<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/NCT02203058</url>
  </required_header>
  <id_info>
    <org_study_id>PLB2014</org_study_id>
    <nct_id>NCT02203058</nct_id>
  </id_info>
  <brief_title>Pursed-lips Breathing and Dynamic Hyperinflation</brief_title>
  <official_title>Pursed-lips Breathing Reduces Reduces Dynamic Hyperinflation Induced by Activities of Daily Living Test in Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the State of Santa Catarina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the State of Santa Catarina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and&#xD;
      consequent limitations in functional capacity of chronic obstructive pulmonary disease (COPD)&#xD;
      patients. It has not been completely elucidated whether pursed-lips breathing (PLB) is able&#xD;
      to minimize DH and its effects on exercise tolerance in these patients. The aim of this study&#xD;
      was to evaluate the acute effect of PLB on DH and functional capacity in patients with COPD.&#xD;
&#xD;
      Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient&#xD;
      pulmonary rehabilitation program in Florianópolis, Brazil.&#xD;
&#xD;
      Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)%&#xD;
      predicted, BMI=27.6 (5.13)kg/m2).&#xD;
&#xD;
      Interventions: Patients will randomly perform two six-minute walk tests with and without PLB&#xD;
      (6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and&#xD;
      TGlittreNon-PLB).&#xD;
&#xD;
      Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC)&#xD;
      will be assessed by the slow vital capacity (SVC) maneuver.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary function testing Lung function will be tested using an Easy One spirometer (NDD&#xD;
      Medical Technologies Inc., Zurich, Switzerland), and calibration checked before each&#xD;
      evaluation. Spirometry will be performed in accordance with ATS/ERS standards (Miller et al,&#xD;
      2005). The predicted values will be calculated from the equations proposed by Pereira et al.&#xD;
      (2007).&#xD;
&#xD;
      Inspiratory capacity (IC) measurement IC will be measured with the patient in the sitting&#xD;
      position, using an Easy One portable spirometer (NDD Medical Technologies Inc., Zurich,&#xD;
      Switzerland), before and immediately after the tests, by the slow vital capacity maneuver&#xD;
      starting from a stable end-expiratory volume, in accordance with ATS/ERS standards (Miller et&#xD;
      al,2005). A minimum of three maneuvers (maximum of eight) will be performed and, in order to&#xD;
      be considered reproducible, two curves could not vary by more than 5% or 150mL. The higher&#xD;
      value of two reproducible curves will be used for analysis. DH is considered when the IC&#xD;
      decreased 10% and/or 150mL or more compared to the basal value (O'Donnell et al, 2001).&#xD;
&#xD;
      Six-minute walk test The 6MWT will be performed according to the guidelines of the American&#xD;
      Thoracic Society (2002). Pulse oxygen saturation (SpO2; Oxi-Go, Oximeter Plus, Roslyn&#xD;
      Heights, New York, USA) and dyspnea (Borg CR10 scale) will be measured at the beginning and&#xD;
      at the end of the test. Predicted values for walking distance will be calculated according to&#xD;
      Iwama et al. (2009).&#xD;
&#xD;
      Glittre-ADL test The TGlittre consists of completing a circuit as follows: from a sitting&#xD;
      position, the subject stands up and walks along a flat 10-m long course, in the middle of&#xD;
      which there is a two-step ladder (each step 17 cm high x 27 cm deep) to be climbed; after&#xD;
      completing the 10 m, the subject faces a shelf containing three 1-kg objects positioned on&#xD;
      the top shelf (shoulder height) and moves them one by one to the bottom shelf (waist height)&#xD;
      and then to the floor; the objects are then returned to the bottom shelf and finally to the&#xD;
      top shelf again; the subject walks back, climbing up and down the steps, until reaching the&#xD;
      starting point (chair), sits down and immediately begins the next lap. The subjects carry a&#xD;
      weighted backpack (2.5 kg for women, 5.0 kg for men) and are instructed to complete five laps&#xD;
      on this circuit as quickly as possible. SpO2 and dyspnea index (Borg CR10 scale) will be&#xD;
      measured at the beginning of the test, at the end of each lap, and at the end of the test&#xD;
      (Skumlien et al, 2006).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dynamic hyperinflation</measure>
    <time_frame>At the beginning and immediately after de six-minute walk test and Glittre ADL test.</time_frame>
