<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/NCT02200198</url>
  </required_header>
  <id_info>
    <org_study_id>0613/07</org_study_id>
    <nct_id>NCT02200198</nct_id>
  </id_info>
  <brief_title>Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery</brief_title>
  <official_title>Effect of Respiratory Muscle Training in Malnourished Patients Undergoing Upper Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malnutrition affects 50% of hospitalized patients around the world and causes changes in&#xD;
      respiratory muscles predisposing the development of pulmonary complications probable, because&#xD;
      of the ineffectiveness of cough. How the training of respiratory muscles can improve the&#xD;
      effectiveness of cough, malnourished patients could benefit from this train however, the&#xD;
      training of the muscles in malnourished patients has not been tested for safety or&#xD;
      efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory&#xD;
      muscle training to improve the potency of cough in malnourished patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Expiratory peak flow in spirometry</measure>
    <time_frame>on the 8th day of protocol (after 7 dyas of training)</time_frame>
    <description>Assessed as expiratory peak flow in spirometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum respiratory pressures</measure>
    <time_frame>on the 8th day of protocol (after 7 days of training)</time_frame>
    <description>Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pulmonary complication</measure>
    <time_frame>participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days</time_frame>
    <description>The following pulmonary complications were considered: atelectasis with clinical consequences, hypoxemia with oxygen saturation &lt;85%, and need for supplemental oxygen, pneumonia and acute respiratory failure.&#xD;
The diagnosis of complication was performed by a physician who was blinded to the intervention group.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Undernutrition</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Inspiratory group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inspiratory muscle training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expiratory group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Expiratory muscle training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Expiratory muscle training</intervention_name>
    <description>Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold with Positive Expiratory Pressure with a load of 30% of maximal expiratory pressure assessed by digital peak respiratory pressure monitor</description>
    <arm_group_label>Expiratory group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory muscle training</intervention_name>
    <description>Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold for Inspiratory Muscle Training with a load of 30% of maximal inspiratory pressure assessed by digital peak respiratory pressure monitor</description>
    <arm_group_label>Inspiratory group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham group</intervention_name>
    <description>Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load</description>
    <arm_group_label>Sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hospitalized malnourished patients (BMI ≤ 20 Kg/m2, loss of body weight ≥ 10%&#xD;
             unintentional, or serum albumin &lt;3.5 g/dL)&#xD;
&#xD;
          -  candidate to elective abdominal surgery&#xD;
&#xD;
          -  ability to perform all evaluations and training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous respiratory disease&#xD;
&#xD;
          -  necessity of over than 48h of mechanical ventilation&#xD;
&#xD;
          -  reoperation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celso RF Carvalho, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of Clinics of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>undernutrition</keyword>
  <keyword>abdominal surgery</keyword>
  <keyword>respiratory muscles</keyword>
  <keyword>muscles strength</keyword>
  <keyword>pulmonary complication</keyword>
  <keyword>perioperative care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT02200198
org study id: 0613/07
nct id: NCT02200198
lead sponsor: 
has dmc: No
Malnutrition affects 50% of hospitalized patients around the world and causes changes in
      respiratory muscles predisposing the development of pulmonary complications probable, because
      of the ineffectiveness of cough. How the training of respiratory muscles can improve the
      effectiveness of cough, malnourished patients could benefit from this train however, the
      training of the muscles in malnourished patients has not been tested for safety or
      efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory
      muscle training to improve the potency of cough in malnourished patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Expiratory peak flow in spirometry
time frame: on the 8th day of protocol (after 7 dyas of training)
description: Assessed as expiratory peak flow in spirometry
measure: Maximum respiratory pressures
time frame: on the 8th day of protocol (after 7 days of training)
description: Assessed by digital peak respiratory pressure monitor as maximum inspiratory pressure and maximum expiratory pressure
measure: Postoperative pulmonary complication
time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 10 days
description: The following pulmonary complications were considered: atelectasis with clinical consequences, hypoxemia with oxygen saturation <85%, and need for supplemental oxygen, pneumonia and acute respiratory failure.
The diagnosis of complication was performed by a physician who was blinded to the intervention group.
arm group label: Inspiratory group
arm group type: Active Comparator
description: Inspiratory muscle training
arm group label: Sham group
arm group type: Sham Comparator
description: Sham training
arm group label: Expiratory group
arm group type: Experimental
description: Expiratory muscle training
intervention type: Other
intervention name: Expiratory muscle training
description: Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold with Positive Expiratory Pressure with a load of 30% of maximal expiratory pressure assessed by digital peak respiratory pressure monitor
arm group label: Expiratory group
intervention type: Other
intervention name: Inspiratory muscle training
description: Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold for Inspiratory Muscle Training with a load of 30% of maximal inspiratory pressure assessed by digital peak respiratory pressure monitor
arm group label: Inspiratory group
intervention type: Other
intervention name: Sham group
description: Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load
arm group label: Sham group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Celso RF Carvalho, PhD
role: Study Director
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Malnutrition