <description>The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.</description>
    <arm_group_label>Threshold - IMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham IMT (Low resistence)</intervention_name>
    <description>The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.</description>
    <arm_group_label>Sham IMT (Low resistence)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals over the age of 40&#xD;
&#xD;
          -  clinical and functional diagnosis of COPD&#xD;
&#xD;
          -  Global Initiative of Chronic Obstructive Lung Disease (GOLD) - stages I to IV&#xD;
&#xD;
          -  evidence of inspiratory muscle weakness, defined as a MIP ≤ 80 cmH2O and a SMIP ≤ 427&#xD;
             PTU&#xD;
&#xD;
          -  ability to operate a computer, tablet or smartphone&#xD;
&#xD;
          -  clinical stability with no history of infections or exacerbation of respiratory&#xD;
             symptoms for at least two months prior to study enrollment&#xD;
&#xD;
          -  non-participation in exercise programs in the past 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with history of lung surgery, lung cancer,&#xD;
&#xD;
          -  any diagnosed cognitive (i.e. Mini Mental State Examination score &lt; 24),&#xD;
&#xD;
          -  orthopedic, neurological or neuromuscular disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Filip Dosbaba, PT, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Brno, Czech Republic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ladislav Batalik, PT, PhD</last_name>
    <phone>00420532233123</phone>
    <email>batalik.ladislav@fnbrno.cz</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Brno</name>
      <address>
        <city>Brno</city>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ladislav Batalik</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.2147/COPD.S266234</url>
    <description>article link</description>
  </link>
  <reference>
    <citation>Formiga MF, Dosbaba F, Hartman M, Batalik L, Plutinsky M, Brat K, Ludka O, Cahalin LP. Novel versus Traditional Inspiratory Muscle Training Regimens as Home-Based, Stand-Alone Therapies in COPD: Protocol for a Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Sep 11;15:2147-2155. doi: 10.2147/COPD.S266234. eCollection 2020.</citation>
    <PMID>32982207</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brno University Hospital</investigator_affiliation>
    <investigator_full_name>Ladislav Batalik</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Chronic obstructive pulmonary disease</keyword>
  <keyword>Pulmonary rehabilitation</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Inspiratory muscle training</keyword>
  <keyword>Test of incremental respiratory endurance</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>
    <mesh_term>Respiratory Aspiration</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/NCT04415788
org study id: BrnoUH RHO AZVj 2021
nct id: NCT04415788
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Subjects with chronic obstructive pulmonary disease (COPD) frequently develop considerable
      deterioration in exercise capacity in association with weakness and deconditioning of the
      respiratory muscles, which can be corrected with specific therapies. While pulmonary
      rehabilitation is a central component in the rather complex manangement of COPD, there is
      currently a lack of centers able to provide appropriate rehabilitation services in the Czech
      Republic. The main objective of this study will be to fully evaluate the utility of the Test
      of Incremental Respiratory Endurance (TIRE) as an at-home inspiratory muscle training method
      in subjects with COPD, while comparing the effectiveness of this novel training approach to
      the outcomes of more traditional ispiratory muscle training protocols.

      This prospective, randomized controlled trial will include 2 treatment groups and 1 sham
      intervention group in a 1:1:1 ratio. All participants will undergo a certain type of IMT
      regardless of group assignment, which will be perfomed via two different devices. The trial
      will comprise of an 8-week at-home training period with remote supervision followed by 4
      months of unsupervised, independent inspiratory muscle training. Study outcomes will include
      measures of inspiratory muscle strength and endurance, pulmonary function, COPD-specific
      symptomatology, functional exercise capacity, surrogate markers of mortality risk, mental
      health status and health-related quality of life of participants. While investigators
      acknowledge the value of standard inspiratory muscle training protocols which use Threshold
      devices, investigators believe that the TIRE training has the potential to provide additional
      clinical benefits since it is able to modulate all aspects of muscular performance, including
      strength, endurance and work capacity. Investigators hypothesize that, as a home-based
      stand-alone rehabilitative therapy, TIRE will be superior to standard IMT in improving
      COPD-related measures.
Eligible participants will be randomly assigned to one of the following three distinct
      home-based IMT protocols: (1) TIRE, (2) Standard, and (3) Sham (i.e. Low Resistance). All
      subjects will undergo 8 weeks of daily unsupervised IMT using either a PrO2® device (Design
      Net, Smithfield, USA) or Threshold device at home. All training modalities require the
      subjects to be seated and wearing a nose clip while performing the required breaths. Subjects
      will be instructed on respective training procedures and complete first training session in
      the presence of a research team member upon enrollment. Regardless of training method,
      participants will be instructed to fill in diary cards at the end of each training session,
      in which participants document how many breaths were able to perform. This information will
      be later used for compliance assessment. Participants will be also provided with user guides
      developed by investigators research team with detailed instructions regarding equipment
      set-up, training protocol and contact information. In addition, subjects will receive weekly
      phone calls from week 0 to week 8 to encourage compliance and adherence to the study
      protocol, to address any subject questions or concerns, and to collect information regarding
      participants current symptomatology.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Sustained Maximal Inspiratory Pressure (SMIP)
time frame: Change from baseline to 8 weeks and 24 weeks
description: The primary outcome measure will be SMIP, which will be obtained along with MIP and ID in every subject using the PrO2® device, an electronic pressure manometer which utilizes wireless technology to connect to a tablet containing the software of the Test of Incremental Respiratory Endurance.