    <description>Effect of pursed-lips breathing on inspiratory capacity during the six-minute walk test and Glittre-ADL test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Six-minute walk test performance</measure>
    <time_frame>Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.</time_frame>
    <description>Effect of pursed-lips breathing on the distance walked (meters) during the six-minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glittre-ADL test performance</measure>
    <time_frame>Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.</time_frame>
    <description>Effect of pursed-lips breathing on the time spent (minutes) performing the Glittre-ADL tes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Pursed-lips breathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients performed both tests (six-minute walk test and Glittre ADL test) with pursed-lips breathing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No pursed-lips breathing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>All patients performed both tests (six-minute walk test and Glittre ADL test) without pursed-lips breathing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pursed-lips breathing</intervention_name>
    <description>Expiration with pursed-lips during functional capacity tests.</description>
    <arm_group_label>Pursed-lips breathing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No pursed-lips breathing</intervention_name>
    <description>To avoid pursed-lips breathing, subjects use a a mouthpiece (2cm diameter X 2cm length) such as the one used in pulmonary functional tests.</description>
    <arm_group_label>No pursed-lips breathing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD GOLD stages 2, 3, and 4 of severity of airflow limitation&#xD;
&#xD;
          -  history of smoking ≥ 20 pack-years&#xD;
&#xD;
          -  clinical stability in the four weeks prior to the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  long-term oxygen therapy&#xD;
&#xD;
          -  current smoking&#xD;
&#xD;
          -  any pulmonary disease other than COPD&#xD;
&#xD;
          -  comorbidities that would compromise their ability to perform any of the evaluations in&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anamaria F Mayer, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade do Estado de Santa Catraina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Núcleo de Aisstência, Ensino e Pesquisa em Reabilitação Pulmonar</name>
      <address>
        <city>Florianópolis</city>
        <state>Santa Catarina</state>
        <zip>88080-350</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.</citation>
    <PMID>16055882</PMID>
  </reference>
  <reference>
    <citation>Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.</citation>
    <PMID>17982531</PMID>
  </reference>
  <reference>
    <citation>O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.</citation>
    <PMID>11549531</PMID>
  </reference>
  <reference>
    <citation>Iwama AM, Andrade GN, Shima P, Tanni SE, Godoy I, Dourado VZ. The six-minute walk test and body weight-walk distance product in healthy Brazilian subjects. Braz J Med Biol Res. 2009 Nov;42(11):1080-5. doi: 10.1590/s0100-879x2009005000032. Epub 2009 Oct 2. Erratum In: Braz J Med Biol Res. 2010 Mar;43(3):324.</citation>
    <PMID>19802464</PMID>
  </reference>
  <reference>
    <citation>ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.</citation>
    <PMID>12091180</PMID>
  </reference>
  <reference>
    <citation>Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.</citation>
    <PMID>15941658</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of the State of Santa Catarina</investigator_affiliation>
    <investigator_full_name>Prof. Dra. Anamaria Fleig Mayer</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Inspiratory capacity</keyword>
  <keyword>Positive-pressure respiration</keyword>
  <keyword>Exercise</keyword>
  <keyword>Activities of daily living</keyword>
  <keyword>COPD.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02203058
org study id: PLB2014
nct id: NCT02203058
lead sponsor: 
has dmc: No
Background: Dynamic hyperinflation (DH) is an important factor leading to dyspnea and
      consequent limitations in functional capacity of chronic obstructive pulmonary disease (COPD)
      patients. It has not been completely elucidated whether pursed-lips breathing (PLB) is able
      to minimize DH and its effects on exercise tolerance in these patients. The aim of this study
      was to evaluate the acute effect of PLB on DH and functional capacity in patients with COPD.

