<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/NCT03041155</url>
  </required_header>
  <id_info>
    <org_study_id>43697715.0.0000.5054</org_study_id>
    <nct_id>NCT03041155</nct_id>
    <nct_alias>NCT03075982</nct_alias>
  </id_info>
  <brief_title>Respiratory Muscle Training in Hemodialysis Patients</brief_title>
  <official_title>Respiratory Muscle Training in Hemodialysis Patients: Effects on Physiologic Parameters and Endothelium-related Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Ceara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Ceara</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>
      The research protocol is a Randomized Clinical Trial that has the effectiveness of a given&#xD;
      respiratory muscle training protocol over the indicative variables: Pulmonary function;&#xD;
      Markers of oxidative stress and inflammation, endothelial markers and Quality of life in&#xD;
      patients with chronic kidney disease undergoing hemodialysis. According to the Investigators,&#xD;
      this topic was proposed since it is known that several pulmonary complications occur as a&#xD;
      consequence of chronic kidney disease due to uremic myopathy. Therefore, the hypothesis is&#xD;
      that the application of a respiratory muscle training protocol will contribute positively&#xD;
      pulmonary functionality and a decrease in oxidative stress and inflammation in chronic kidney&#xD;
      patients, consequently, will bring improvement in the quality of life for these patients. The&#xD;
      Patients will be divided into two groups: control group - No intervention of the Muscular&#xD;
      Training (CG) And Intervention Group (GI). The intervention protocol will be composed of&#xD;
      respiratory muscle training And lasts for two (2) months, with three (3) visits per week. It&#xD;
      will be carried out through Threshold PeP appliance. The twelve (12) first training sessions&#xD;
      will have a total duration of 30 minutes 15 minutes with inspiratory load of 20 cmH2O and 15&#xD;
      minutes with expiratory load of 20 CmH 2 O; and the others (12) twelve sessions will last 40&#xD;
      minutes each, with 20 minutes with an inspiratory load of 20 CmH2O and 20 minutes with&#xD;
      expiratory load of 20 cmH2O. The variables evaluated will be: muscular strength Respiratory&#xD;
      (maximum inspiratory pressure and maximum expiratory pressure - Pimáx and Pemáx); Lung&#xD;
      function (Slow Vital Capacity - CVL, forced expiratory volume in the first minute - VEF1,&#xD;
      Vital Capacity Forced - CVF and Maximum Voluntary Ventilation - VVM); Serum levels of&#xD;
      oxidative stress markers, endothelial markers and endothelin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">April 20, 2017</completion_date>
  <primary_completion_date type="Actual">April 20, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>endothelium glycocalyx biomarkers</measure>
    <time_frame>8 weeks</time_frame>
    <description>plasma syndecan-1 (ng/mL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endothelium biomarker</measure>
    <time_frame>8 weeks</time_frame>
    <description>ICAM (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endotehlium Biomarker</measure>
    <time_frame>8 weeks</time_frame>
    <description>VCAM(ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aberrant angiogenesis</measure>
    <time_frame>8 weeks</time_frame>
    <description>Angiopoietin-2 (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>8 weeks</time_frame>
    <description>Plasma Malondialdehyde (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean blood pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Blood pressure (mmHg)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Muscle respiratory training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Muscle respiratory training</intervention_name>
    <description>Muscle respiratory training during hemodialysis sessions</description>
    <arm_group_label>treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Maintenance hemodialysis for more than 3 months&#xD;
&#xD;
          -  No COPD diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decompensated Heart failure&#xD;
&#xD;
          -  Acute coronary disease in the last 3 months&#xD;
&#xD;
          -  Active infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre Liborio, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Ceara</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pronefron</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60165082</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>July 15, 2017</last_update_submitted>
  <last_update_submitted_qc>July 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Ceara</investigator_affiliation>
    <investigator_full_name>Alexandre Braga Liborio</investigator_full_name>
    <investigator_title>Visitant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</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/NCT03041155
org study id: 43697715.0.0000.5054
nct id: NCT03041155
nct alias: NCT03075982
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research protocol is a Randomized Clinical Trial that has the effectiveness of a given
      respiratory muscle training protocol over the indicative variables: Pulmonary function;
      Markers of oxidative stress and inflammation, endothelial markers and Quality of life in
      patients with chronic kidney disease undergoing hemodialysis. According to the Investigators,
      this topic was proposed since it is known that several pulmonary complications occur as a
      consequence of chronic kidney disease due to uremic myopathy. Therefore, the hypothesis is
      that the application of a respiratory muscle training protocol will contribute positively
      pulmonary functionality and a decrease in oxidative stress and inflammation in chronic kidney
      patients, consequently, will bring improvement in the quality of life for these patients. The
      Patients will be divided into two groups: control group - No intervention of the Muscular
      Training (CG) And Intervention Group (GI). The intervention protocol will be composed of
      respiratory muscle training And lasts for two (2) months, with three (3) visits per week. It
      will be carried out through Threshold PeP appliance. The twelve (12) first training sessions
      will have a total duration of 30 minutes 15 minutes with inspiratory load of 20 cmH2O and 15
      minutes with expiratory load of 20 CmH 2 O; and the others (12) twelve sessions will last 40
      minutes each, with 20 minutes with an inspiratory load of 20 CmH2O and 20 minutes with
      expiratory load of 20 cmH2O. The variables evaluated will be: muscular strength Respiratory
      (maximum inspiratory pressure and maximum expiratory pressure - Pimáx and Pemáx); Lung
      function (Slow Vital Capacity - CVL, forced expiratory volume in the first minute - VEF1,
      Vital Capacity Forced - CVF and Maximum Voluntary Ventilation - VVM); Serum levels of
      oxidative stress markers, endothelial markers and endothelin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: endothelium glycocalyx biomarkers
time frame: 8 weeks
description: plasma syndecan-1 (ng/mL)
measure: Endothelium biomarker
time frame: 8 weeks
description: ICAM (ng/mL)
measure: Endotehlium Biomarker
time frame: 8 weeks
description: VCAM(ng/mL)
measure: Aberrant angiogenesis
time frame: 8 weeks
description: Angiopoietin-2 (ng/mL)
measure: Oxidative stress
time frame: 8 weeks
description: Plasma Malondialdehyde (mmol/L)
measure: Mean blood pressure
time frame: 8 weeks
description: Blood pressure (mmHg)
arm group label: treatment
arm group type: Experimental
description: Muscle respiratory training
arm group label: control
arm group type: No Intervention
description: No intervention
intervention type: Behavioral
intervention name: Muscle respiratory training
description: Muscle respiratory training during hemodialysis sessions
arm group label: treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Alexandre Liborio, PHD
role: Principal Investigator
affiliation: Universidade Federal do Ceara
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Ceara
investigator full name: Alexandre Braga Liborio
investigator title: Visitant Professor
mesh term: Renal Insufficiency
sharing ipd: No