<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/NCT02224495</url>
  </required_header>
  <id_info>
    <org_study_id>ET2011</org_study_id>
    <nct_id>NCT02224495</nct_id>
  </id_info>
  <brief_title>The Effect of Exercise Training on Cardiac Structure and Function</brief_title>
  <official_title>The Effect of Exercise Training on Cardiac Structure and Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gaia Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade do Porto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gaia Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exercise training, as part of cardiac rehabilitation, is effective in improving functional&#xD;
      capacity and quality of life in patients with coronary artery disease. Other cardiovascular&#xD;
      and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal&#xD;
      muscle function, oxidative stress, vascular function, pulmonary circulation,&#xD;
      ischaemia-reperfusion lesion and ventricular remodelling.&#xD;
&#xD;
      However, the benefit of exercise training on systolic and diastolic function is controversial&#xD;
      especially after acute myocardial infarction where no longitudinal study has evaluated&#xD;
      diastolic function using modern echocardiographic parameters.&#xD;
&#xD;
      The hypothesis is that a structured program of exercise training can improve systolic and&#xD;
      diastolic function in patients after myocardial infarction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)</measure>
    <time_frame>4 months</time_frame>
    <description>Determined by echocardiography; results in cm/s</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)</measure>
    <time_frame>4 months</time_frame>
    <description>Determined by echocardiography; no unit (ratio)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)</measure>
    <time_frame>4 months</time_frame>
    <description>Determined by echocardiography; results in cm/s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left ventriclular ejection fraction</measure>
    <time_frame>4 months</time_frame>
    <description>Determined by echocardiography; results in %</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Structured exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured exercise training</intervention_name>
    <arm_group_label>Structured exercise training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients one month after myocardial infarction&#xD;
&#xD;
          -  Older 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age above 75 years,&#xD;
&#xD;
          -  Inability to exercise,&#xD;
&#xD;
          -  Hemodinamically significant valvular disease,&#xD;
&#xD;
          -  Moderate to severe chronic lung disease (vital capacity and/or forced expiratory&#xD;
             volume in 1 s &lt;80% of age-dependent predicted value),&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Exercise induced myocardial ischemia&#xD;
&#xD;
          -  Anaemia (haemoglobin &lt;12 g/dl).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adelino Leite-Moreira, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade do Porto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiology Department Gaia Hospital Center</name>
      <address>
        <city>Gaia</city>
        <zip>4450-189</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gaia Hospital</investigator_affiliation>
    <investigator_full_name>Ricardo Fontes Carvalho</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT02224495
org study id: ET2011
nct id: NCT02224495
lead sponsor: 
collaborator: 
has dmc: No
Exercise training, as part of cardiac rehabilitation, is effective in improving functional
      capacity and quality of life in patients with coronary artery disease. Other cardiovascular
      and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal
      muscle function, oxidative stress, vascular function, pulmonary circulation,
      ischaemia-reperfusion lesion and ventricular remodelling.

      However, the benefit of exercise training on systolic and diastolic function is controversial
      especially after acute myocardial infarction where no longitudinal study has evaluated
      diastolic function using modern echocardiographic parameters.

      The hypothesis is that a structured program of exercise training can improve systolic and
      diastolic function in patients after myocardial infarction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)
time frame: 4 months
description: Determined by echocardiography; results in cm/s
measure: Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)
time frame: 4 months
description: Determined by echocardiography; no unit (ratio)
measure: Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)
time frame: 4 months
description: Determined by echocardiography; results in cm/s
measure: Left ventriclular ejection fraction
time frame: 4 months
description: Determined by echocardiography; results in %
arm group label: Control
arm group type: Placebo Comparator
description: Standard of care
arm group label: Structured exercise training
arm group type: Experimental
description: 8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training
intervention type: Behavioral
intervention name: Structured exercise training
arm group label: Structured exercise training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Adelino Leite-Moreira, PhD
role: Study Director
affiliation: Universidade do Porto
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Gaia Hospital
investigator full name: Ricardo Fontes Carvalho
investigator title: MD, PhD
mesh term: Myocardial Infarction
mesh term: Infarction