<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/NCT02235753</url>
  </required_header>
  <id_info>
    <org_study_id>1072011</org_study_id>
    <nct_id>NCT02235753</nct_id>
  </id_info>
  <brief_title>High-intensity Exercise After Acute Cardiac Event (HITCARE)</brief_title>
  <acronym>HITCARE</acronym>
  <official_title>High-Intensity Exercise Training in Cardiac Rehabilitation After Acute Coronary Event - Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuopio Research Institute of Exercise Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Social Insurance Institution, Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Eastern Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kuopio Research Institute of Exercise Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the well-known health benefits of physical exercise in the prevention of chronic&#xD;
      diseases, less attention has been focused on the use of physical exercise as an essential&#xD;
      part of good treatment for chronic disease. The aims of the study are to investigate the&#xD;
      feasibility, medical effects, cost-effectiveness, and social perspectives of the&#xD;
      individualized exercise-based rehabilitation [2 different high-intensity training (HIT)&#xD;
      protocols combined with usual care (UC)] after acute coronary artery disease (CAD) event. The&#xD;
      medical aim is to study mediating mechanisms of the physiological, biochemical and molecular&#xD;
      effects of exercise training on the clinical outcomes. The aim of the health-economic&#xD;
      evaluation is to assess the changes in the Health-Related Quality of Life (HRQL) and health&#xD;
      care related costs for estimating the cost-effectiveness of HIT-based exercise&#xD;
      rehabilitation. The purpose of the sociological analysis is to find out the social processes&#xD;
      which make possible the emergence of the desired welfare effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population consists of patients living in the city of Kuopio or Siilinjarvi area in&#xD;
      Eastern Finland, who have been treated in Kuopio University Hospital because of acute CAD&#xD;
      event. After baseline measurements, the patients will be randomized into one of the 3 groups:&#xD;
      short interval HIT protocol (HIT-S), long interval HIT protocol (HIT-L) or UC group. The&#xD;
      intervention will be 12 months per patient and the expected duration of the whole study&#xD;
      (intervention data collection) is estimated to be 4 years. In addition, all groups will have&#xD;
      annual follow-up examinations scheduled up to 60 months after initiation of the intervention&#xD;
      phase. The patients recruited for the study will be 750, a total of 250 patients per study&#xD;
      group.&#xD;
&#xD;
      All measurements related to intervention will be performed at Kuopio Research Institute of&#xD;
      Exercise Medicine. Examinations concerning myocardial structure and perfusion will be done at&#xD;
      Turku PET Center (subsample).&#xD;
&#xD;
      The study complies with the Helsinki declaration, follows good clinical practice. Patient&#xD;
      safety will follow normal medical practice. The intervention is not anticipated to cause&#xD;
      health risks apart from the conventional treatment. All participants will be provided with&#xD;
      diverse individualized information about their health and physical performance. The research&#xD;
      methods employed in the study are safe. Physician and nurse will be present at each occasion&#xD;
      when physically strenuous measurements are performed and careful provisions for appropriate&#xD;
      first aid will be made. The measurements assessing cardiorespiratory and muscular fitness&#xD;
      will involve hard effort and it is not unusual to feel innocent muscle pain for a few days&#xD;
      after measurements demanding maximal effort. The other potential acute complications may&#xD;
      include accidents (e.g. injuries due to slipping or falling) and medical emergencies like&#xD;
      acute myocardial infarction.&#xD;
&#xD;
      Study hypotheses:&#xD;
&#xD;
        1. Short (15 sec) and long interval (3 min) high-intensity aerobic interval training (HIT)&#xD;
           combined with resistance training after acute CAD event are equally effective in&#xD;
           improving cardiorespiratory fitness compared with UC.&#xD;
&#xD;
        2. Despite higher unit costs, the differences in health-related quality of life effects are&#xD;
           so large that both HIT interventions are cost-effective compared with UC.&#xD;
&#xD;
        3. Patient's experiences and interpretation of HIT exercise as well as different social&#xD;
           processes during rehabilitation explain the cost-effectiveness of the rehabilitation.&#xD;
&#xD;
        4. Patient groups who will or will not benefit of HIT interventions can be identified and&#xD;
           predicted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment was stopped due to lack of funding.&#xD;
  </why_stopped>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Actual">November 14, 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak)</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incremental health care cost/quality-adjusted life-year-relation</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social processes explaining adherence and motivation to exercise rehabilitation</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
    <description>Social analysis will be performed by specific questionnaires and interviews. Subjective perceptions on the social mechanisms impacting on health and well-being as a part of the rehabilitation processes will be also be modelled using comparative causal mapping techniques (CMT) (See http://www.uef.fi/fi/cmap3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total costs of the use of health care services</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
    <description>The use of total health services will be assessed by diary, questionnaire and from registers (national, hospital district and domicile health center).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utilization of health care resources</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health-related quality of life</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in ergospirometer variables</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in muscular performance</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in daily energy expenditure</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Sleeping time</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Sitting time</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Dietary habits</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
    <description>Measured by food frequency questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in chest pain symptoms, exercise induced angina or ischemia</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
