<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/NCT02208830</url>
  </required_header>
  <id_info>
    <org_study_id>BCQPC</org_study_id>
    <nct_id>NCT02208830</nct_id>
  </id_info>
  <brief_title>Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program</brief_title>
  <acronym>PCBCQ</acronym>
  <official_title>Effects of Pulmonary Rehabilitation Associated With Respiratory Therapy vs Physiotherapy in Physical Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>InCor Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of this study is that the group of patients who will carry out the&#xD;
      rehabilitation program associated with respiratory therapy will have higher benefits in&#xD;
      physical function, peripheral muscle strength and quality of life compared to the group that&#xD;
      will only perform chest physiotherapy. Additionally, there will be a negative correlation&#xD;
      between inflammatory mediators and measures of physical ability as well as the magnitude of&#xD;
      improvement is lower after treatment in patients with higher baseline levels of inflammation.&#xD;
      Furthermore, these patients will be reevaluated in 1 and 3 years, as a cohort, studying if&#xD;
      exercise capacity may be a predictor of clinical and functional outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will have their dyspnea rated according to the Medical Research Council (MRC)&#xD;
      scale. The Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment test (CAT) will&#xD;
      also be applied.&#xD;
&#xD;
      Spirometry will be performed according to recommendations of the American Thoracic&#xD;
      Society/European Respiratory Society. The forced vital capacity and forced expiratory volume&#xD;
      values in the first second will be compared with those predicted for the Brazilian&#xD;
      population.&#xD;
&#xD;
      The maximal incremental cycle ergometer test will be carried out on an electromagnetically&#xD;
      braked cycle ergometer with gas exchange and ventilatory variables analyzed breath-by-breath.&#xD;
      After 2 min at rest and then 2 min pedaling in freewheel, the power (W) will continuously&#xD;
      increase in a linear &quot;ramp&quot; pattern (1 to 20 W/min).&#xD;
&#xD;
      The incremental treadmill test will be performed to determine aerobic training load. The&#xD;
      modified Balke protocol, according to the basal level of physical fitness (a total time&#xD;
      increment between eight and 12 minutes).&#xD;
&#xD;
      The incremental shuttle walking test will be conducted according to the description of Singh&#xD;
      et al.&#xD;
&#xD;
      The daily physical activity (DPA) will be assessed with an accelerometer for three days.&#xD;
&#xD;
      Blood sample for inflammatory markers measurements will be collected to analyze of IL-1 beta,&#xD;
      IL-6, IL-8, IL-10, TNF-alpha, using Duo Set ELISA kits from R &amp; D Systems according to&#xD;
      manufacturer's instructions.&#xD;
&#xD;
      Muscle strength with one repetition maximum (1RM) will be performed at middle deltoid (MD),&#xD;
      biceps brachial (BB) and quadriceps femoris (QF). The following movements will also be&#xD;
      evaluated: shoulder abduction, elbow flexion and knee extension.&#xD;
&#xD;
      Patients are going to be randomized to pulmonary rehabilitation or conventional physiotherapy&#xD;
      program as follow:&#xD;
&#xD;
      Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill and&#xD;
      lower limb strength training.&#xD;
&#xD;
      Conventional program: 8 week, twice weekly conventional program with: L'Expiration Lente&#xD;
      Totale Glotte Ouverte en decubitus Latéral (Eltgol), autogenous drainage (AD) and shaker with&#xD;
      duration of 30 minutes each.&#xD;
&#xD;
      Patients will be reassessed in 1 and 3 years, measuring maximal incremental cycle ergometer&#xD;
      test, incremental treadmill test, incremental shuttle walking test, accelerometer and muscle&#xD;
      strength. All tests will follow the same patterns as the first assesment. Adicionally,&#xD;
      exacerbations, hospitalization and survival in each year will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in exercise capacity in patients with bronchiectasis</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Exercise capacity is measured by maximal cardiopulmonary exercise test on a cycle ergometer. The protocol will be used in ramp.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulmonary Function</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>For the cohort follow up, forced expiratory volume in the first second will be primary outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exacerbations and Hospitalizations per year</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival in months</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>For the cohort follow up, the survival will be evaluated in months.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Peripheral muscle function is measured by</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>The maximal voluntary contraction in upper and lower limb was applied during the visits.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Bronchiectasis</condition>
  <arm_group>
    <arm_group_label>conventional program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pulmonary rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Duration of 8 week, twice weekly exercise program with: lower limb strength training and aerobic training per 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pulmonary rehabilitation</intervention_name>
    <description>Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill training and lower limb strength training.</description>
    <arm_group_label>pulmonary rehabilitation</arm_group_label>
    <other_name>exercise</other_name>
    <other_name>rehabilitation</other_name>
    <other_name>treatment</other_name>
    <other_name>pulmonary</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional program</intervention_name>
    <description>The conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes.</description>
    <arm_group_label>conventional program</arm_group_label>
    <other_name>physiotherapy</other_name>
    <other_name>treatment respiratory</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinical and / or CT of bronchiectasis without cystic fibrosis&#xD;
&#xD;
          -  Clinically stable (no change in symptoms of dyspnea, quantity and color of the&#xD;
             secretion)&#xD;
&#xD;
          -  Greater than 18 and / or oxygen dependent at home&#xD;
&#xD;
          -  Medical Research Council MRC ≥ 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers or smoking history&gt; 10 pack / years,&#xD;
&#xD;
          -  Cystic fibrosis (CF)&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Pulmonary fibrosis (PF)&#xD;
&#xD;
          -  Musculoskeletal limitations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anderson Alves de Camargo, master's</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nove de Julho</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rejane Agnelo Silva de Castro, Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nove de Julho</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Nove de Julho</name>
      <address>
        <city>São Paulo</city>
        <zip>01504001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>March 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 27, 2022</last_update_submitted>
  <last_update_submitted_qc>August 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Anderson Alves de Camargo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>bronchiectasis</keyword>
  <keyword>functional capacity</keyword>
  <keyword>lung functional</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiectasis</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/NCT02208830
org study id: BCQPC
nct id: NCT02208830
lead sponsor: 
collaborator: 
has dmc: Yes
The hypothesis of this study is that the group of patients who will carry out the
      rehabilitation program associated with respiratory therapy will have higher benefits in
      physical function, peripheral muscle strength and quality of life compared to the group that
      will only perform chest physiotherapy. Additionally, there will be a negative correlation
      between inflammatory mediators and measures of physical ability as well as the magnitude of
      improvement is lower after treatment in patients with higher baseline levels of inflammation.
      Furthermore, these patients will be reevaluated in 1 and 3 years, as a cohort, studying if
      exercise capacity may be a predictor of clinical and functional outcomes.
All patients will have their dyspnea rated according to the Medical Research Council (MRC)
      scale. The Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment test (CAT) will
      also be applied.

