<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/NCT03258944</url>
  </required_header>
  <id_info>
    <org_study_id>VMTBS- HY</org_study_id>
    <nct_id>NCT03258944</nct_id>
  </id_info>
  <brief_title>Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters</brief_title>
  <official_title>Breath-Stacking and Ventilatory Muscle Strength</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Health Science of Porto Alegre</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>
      In several diseases in which muscle weakness is a determining factor for morbidity and&#xD;
      mortality, inspiratory muscle training has been shown to be useful in improving the function&#xD;
      of ventilatory muscles, delaying or minimizing the development of complications due to the&#xD;
      reduction of inspiratory muscle strength.&#xD;
&#xD;
      The breath-stacking technique emerges as an easily applicable alternative, and it can be used&#xD;
      in poorly collaborative patients. The technique described in the literature aims to increase&#xD;
      pulmonary volumes.&#xD;
&#xD;
      This gain occurs with the coupling of a silicone mask on the patient's face, a unidirectional&#xD;
      valve and with the expiratory branch occluded. Thus, inspirations occur sequentially in this&#xD;
      medium, generating pulmonary hyperinflation and increasing the contractility power of the&#xD;
      expiratory muscles, which are fundamental for coughing. This hyperinflation also improves the&#xD;
      peripheral air distribution in the lungs by increasing intrathoracic pressure.&#xD;
&#xD;
      The objective of this study is to evaluate the effect of the breath-stacking (BS) technique&#xD;
      on the ventilatory muscle strength of young and healthy individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Initially, participants will be submitted to a learning session on the evaluation of&#xD;
      ventilatory muscle strength and the breath-stacking technique. Between 24-72 hours after the&#xD;
      learning, the evaluation of the muscular muscular strength will be performed through the&#xD;
      maximal inspiratory pressure (MIP) and the maximum expiratory pressure (MEP). PI max will be&#xD;
      measured from a maximum expiration; While PE max will be measured from a maximum inspiration,&#xD;
      using a digital manovacuometer (MVD 300®)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ventilatory Muscle Strength</measure>
    <time_frame>four weeks</time_frame>
    <description>Maximum inspiratory and expiratory pressure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Breath-Stacking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be seated, with their elbows resting on the table, holding the face mask attached to a T-tube and a one-way valve. They will be instructed to inspire and force the expiration inside the mask. The training will be conducted three times a week for a period of four weeks, totaling twelve sessions. The breath-stacking application protocol will consist of three three-minute series, with a three-minute recovery interval between each series, obtaining a total time of fifteen minutes in each session</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breath-Stacking</intervention_name>
    <description>Participants will be seated, with their elbows resting on the table, holding the face mask attached to a T-tube and a one-way valve. They will be instructed to inspire and force the expiration inside the mask. The training will be conducted three times a week for a period of four weeks, totaling twelve sessions. The breath-stacking application protocol will consist of three three-minute series, with a three-minute recovery interval between each series, obtaining a total time of fifteen minutes in each session.</description>
    <arm_group_label>Breath-Stacking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No signs and symptoms of pulmonary diseases, normal ventilatory muscle strength and&#xD;
             agreement to participate and sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presenting neuromuscular diseases, claustrophobia, ruptured eardrum, history of&#xD;
             spontaneous pneumothorax and playing wind instruments or being a singer. Sample loss&#xD;
             will be considered as non-attendance at all training sessions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidade Federal de Ciências da Saúde de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90050-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
    <investigator_full_name>Fabrício Edler Macagnan</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</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/NCT03258944
org study id: VMTBS- HY
nct id: NCT03258944
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In several diseases in which muscle weakness is a determining factor for morbidity and
      mortality, inspiratory muscle training has been shown to be useful in improving the function
      of ventilatory muscles, delaying or minimizing the development of complications due to the
      reduction of inspiratory muscle strength.

      The breath-stacking technique emerges as an easily applicable alternative, and it can be used
      in poorly collaborative patients. The technique described in the literature aims to increase
      pulmonary volumes.

      This gain occurs with the coupling of a silicone mask on the patient's face, a unidirectional
      valve and with the expiratory branch occluded. Thus, inspirations occur sequentially in this
      medium, generating pulmonary hyperinflation and increasing the contractility power of the
      expiratory muscles, which are fundamental for coughing. This hyperinflation also improves the
      peripheral air distribution in the lungs by increasing intrathoracic pressure.

      The objective of this study is to evaluate the effect of the breath-stacking (BS) technique
      on the ventilatory muscle strength of young and healthy individuals.
Initially, participants will be submitted to a learning session on the evaluation of
      ventilatory muscle strength and the breath-stacking technique. Between 24-72 hours after the
      learning, the evaluation of the muscular muscular strength will be performed through the
      maximal inspiratory pressure (MIP) and the maximum expiratory pressure (MEP). PI max will be
      measured from a maximum expiration; While PE max will be measured from a maximum inspiration,
      using a digital manovacuometer (MVD 300®)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Ventilatory Muscle Strength
time frame: four weeks
description: Maximum inspiratory and expiratory pressure
arm group label: Breath-Stacking
arm group type: Experimental
description: Participants will be seated, with their elbows resting on the table, holding the face mask attached to a T-tube and a one-way valve. They will be instructed to inspire and force the expiration inside the mask. The training will be conducted three times a week for a period of four weeks, totaling twelve sessions. The breath-stacking application protocol will consist of three three-minute series, with a three-minute recovery interval between each series, obtaining a total time of fifteen minutes in each session
intervention type: Other
intervention name: Breath-Stacking
description: Participants will be seated, with their elbows resting on the table, holding the face mask attached to a T-tube and a one-way valve. They will be instructed to inspire and force the expiration inside the mask. The training will be conducted three times a week for a period of four weeks, totaling twelve sessions. The breath-stacking application protocol will consist of three three-minute series, with a three-minute recovery interval between each series, obtaining a total time of fifteen minutes in each session.
arm group label: Breath-Stacking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Health Science of Porto Alegre
investigator full name: Fabrício Edler Macagnan
investigator title: PhD
mesh term: Muscle Weakness
sharing ipd: No