    <description>Composite measure based on anamnesis and ECG</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in antianginal and other medication</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospitalization due to cardiovascular causes</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in vascular risk factors</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Progression of peripheral atherosclerosis</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in cognitive function</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in depressive symptoms</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intervention related adverse events</measure>
    <time_frame>Throughout the intervention phase</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in myocardial blood flow capacity and left ventricular function</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in myocardial blood flow at rest and during adenosine infusion</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in myocardial blood flow reserve</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in left ventricular ejection fraction</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in left ventricular longitudinal peak systolic strain</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in left mitral annular diastolic tissue velocity</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in autonomic nervous system control of cardiac function</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in body composition</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
    <description>Measured by bioimpedance</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in anthropometric measures</measure>
    <time_frame>Baseline, 6 and 12 months</time_frame>
    <description>Measured by body weight, body height, waist circumference, and hip circumference.&#xD;
Body mass index and waist to hip ratio will be calculated.</description>
  </other_outcome>
  <other_outcome>
    <measure>All-cause death</measure>
    <time_frame>Baseline, 6 and 12 months; annual follow-up up to 60 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>Baseline, 6 and 12 months; annual follow-up up to 60 months</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Unstable Angina Pectoris</condition>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Recurrent Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>High-intensity interval training, HIT-S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-intensity aerobic interval training, short interval (HIT-S)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-intensity interval training, HIT-L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-intensity aerobic interval training, long interval (HIT-L)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High-intensity aerobic interval training, short interval</intervention_name>
    <description>The intensity of HIT-S sessions (cycle ergometer) will be increased during 3 to 6 months from 60% of VO2peak to 100% which will be the target intensity from 6 to 12 months. The protocol includes four 6 min sets consisting of 15 sec exercise followed by 15 sec passive recovery separated with 3 min passive recovery between sets. Exercise session will last ca. 40 min, with 12 min of HIT, warm-up and recovery. The intensity of the 15 seconds exercise bouts will be based on VO2peak at baseline and after 6 months. Meanwhile, the estimated VO2peak from the submaximal test will be used to adjust the training intensity in HIT sessions. Training will be conducted in a group of 1-3 HIT-S patients with ECG monitoring and supervised by physician.</description>
    <arm_group_label>High-intensity interval training, HIT-S</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High-intensity aerobic interval training, long interval</intervention_name>
    <description>The intensity of HIT-L sessions (cycle ergometer) will be increased during 3 to 6 months from 60% of VO2peak to 90% which will be the target intensity from 6 to 12 months. The protocol includes four 3 min exercise bouts with a 4 min recovery (pedaling at 0 W) between bouts. Exercise session will last ca. 40 min, with 12 min of HIT, warm-up and recovery. The intensity of the 3 min exercise bouts will be based on VO2peak at baseline and after 6 months. Meanwhile, the estimated VO2peak from the submaximal test will be used to adjust the training intensity in HIT sessions. Training will be conducted in a group of 1-3 HIT-L patients with ECG monitoring and supervised by physician.</description>
    <arm_group_label>High-intensity interval training, HIT-L</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hospital care after acute CAD event (ICD-10 codes I20.0-I22)&#xD;
&#xD;
          -  age 40-80 years&#xD;
&#xD;
          -  signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  conditions preventing regular exercise training&#xD;
&#xD;
          -  severe/malignant disease (life expectancy &lt;12 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rainer Rauramaa, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kuopio Research Institute of Exercise Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kuopio Research Institute of Exercise Medicine</name>
      <address>
        <city>Kuopio</city>
        <zip>70100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kuopio Research Institute of Exercise Medicine</investigator_affiliation>
    <investigator_full_name>Rainer Rauramaa</investigator_full_name>
    <investigator_title>Professor</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>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Unstable</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/NCT02235753
org study id: 1072011
nct id: NCT02235753
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Despite the well-known health benefits of physical exercise in the prevention of chronic
      diseases, less attention has been focused on the use of physical exercise as an essential
      part of good treatment for chronic disease. The aims of the study are to investigate the
      feasibility, medical effects, cost-effectiveness, and social perspectives of the
      individualized exercise-based rehabilitation [2 different high-intensity training (HIT)
      protocols combined with usual care (UC)] after acute coronary artery disease (CAD) event. The
      medical aim is to study mediating mechanisms of the physiological, biochemical and molecular
      effects of exercise training on the clinical outcomes. The aim of the health-economic
      evaluation is to assess the changes in the Health-Related Quality of Life (HRQL) and health
      care related costs for estimating the cost-effectiveness of HIT-based exercise
      rehabilitation. The purpose of the sociological analysis is to find out the social processes
      which make possible the emergence of the desired welfare effects.
The study population consists of patients living in the city of Kuopio or Siilinjarvi area in
      Eastern Finland, who have been treated in Kuopio University Hospital because of acute CAD
      event. After baseline measurements, the patients will be randomized into one of the 3 groups:
      short interval HIT protocol (HIT-S), long interval HIT protocol (HIT-L) or UC group. The
      intervention will be 12 months per patient and the expected duration of the whole study
      (intervention data collection) is estimated to be 4 years. In addition, all groups will have
      annual follow-up examinations scheduled up to 60 months after initiation of the intervention
      phase. The patients recruited for the study will be 750, a total of 250 patients per study
      group.

