<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/NCT02228603</url>
  </required_header>
  <id_info>
    <org_study_id>2014/92</org_study_id>
    <nct_id>NCT02228603</nct_id>
  </id_info>
  <brief_title>Exercise as a Life-long Medicine in Patients With Coronary Artery Disease</brief_title>
  <official_title>How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Nord-Trøndelag HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</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>
      Exercise training is a core component in cardiac rehabilitation. Exercise adherence is,&#xD;
      however, low after rehabilitation and the transition from supervised to unsupervised exercise&#xD;
      is problematic for many patients with coronary artery disease. Therefore, it is important to&#xD;
      provide extended services to improve exercise adherence and healthy lifestyle changes.&#xD;
&#xD;
      The aim of this study is to assess the effect of a time-limited intervention following&#xD;
      out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in peak oxygen uptake</measure>
    <time_frame>2 years</time_frame>
    <description>measured during exercise on treadmill (MetaMax Cortex/Innocor)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>physical activity</measure>
    <time_frame>2 years</time_frame>
    <description>assessed by accelerometer SenseWear Armband Pro</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>assessed by MacNew Health-related quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>depression</measure>
    <time_frame>2 years</time_frame>
    <description>assessed by Hospital anxiety and depression scale (HAD)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Angina (Stable)</condition>
  <arm_group>
    <arm_group_label>high-intensity exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>web-based follow-up</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>web-based follow-up program: home-based group will be followed up by mail and telephone calls the first 8 weeks, then every third month for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>control group will receive usual care: information about recommended physical activity and healthy lifestyle</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>high-intensity exercise training</intervention_name>
    <arm_group_label>high-intensity exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>web-based follow-up program</intervention_name>
    <arm_group_label>web-based follow-up</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>usual care</intervention_name>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  myocardial infarction, stable angina, heart surgery&#xD;
&#xD;
          -  finished phase 2 cardiac rehabilitation&#xD;
&#xD;
          -  clinically stable&#xD;
&#xD;
          -  able to communicate in Norwegian&#xD;
&#xD;
          -  able to do a maximal treadmill test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable angina&#xD;
&#xD;
          -  serious cardiac arrhythmia&#xD;
&#xD;
          -  serious heart valve insufficiency&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  any contraindication for high intensity exercise training&#xD;
&#xD;
          -  participation in other exercise study&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  drug abuse&#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>Asbjørn Støylen, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Levanger Hospital</name>
      <address>
        <city>Levanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise therapy</keyword>
  <keyword>rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <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/NCT02228603
org study id: 2014/92
nct id: NCT02228603
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Exercise training is a core component in cardiac rehabilitation. Exercise adherence is,
      however, low after rehabilitation and the transition from supervised to unsupervised exercise
      is problematic for many patients with coronary artery disease. Therefore, it is important to
      provide extended services to improve exercise adherence and healthy lifestyle changes.

      The aim of this study is to assess the effect of a time-limited intervention following
      out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in peak oxygen uptake
time frame: 2 years
description: measured during exercise on treadmill (MetaMax Cortex/Innocor)
measure: physical activity
time frame: 2 years
description: assessed by accelerometer SenseWear Armband Pro
measure: quality of life
time frame: 2 years
description: assessed by MacNew Health-related quality of life questionnaire
measure: depression
time frame: 2 years
description: assessed by Hospital anxiety and depression scale (HAD)
arm group label: high-intensity exercise
arm group type: Experimental
description: community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months
arm group label: web-based follow-up
arm group type: Active Comparator
description: web-based follow-up program: home-based group will be followed up by mail and telephone calls the first 8 weeks, then every third month for 12 months
arm group label: control
arm group type: Other
description: control group will receive usual care: information about recommended physical activity and healthy lifestyle
intervention type: Behavioral
intervention name: high-intensity exercise training
arm group label: high-intensity exercise
intervention type: Behavioral
intervention name: web-based follow-up program
arm group label: web-based follow-up
intervention type: Behavioral
intervention name: usual care
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Asbjørn Støylen, prof
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
facility: 
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Myocardial Infarction
mesh term: Infarction