measure: Maximal Inspiratory Pressure (MIP)
time frame: Change from baseline to 8 weeks and 24 weeks
description: MIP will be obtained from a maximal inspiratory effort from residual volume using the TIRE software and recorded in centimeters of water.
measure: Inspiratory Duration (ID)
time frame: Change from baseline to 8 weeks and 24 weeks
description: ID will be obtained from a maximal and sustained inspiratory effort using the TIRE software and recorded in seconds.
measure: Forced expiratory volume in the first second (FEV1)
time frame: Change from baseline to 8 weeks and 24 weeks
description: FEV1 will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body
measure: Inspiratory capacity (IC)
time frame: Change from baseline to 8 weeks and 24 weeks
description: IC will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body
measure: Forced vital capacity (FVC)
time frame: Change from baseline to 8 weeks and 24 weeks
description: FVC will be obtained from pulmonary function tests which comprise post-bronchodilator spirometry using SpiroScout® and whole-body plethysmography using the PowerCube® Body
measure: Six-minute Walk Test (6MWT)
time frame: Change from baseline to 8 weeks and 24 weeks
description: Functional exercise capacity will be determined using the 6MWT. The best distance covered over a time of 6 minutes will be recorded in metres.
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
time frame: Change from baseline to 8 weeks and 24 weeks
description: This scale ranges from zero to four, with higher scores indicating a greater degree of breathlessness.
measure: Hospital Anxiety and Depression scale (HADS)
time frame: Change from baseline to 8 weeks and 24 weeks
description: The questionnaire comprises seven questions for anxiety and seven questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
measure: St.George's Respiratory Questionnaire (SGRQ)
time frame: Change from baseline to 8 weeks and 24 weeks
description: The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.
measure: COPD Assessment Test (CAT)
time frame: Change from baseline to 8 weeks and 24 weeks
description: This instrument that can quantify the impact of COPD on the patient's health. The CAT has a scoring range of 0-40. Higher scores denote a more severe impact of COPD.
measure: Satisfaction - self-completed questionnaire
time frame: Change from baseline to 8 weeks and 24 weeks
description: Subjects will be provided with a 5-item self-completed questionnaire developed by our research team that will measure their satisfaction with the intervention they received and the study in general. The items will be presented in the form of statements to which subjects will be asked to respond using a 1-5 Likert scale ("strongly agree", "agree", "not sure", "disagree", and strongly disagree").
arm group label: Test of Incremental Respiratory Endurance - IMT
arm group type: Experimental
description: Training will consist of six levels (A-F) with six inspirations at each level for up to 36 breaths per session. TIRE data will be stored in the tablet and automatically synced to account on cloud-based online platform for subsequent interrogation and data retrieval. Before every training session, subjects will be required to complete one maximal and sustained inspiratory effort from which the training is based on for that day.
arm group label: Threshold - IMT
arm group type: Experimental
description: Subjects assigned to the Standard training regimen will receive a commonly used Threshold inspiratory muscle trainer. This device features a one-way spring-loaded valve at one end and a mouthpiece on the other through which subjects will be required to breathe in hard enough to overcome the resistance provided by the spring-loaded valve, allowing correct inspiration to happen. In other words, air flow is blocked until subjects generate sufficient inspiratory pressure to exceed the device pre-set pressure in cmH2O. The resistance will be set using the device's adjustable pressure setting which is fixed at 50% of the subject's MIP at the time of enrollment. The resistance will be readjusted as needed at week 4 to still reflect 50% of their inspiratory muscle strength at that time. Subjects will be coached to perform up to 36 breaths daily using the device. They will be also instructed to complete the training session within a 30-minute period.
arm group label: Sham IMT (Low resistence)
arm group type: Sham Comparator
description: The Sham (Low Resistance) training regimen will use the same methods described above for the Standard IMT, except for the amount of resistance applied within the device. Subjects will receive a Threshold which has been set to its minimal resistance, which is 9 cmH2O. Again, subjects will be instructed to perform up to 36 breaths daily using the device within a 30-minute period.
intervention type: Device
intervention name: Test of Incremental Respiratory Endurance - IMT
description: The TIRE training regimen will involve the use of a tablet provided to assigned subjects with the training software installed and a PrO2® device through which they will train. The software allows subjects to track their inspiratory muscle performance via real-time graphic representations of their efforts as training progresses.
arm group label: Test of Incremental Respiratory Endurance - IMT
intervention type: Device
intervention name: Threshold - IMT
description: The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.
arm group label: Threshold - IMT
intervention type: Device
intervention name: Sham IMT (Low resistence)
description: The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.
arm group label: Sham IMT (Low resistence)
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Filip Dosbaba, PT, PhD
role: Study Director
affiliation: University Hospital Brno, Czech Republic
last name: Ladislav Batalik, PT, PhD
phone: 00420532233123
email: batalik.ladislav@fnbrno.cz
facility: 
status: Recruiting
contact: 
country: Czechia
url: https://doi.org/10.2147/COPD.S266234
description: article link
citation: Formiga MF, Dosbaba F, Hartman M, Batalik L, Plutinsky M, Brat K, Ludka O, Cahalin LP. Novel versus Traditional Inspiratory Muscle Training Regimens as Home-Based, Stand-Alone Therapies in COPD: Protocol for a Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Sep 11;15:2147-2155. doi: 10.2147/COPD.S266234. eCollection 2020.
PMID: 32982207
responsible party type: Principal Investigator
investigator affiliation: Brno University Hospital
investigator full name: Ladislav Batalik
investigator title: Principal investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Respiratory Aspiration