      All measurements related to intervention will be performed at Kuopio Research Institute of
      Exercise Medicine. Examinations concerning myocardial structure and perfusion will be done at
      Turku PET Center (subsample).

      The study complies with the Helsinki declaration, follows good clinical practice. Patient
      safety will follow normal medical practice. The intervention is not anticipated to cause
      health risks apart from the conventional treatment. All participants will be provided with
      diverse individualized information about their health and physical performance. The research
      methods employed in the study are safe. Physician and nurse will be present at each occasion
      when physically strenuous measurements are performed and careful provisions for appropriate
      first aid will be made. The measurements assessing cardiorespiratory and muscular fitness
      will involve hard effort and it is not unusual to feel innocent muscle pain for a few days
      after measurements demanding maximal effort. The other potential acute complications may
      include accidents (e.g. injuries due to slipping or falling) and medical emergencies like
      acute myocardial infarction.

      Study hypotheses:

        1. Short (15 sec) and long interval (3 min) high-intensity aerobic interval training (HIT)
           combined with resistance training after acute CAD event are equally effective in
           improving cardiorespiratory fitness compared with UC.

        2. Despite higher unit costs, the differences in health-related quality of life effects are
           so large that both HIT interventions are cost-effective compared with UC.

        3. Patient's experiences and interpretation of HIT exercise as well as different social
           processes during rehabilitation explain the cost-effectiveness of the rehabilitation.