      Design: Randomized cross-over study. Setting: The study will be conducted in an outpatient
      pulmonary rehabilitation program in Florianópolis, Brazil.

      Subjects: Twenty-five patients with COPD (16 men, mean age 64 (7) years, FEV1=41.7 (14.7)%
      predicted, BMI=27.6 (5.13)kg/m2).

      Interventions: Patients will randomly perform two six-minute walk tests with and without PLB
      (6MWTPLB and 6MWTNon-PLB) and two Glittre-ADL tests with and without PLB (TGlittrePLB and
      TGlittreNon-PLB).

      Main measures: At baseline and immediately after the tests, the inspiratory capacity (IC)
      will be assessed by the slow vital capacity (SVC) maneuver.
Pulmonary function testing Lung function will be tested using an Easy One spirometer (NDD
      Medical Technologies Inc., Zurich, Switzerland), and calibration checked before each
      evaluation. Spirometry will be performed in accordance with ATS/ERS standards (Miller et al,
      2005). The predicted values will be calculated from the equations proposed by Pereira et al.
      (2007).

      Inspiratory capacity (IC) measurement IC will be measured with the patient in the sitting
      position, using an Easy One portable spirometer (NDD Medical Technologies Inc., Zurich,
      Switzerland), before and immediately after the tests, by the slow vital capacity maneuver
      starting from a stable end-expiratory volume, in accordance with ATS/ERS standards (Miller et
      al,2005). A minimum of three maneuvers (maximum of eight) will be performed and, in order to
      be considered reproducible, two curves could not vary by more than 5% or 150mL. The higher
      value of two reproducible curves will be used for analysis. DH is considered when the IC
      decreased 10% and/or 150mL or more compared to the basal value (O'Donnell et al, 2001).

      Six-minute walk test The 6MWT will be performed according to the guidelines of the American
      Thoracic Society (2002). Pulse oxygen saturation (SpO2; Oxi-Go, Oximeter Plus, Roslyn
      Heights, New York, USA) and dyspnea (Borg CR10 scale) will be measured at the beginning and
      at the end of the test. Predicted values for walking distance will be calculated according to
      Iwama et al. (2009).

      Glittre-ADL test The TGlittre consists of completing a circuit as follows: from a sitting
      position, the subject stands up and walks along a flat 10-m long course, in the middle of
      which there is a two-step ladder (each step 17 cm high x 27 cm deep) to be climbed; after
      completing the 10 m, the subject faces a shelf containing three 1-kg objects positioned on
      the top shelf (shoulder height) and moves them one by one to the bottom shelf (waist height)
      and then to the floor; the objects are then returned to the bottom shelf and finally to the
      top shelf again; the subject walks back, climbing up and down the steps, until reaching the
      starting point (chair), sits down and immediately begins the next lap. The subjects carry a
      weighted backpack (2.5 kg for women, 5.0 kg for men) and are instructed to complete five laps
      on this circuit as quickly as possible. SpO2 and dyspnea index (Borg CR10 scale) will be
      measured at the beginning of the test, at the end of each lap, and at the end of the test
      (Skumlien et al, 2006).
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Dynamic hyperinflation
time frame: At the beginning and immediately after de six-minute walk test and Glittre ADL test.
description: Effect of pursed-lips breathing on inspiratory capacity during the six-minute walk test and Glittre-ADL test.
measure: Six-minute walk test performance
time frame: Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
description: Effect of pursed-lips breathing on the distance walked (meters) during the six-minute walk test.
measure: Glittre-ADL test performance
time frame: Both tests (with and without pursed-lips breathing) will be held at least two days to one week apart.
description: Effect of pursed-lips breathing on the time spent (minutes) performing the Glittre-ADL tes.
arm group label: Pursed-lips breathing
arm group type: Experimental
description: All patients performed both tests (six-minute walk test and Glittre ADL test) with pursed-lips breathing.
arm group label: No pursed-lips breathing
arm group type: Placebo Comparator
description: All patients performed both tests (six-minute walk test and Glittre ADL test) without pursed-lips breathing.
intervention type: Other
intervention name: Pursed-lips breathing
description: Expiration with pursed-lips during functional capacity tests.
arm group label: Pursed-lips breathing
intervention type: Other
intervention name: No pursed-lips breathing
description: To avoid pursed-lips breathing, subjects use a a mouthpiece (2cm diameter X 2cm length) such as the one used in pulmonary functional tests.
arm group label: No pursed-lips breathing
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anamaria F Mayer, PhD
role: Study Director
affiliation: Universidade do Estado de Santa Catraina
facility: 
country: Brazil
citation: Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PMID: 16055882
citation: Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
PMID: 17982531
citation: O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
PMID: 11549531
citation: Iwama AM, Andrade GN, Shima P, Tanni SE, Godoy I, Dourado VZ. The six-minute walk test and body weight-walk distance product in healthy Brazilian subjects. Braz J Med Biol Res. 2009 Nov;42(11):1080-5. doi: 10.1590/s0100-879x2009005000032. Epub 2009 Oct 2. Erratum In: Braz J Med Biol Res. 2010 Mar;43(3):324.
PMID: 19802464
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
PMID: 12091180
citation: Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.
PMID: 15941658
responsible party type: Principal Investigator
investigator affiliation: University of the State of Santa Catarina
investigator full name: Prof. Dra. Anamaria Fleig Mayer
investigator title: PhD
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive