<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/NCT02219451</url>
  </required_header>
  <id_info>
    <org_study_id>sympathetic modulation</org_study_id>
    <nct_id>NCT02219451</nct_id>
  </id_info>
  <brief_title>Exercise Improve Sympathetic Modulation in Chronic Heart Failure Patients</brief_title>
  <official_title>Exercise Training Improves Oscillatory Pattern and Arterial Baroreflex Control of Sympathetic Nerve Activity in Patients With Chronic Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>InCor Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the effects of exercise training on sympathetic&#xD;
      modulation and arterial baroreflex control in patients with chronic heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective study. Patients were recruited by database from Rehabilitation Unit of&#xD;
      Cardiovascular Rehabilitation and Exercise Physiology of the Heart Institute (InCor). The aim&#xD;
      of this study is to assess the effects of exercise training on sympathetic modulation and&#xD;
      arterial baroreflex control in patients with chronic heart failure. The investigators studied&#xD;
      twenty-six chronic heart failure outpatients, age 30 to 70 years, functional class II to III&#xD;
      of New York Heart Association, left ventricular ejection fraction (LVEF) ≤40% and peak oxygen&#xD;
      uptake (VO2) ≤20. The exclusion criteria were recent myocardial infarction or unstable angina&#xD;
      (&lt;3 months), heart failure duration (&lt;3 months), permanent pacemaker dependence, atrial&#xD;
      fibrillation, skeletal muscle abnormality (e.g., arthritis) and participation in a regular&#xD;
      exercise program. They were assigned to 2 groups: Untrained (n=13) and trained (n=13).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Autonomic control</measure>
    <time_frame>4 months</time_frame>
    <description>To asses the effects of exercise training on sympathetic modulation by analyze of autonomic control in chronic heart failure patients after 4 months protocol.Time series of muscle sympathetic nerve activity and systolic arterial pressure were analyzed by autoregressive spectral analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial baroreflex control</measure>
    <time_frame>4 months</time_frame>
    <description>To asses the effects of exercise training on arterial baroreflex by analyze of arterial baroreflex control in chronic heart failure patients after 4 months. The arterial baroreflex control was analyzed by bivariate autoregressive.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We studied twenty-six chronic heart failure outpatients and they were assigned to 2 groups: Untrained (n=13) and trained (n=13).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise training</intervention_name>
    <description>exercise training</description>
    <arm_group_label>exercise training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic heart failure&#xD;
&#xD;
          -  Age 30 to 70 years&#xD;
&#xD;
          -  Functional class II to III of New York Heart Association&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) ≤40%&#xD;
&#xD;
          -  Peak oxygen uptake (VO2) ≤20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent myocardial infarction or unstable angina (&lt;3 months)&#xD;
&#xD;
          -  heart failure duration (&lt;3 months)&#xD;
&#xD;
          -  Permanent pacemaker dependence&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Skeletal muscle abnormality (e.g., arthritis)&#xD;
&#xD;
          -  Participation in a regular exercise program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heart Institute HC/FMUSP, HC/FMUSP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart Institute, University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto do Coração - HC/FMUSP</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Raphaela Vilar Ramalho Groehs</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <keyword>Chronic heart failure</keyword>
  <keyword>exercise training</keyword>
  <keyword>Sympathetic modulation</keyword>
  <keyword>arterial baroreflex control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT02219451
org study id: sympathetic modulation
nct id: NCT02219451
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to verify the effects of exercise training on sympathetic
      modulation and arterial baroreflex control in patients with chronic heart failure.
Retrospective study. Patients were recruited by database from Rehabilitation Unit of
      Cardiovascular Rehabilitation and Exercise Physiology of the Heart Institute (InCor). The aim
      of this study is to assess the effects of exercise training on sympathetic modulation and
      arterial baroreflex control in patients with chronic heart failure. The investigators studied
      twenty-six chronic heart failure outpatients, age 30 to 70 years, functional class II to III
      of New York Heart Association, left ventricular ejection fraction (LVEF) ≤40% and peak oxygen
      uptake (VO2) ≤20. The exclusion criteria were recent myocardial infarction or unstable angina
      (<3 months), heart failure duration (<3 months), permanent pacemaker dependence, atrial
      fibrillation, skeletal muscle abnormality (e.g., arthritis) and participation in a regular
      exercise program. They were assigned to 2 groups: Untrained (n=13) and trained (n=13).
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Participant)
measure: Autonomic control
time frame: 4 months
description: To asses the effects of exercise training on sympathetic modulation by analyze of autonomic control in chronic heart failure patients after 4 months protocol.Time series of muscle sympathetic nerve activity and systolic arterial pressure were analyzed by autoregressive spectral analysis
measure: Arterial baroreflex control
time frame: 4 months
description: To asses the effects of exercise training on arterial baroreflex by analyze of arterial baroreflex control in chronic heart failure patients after 4 months. The arterial baroreflex control was analyzed by bivariate autoregressive.
arm group label: exercise training
arm group type: Experimental
description: We studied twenty-six chronic heart failure outpatients and they were assigned to 2 groups: Untrained (n=13) and trained (n=13).
intervention type: Other
intervention name: exercise training
description: exercise training
arm group label: exercise training
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Heart Institute HC/FMUSP, HC/FMUSP
role: Principal Investigator
affiliation: Heart Institute, University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Raphaela Vilar Ramalho Groehs
investigator title: PhD student
mesh term: Heart Failure