        4. Patient groups who will or will not benefit of HIT interventions can be identified and
           predicted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak)
time frame: Baseline, 6 and 12 months
measure: Incremental health care cost/quality-adjusted life-year-relation
time frame: Baseline, 6 and 12 months
measure: Social processes explaining adherence and motivation to exercise rehabilitation
time frame: Baseline, 6 and 12 months
description: Social analysis will be performed by specific questionnaires and interviews. Subjective perceptions on the social mechanisms impacting on health and well-being as a part of the rehabilitation processes will be also be modelled using comparative causal mapping techniques (CMT) (See http://www.uef.fi/fi/cmap3).
measure: Total costs of the use of health care services
time frame: Baseline, 6 and 12 months
description: The use of total health services will be assessed by diary, questionnaire and from registers (national, hospital district and domicile health center).
measure: Utilization of health care resources
time frame: Baseline, 6 and 12 months
measure: Change in health-related quality of life
time frame: Baseline, 6 and 12 months
measure: Change in ergospirometer variables
time frame: Baseline, 6 and 12 months
measure: Change in muscular performance
time frame: Baseline, 6 and 12 months
measure: Change in daily energy expenditure
time frame: Baseline, 6 and 12 months
measure: Sleeping time
time frame: Baseline, 6 and 12 months
measure: Sitting time
time frame: Baseline, 6 and 12 months
measure: Dietary habits
time frame: Baseline, 6 and 12 months
description: Measured by food frequency questionnaire
measure: Change in chest pain symptoms, exercise induced angina or ischemia
time frame: Baseline, 6 and 12 months
description: Composite measure based on anamnesis and ECG
measure: Change in antianginal and other medication
time frame: Baseline, 6 and 12 months
measure: Hospitalization due to cardiovascular causes
time frame: Baseline, 6 and 12 months
measure: Change in vascular risk factors
time frame: Baseline, 6 and 12 months
measure: Progression of peripheral atherosclerosis
time frame: Baseline, 6 and 12 months
measure: Change in cognitive function
time frame: Baseline and 12 months
measure: Change in depressive symptoms
time frame: Baseline, 6 and 12 months
measure: Intervention related adverse events
time frame: Throughout the intervention phase
measure: Change in myocardial blood flow capacity and left ventricular function
time frame: Baseline and 12 months
measure: Change in myocardial blood flow at rest and during adenosine infusion
time frame: Baseline and 12 months
measure: Change in myocardial blood flow reserve
time frame: Baseline and 12 months
measure: Change in left ventricular ejection fraction
time frame: Baseline and 12 months
measure: Change in left ventricular longitudinal peak systolic strain
time frame: Baseline and 12 months
measure: Change in left mitral annular diastolic tissue velocity
time frame: Baseline and 12 months
measure: Change in autonomic nervous system control of cardiac function
time frame: Baseline and 12 months
measure: Change in body composition
time frame: Baseline, 6 and 12 months
description: Measured by bioimpedance
measure: Change in anthropometric measures
time frame: Baseline, 6 and 12 months
description: Measured by body weight, body height, waist circumference, and hip circumference.
Body mass index and waist to hip ratio will be calculated.
measure: All-cause death
time frame: Baseline, 6 and 12 months; annual follow-up up to 60 months
measure: Cardiovascular death
time frame: Baseline, 6 and 12 months; annual follow-up up to 60 months
arm group label: High-intensity interval training, HIT-S
arm group type: Experimental
description: High-intensity aerobic interval training, short interval (HIT-S)
arm group label: High-intensity interval training, HIT-L
arm group type: Experimental
description: High-intensity aerobic interval training, long interval (HIT-L)
arm group label: Usual care
arm group type: No Intervention
description: control group
intervention type: Behavioral
intervention name: High-intensity aerobic interval training, short interval
description: The intensity of HIT-S sessions (cycle ergometer) will be increased during 3 to 6 months from 60% of VO2peak to 100% which will be the target intensity from 6 to 12 months. The protocol includes four 6 min sets consisting of 15 sec exercise followed by 15 sec passive recovery separated with 3 min passive recovery between sets. Exercise session will last ca. 40 min, with 12 min of HIT, warm-up and recovery. The intensity of the 15 seconds exercise bouts will be based on VO2peak at baseline and after 6 months. Meanwhile, the estimated VO2peak from the submaximal test will be used to adjust the training intensity in HIT sessions. Training will be conducted in a group of 1-3 HIT-S patients with ECG monitoring and supervised by physician.
arm group label: High-intensity interval training, HIT-S
intervention type: Behavioral
intervention name: High-intensity aerobic interval training, long interval
description: The intensity of HIT-L sessions (cycle ergometer) will be increased during 3 to 6 months from 60% of VO2peak to 90% which will be the target intensity from 6 to 12 months. The protocol includes four 3 min exercise bouts with a 4 min recovery (pedaling at 0 W) between bouts. Exercise session will last ca. 40 min, with 12 min of HIT, warm-up and recovery. The intensity of the 3 min exercise bouts will be based on VO2peak at baseline and after 6 months. Meanwhile, the estimated VO2peak from the submaximal test will be used to adjust the training intensity in HIT sessions. Training will be conducted in a group of 1-3 HIT-L patients with ECG monitoring and supervised by physician.
arm group label: High-intensity interval training, HIT-L
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rainer Rauramaa, professor
role: Principal Investigator
affiliation: Kuopio Research Institute of Exercise Medicine
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Kuopio Research Institute of Exercise Medicine
investigator full name: Rainer Rauramaa
investigator title: Professor
mesh term: Myocardial Infarction
mesh term: Angina Pectoris
mesh term: Angina, Unstable
mesh term: Infarction