<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/NCT03042403</url>
  </required_header>
  <id_info>
    <org_study_id>CEP/UFU 364/11</org_study_id>
    <nct_id>NCT03042403</nct_id>
  </id_info>
  <brief_title>Effects of the Breath Stacking Technic in Healthy Individuals</brief_title>
  <official_title>Effects of the Breath Stacking Technic in Healthy Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Uberlandia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Uberlandia</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>
      This study aims to Analyze and compere the hemodynamic and respiratory variables before,&#xD;
      during and after the applying of technic as well as evaluate respiratory pressures generated&#xD;
      during applying of this same technic and correlate them with the effort noticed by device&#xD;
      user.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The breath stacking technic (BS) is an inspiratory maneuver used for recruitment of collapsed&#xD;
      alveoli and, consequently, improves oxygenation and, therefore, used by respiratory&#xD;
      physiotherapy aiming promoting lung re-expansion being. The BS was described by Marini as an&#xD;
      attempt of optimizing vital capacity in little co-operative individuals and hemodynamics has&#xD;
      been considered a way of incentive spirometry that provides high lung volume, in situations,&#xD;
      in which, inspiratory maneuver duration can be as important as the volume reached, composing&#xD;
      an alternative incentive of inspiration technic4. The system used is composed by an interface&#xD;
      (facial mask) connected to the patient, an inspiratory unidirectional valve and the&#xD;
      respiratory branch which is kept occluded during the carrying out of maneuvers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>maximum inspiratory and expiratory pressures</measure>
    <time_frame>During the intervention. They will be used to verify the average pressures generated during the execution of the technique. Time of the technique equal to 20 seconds.</time_frame>
    <description>connected to a manometer from brand Commercial Medica (Brazil) used to measure maximum inspiratory and expiratory pressures generated during carrying out of technic. The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified effort perception Borg scale</measure>
    <time_frame>Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.</time_frame>
    <description>applied to a modified effort perception Borg scale with a score from 0 to 10, considering 0 the smallest effort noticed and 10 the biggest effort reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.</time_frame>
    <description>by palpation method of radial artery, of respiratory frequency by direct counting of thoracic movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peripheral oxygen saturation</measure>
    <time_frame>Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.</time_frame>
    <description>through a pulse oximeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic arterial pressure</measure>
    <time_frame>Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.</time_frame>
    <description>the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic arterial pressure</measure>
    <time_frame>Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.</time_frame>
    <description>the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer from the brand Lamedial Commercial</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Hemodynamic Instability</condition>
  <arm_group>
    <arm_group_label>Breath stacking</arm_group_label>
    <description>During initial rest period, the volunteer remained seated for 10' in spontaneous breathing. During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds. During the 20 seconds of applying of technic, in the three series the maximum inspiratory and expiratory pressures reached during the carrying out of technic. In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breath stacking</intervention_name>
    <description>During initial rest period, the volunteer remained seated for 10' in spontaneous breathing. Right after, the measurement of arterial pressure, of SpO2 (%), of heart rate, of respiratory frequency and applied to a modified effort perception Borg. During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds, and the variables were assessement again the same variables of control. In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.</description>
    <arm_group_label>Breath stacking</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        52 healthy young volunteers The volunteers at the age of 18 to 30, sedentary: absence of&#xD;
        neuromuscular and/or cardiac respiratory diseases were included, the smokers, overweight,&#xD;
        claustrophobic or the ones with difficulty in carrying out the technic were excluded&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of 18 to 30, sedentary, absence of neuromuscular and/or cardiac respiratory&#xD;
             diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the smokers, overweight, claustrophobic or the ones with difficulty in carrying out&#xD;
             the technic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celia R Lopes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Uberlandia</affiliation>
  </overall_official>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Uberlandia</investigator_affiliation>
    <investigator_full_name>Luciene Aparecida José Vaz</investigator_full_name>
    <investigator_title>physiotherapist</investigator_title>
  </responsible_party>
  <keyword>hemodynamics</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>breath stacking</keyword>
  <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/NCT03042403
org study id: CEP/UFU 364/11
nct id: NCT03042403
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to Analyze and compere the hemodynamic and respiratory variables before,
      during and after the applying of technic as well as evaluate respiratory pressures generated
      during applying of this same technic and correlate them with the effort noticed by device
      user.
The breath stacking technic (BS) is an inspiratory maneuver used for recruitment of collapsed
      alveoli and, consequently, improves oxygenation and, therefore, used by respiratory
      physiotherapy aiming promoting lung re-expansion being. The BS was described by Marini as an
      attempt of optimizing vital capacity in little co-operative individuals and hemodynamics has
      been considered a way of incentive spirometry that provides high lung volume, in situations,
      in which, inspiratory maneuver duration can be as important as the volume reached, composing
      an alternative incentive of inspiration technic4. The system used is composed by an interface
      (facial mask) connected to the patient, an inspiratory unidirectional valve and the
      respiratory branch which is kept occluded during the carrying out of maneuvers.
observational model: Other
time perspective: Prospective
measure: maximum inspiratory and expiratory pressures
time frame: During the intervention. They will be used to verify the average pressures generated during the execution of the technique. Time of the technique equal to 20 seconds.
description: connected to a manometer from brand Commercial Medica (Brazil) used to measure maximum inspiratory and expiratory pressures generated during carrying out of technic. The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds.
measure: modified effort perception Borg scale
time frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
description: applied to a modified effort perception Borg scale with a score from 0 to 10, considering 0 the smallest effort noticed and 10 the biggest effort reported
measure: heart rate
time frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
description: by palpation method of radial artery, of respiratory frequency by direct counting of thoracic movement
measure: peripheral oxygen saturation
time frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
description: through a pulse oximeter
measure: systolic arterial pressure
time frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
description: the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer
measure: diastolic arterial pressure
time frame: Before, during and after the intervention. They will be used to compare the variation before, during and after the technique. Valuation time was 1 minute.
description: the measurement of systolic arterial pressure were assessed using an aneroid-type sphygmomanometer from the brand Lamedial Commercial
arm group label: Breath stacking
description: During initial rest period, the volunteer remained seated for 10' in spontaneous breathing. During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds. During the 20 seconds of applying of technic, in the three series the maximum inspiratory and expiratory pressures reached during the carrying out of technic. In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.
intervention type: Other
intervention name: Breath stacking
description: During initial rest period, the volunteer remained seated for 10' in spontaneous breathing. Right after, the measurement of arterial pressure, of SpO2 (%), of heart rate, of respiratory frequency and applied to a modified effort perception Borg. During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds, and the variables were assessement again the same variables of control. In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.
arm group label: Breath stacking
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Celia R Lopes
role: Principal Investigator
affiliation: Federal University of Uberlandia
responsible party type: Principal Investigator
investigator affiliation: Federal University of Uberlandia
investigator full name: Luciene Aparecida José Vaz
investigator title: physiotherapist
sharing ipd: No