<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/NCT03034980</url>
  </required_header>
  <id_info>
    <org_study_id>PD-VG-01</org_study_id>
    <nct_id>NCT03034980</nct_id>
  </id_info>
  <brief_title>Influence of Training Intensity in Coronary Artery Disease</brief_title>
  <official_title>Influence of Training Intensity on Exercise Capacity and Risk Profile in Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</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>
      Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the&#xD;
      coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are&#xD;
      often treated with percutaneous coronary intervention (PCI) or coronary artery bypass&#xD;
      grafting (CABG). Following hospitalisation, the patients are offered to attend a classical&#xD;
      rehabilitation program with moderate exercise intensity. Current exercise program for cardiac&#xD;
      rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve&#xD;
      the exercise capacity and risk profile even more if the exercise program includes more&#xD;
      vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG)&#xD;
      and takes 12 weeks to complete. Patients with heart failure and valvular disease are&#xD;
      excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are&#xD;
      determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the&#xD;
      aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training&#xD;
      load during rehabilitation.&#xD;
&#xD;
      The research goal is to investigate the influence of training intensity on the exercise&#xD;
      capacity and risk profile of CAD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>exercise capacity</measure>
    <time_frame>up to week 12</time_frame>
    <description>The primary endpoint is the relationship between the actual training load (W) and exercise capacity (VO2max) obtained at the end of the rehabilitation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardiovascular risk profile</measure>
    <time_frame>up to week 12</time_frame>
    <description>The secondary endpoint is the relationship between relative training load and the cardiovascular risk factors.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">343</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Coronary Artery Disease (CAD) patients</arm_group_label>
    <description>Patients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training intensity (workload) during ergospirometry</intervention_name>
    <description>The reached workload (W) during each training is noted during 12 weeks of rehabilitation. The relative intensity is expressed as a percentage of VT1 and VT2.</description>
    <arm_group_label>Coronary Artery Disease (CAD) patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with proven coronary artery disease, who underwent the full cardiac revalidation&#xD;
        program at Jessa Hospital from 10-1-2013 till 12-9-2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute myocardial infarction (AMI), who underwent a percutaneous coronary&#xD;
             intervention (PCI) or coronary artery bypass grafting (CABG). The 12-week program must&#xD;
             be completed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with heart failure (HFpEF and HFrEF with ejection fraction ≤40%) and valvular&#xD;
             heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaatje Goetschalckx, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Catholic University Leuven, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>February 26, 2018</last_update_submitted>
  <last_update_submitted_qc>February 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>prof. dr. Paul Dendale</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</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/NCT03034980
org study id: PD-VG-01
nct id: NCT03034980
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the
      coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are
      often treated with percutaneous coronary intervention (PCI) or coronary artery bypass
      grafting (CABG). Following hospitalisation, the patients are offered to attend a classical
      rehabilitation program with moderate exercise intensity. Current exercise program for cardiac
      rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve
      the exercise capacity and risk profile even more if the exercise program includes more
      vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG)
      and takes 12 weeks to complete. Patients with heart failure and valvular disease are
      excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are
      determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the
      aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training
      load during rehabilitation.

      The research goal is to investigate the influence of training intensity on the exercise
      capacity and risk profile of CAD patients.
observational model: Case-Control
time perspective: Retrospective
measure: exercise capacity
time frame: up to week 12
description: The primary endpoint is the relationship between the actual training load (W) and exercise capacity (VO2max) obtained at the end of the rehabilitation.
measure: cardiovascular risk profile
time frame: up to week 12
description: The secondary endpoint is the relationship between relative training load and the cardiovascular risk factors.
arm group label: Coronary Artery Disease (CAD) patients
description: Patients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016.
intervention type: Other
intervention name: Training intensity (workload) during ergospirometry
description: The reached workload (W) during each training is noted during 12 weeks of rehabilitation. The relative intensity is expressed as a percentage of VT1 and VT2.
arm group label: Coronary Artery Disease (CAD) patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 90 Years
healthy volunteers: No
last name: Kaatje Goetschalckx, MD
role: Principal Investigator
affiliation: Catholic University Leuven, Belgium
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: prof. dr. Paul Dendale
investigator title: prof. dr.
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No