      Spirometry will be performed according to recommendations of the American Thoracic
      Society/European Respiratory Society. The forced vital capacity and forced expiratory volume
      values in the first second will be compared with those predicted for the Brazilian
      population.

      The maximal incremental cycle ergometer test will be carried out on an electromagnetically
      braked cycle ergometer with gas exchange and ventilatory variables analyzed breath-by-breath.
      After 2 min at rest and then 2 min pedaling in freewheel, the power (W) will continuously
      increase in a linear "ramp" pattern (1 to 20 W/min).

      The incremental treadmill test will be performed to determine aerobic training load. The
      modified Balke protocol, according to the basal level of physical fitness (a total time
      increment between eight and 12 minutes).

      The incremental shuttle walking test will be conducted according to the description of Singh
      et al.

      The daily physical activity (DPA) will be assessed with an accelerometer for three days.

      Blood sample for inflammatory markers measurements will be collected to analyze of IL-1 beta,
      IL-6, IL-8, IL-10, TNF-alpha, using Duo Set ELISA kits from R & D Systems according to
      manufacturer's instructions.

      Muscle strength with one repetition maximum (1RM) will be performed at middle deltoid (MD),
      biceps brachial (BB) and quadriceps femoris (QF). The following movements will also be
      evaluated: shoulder abduction, elbow flexion and knee extension.

      Patients are going to be randomized to pulmonary rehabilitation or conventional physiotherapy
      program as follow:

      Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill and
      lower limb strength training.

      Conventional program: 8 week, twice weekly conventional program with: L'Expiration Lente
      Totale Glotte Ouverte en decubitus Latéral (Eltgol), autogenous drainage (AD) and shaker with
      duration of 30 minutes each.

      Patients will be reassessed in 1 and 3 years, measuring maximal incremental cycle ergometer
      test, incremental treadmill test, incremental shuttle walking test, accelerometer and muscle
      strength. All tests will follow the same patterns as the first assesment. Adicionally,
      exacerbations, hospitalization and survival in each year will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: The change in exercise capacity in patients with bronchiectasis
time frame: Up to 36 months
description: Exercise capacity is measured by maximal cardiopulmonary exercise test on a cycle ergometer. The protocol will be used in ramp.
measure: Pulmonary Function
time frame: Up to 36 months
description: For the cohort follow up, forced expiratory volume in the first second will be primary outcome
measure: Exacerbations and Hospitalizations per year
time frame: Up to 36 months
description: For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated
measure: Survival in months
time frame: Up to 36 months
description: For the cohort follow up, the survival will be evaluated in months.
measure: Peripheral muscle function is measured by
time frame: Up to 36 months
description: The maximal voluntary contraction in upper and lower limb was applied during the visits.
arm group label: conventional program
arm group type: Experimental
description: The conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes.
arm group label: pulmonary rehabilitation
arm group type: Experimental
description: Duration of 8 week, twice weekly exercise program with: lower limb strength training and aerobic training per 30 minutes.
intervention type: Other
intervention name: pulmonary rehabilitation
description: Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill training and lower limb strength training.
arm group label: pulmonary rehabilitation
other name: exercise
other name: rehabilitation
other name: treatment
other name: pulmonary
intervention type: Other
intervention name: conventional program
description: The conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes.
arm group label: conventional program
other name: physiotherapy
other name: treatment respiratory
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anderson Alves de Camargo, master's
role: Principal Investigator
affiliation: University of Nove de Julho
last name: Rejane Agnelo Silva de Castro, Student
role: Principal Investigator
affiliation: University of Nove de Julho
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Anderson Alves de Camargo
investigator title: Principal Investigator
mesh term: Bronchiectasis