<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/NCT02249260</url>
  </required_header>
  <id_info>
    <org_study_id>2011/553 (REK)</org_study_id>
    <nct_id>NCT02249260</nct_id>
  </id_info>
  <brief_title>A Prospective Cohort Study of Heart Patients Included in Exercise Based Rehabilitation in Oslo</brief_title>
  <acronym>OsloHeartEx</acronym>
  <official_title>Long-term Follow up of Exercise Based Cardiac Rehabilitation in Oslo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of&#xD;
      this study is to examine factors who predict long-term effects of improved peak oxygen uptake&#xD;
      one year after participating in cardiac rehabilitation.&#xD;
&#xD;
      Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac&#xD;
      rehabilitation program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective cohort study including all cardiac patients referred for outpatient cardiac&#xD;
      rehabilitation in a primary care clinic in Oslo. The main efficacy variable is the changes in&#xD;
      exercise capacity (VO2peak) as a primary prognostic measure of successful rehabilitation.&#xD;
      HRQoL are measured by self-report using the COOP/WONCA questionnaire and SF-36.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in peak oxygen uptake</measure>
    <time_frame>baseline, 15 months</time_frame>
    <description>Change from baseline in peak oxygen uptake at 15 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Changes from baseline in quality of life (COOP/WONCA and SF-36) at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak oxygen uptake</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Change from baseline in peak oxygen uptake at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to exhaustion</measure>
    <time_frame>baseline, 15 months</time_frame>
    <description>Change from baseline in &quot;time to exhaustion&quot; at 15 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to exhaustion</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Change from baseline in time to exhaustion at 12 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Systolic and diastolic Blood Pressure</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Changes from baseline in systolic and diastolic blood pressure at 12 weeks</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Cardiac Disease</condition>
  <arm_group>
    <arm_group_label>Behavioral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group-based high intensity interval training and lifestyle counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intensity interval training</intervention_name>
    <description>Group-based high-intensity aerobic interval training and lifestyle counseling</description>
    <arm_group_label>Behavioral</arm_group_label>
    <other_name>The Norwegian Ullevaal model</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable coronary heart disease&#xD;
&#xD;
          -  valvular surgery&#xD;
&#xD;
          -  refered to high-intensity exercise training from a cardiologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute myocardial infarction within four week&#xD;
&#xD;
          -  serious rhythm disturbances&#xD;
&#xD;
          -  unstable angina pectoris&#xD;
&#xD;
          -  known significant comorbidity&#xD;
&#xD;
          -  symptomatic peripheral vascular disease&#xD;
&#xD;
          -  obstructive pulmonary disease with forced expiratory vital capacity &lt; 60% of predicted&#xD;
&#xD;
          -  left ventricular ejection fraction &lt; 40%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Birgitta B Nilsson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Birgitta B Nilsson, PhD</last_name>
    <phone>+4793210913</phone>
    <email>b.b.nilsson@medisin.uio.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Helge Grimnes, MsC</last_name>
    <phone>+4723015052</phone>
    <email>helge.grimnes@oslo-universitetssykehus.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Norwegian Sport Clinic (NIMI)</name>
      <address>
        <city>Oslo</city>
        <zip>0805</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Birgitta B Nilsson, PhD</last_name>
      <phone>+47 93210913</phone>
      <email>b.b.nilsson@medisin.uio.no</email>
    </contact>
    <investigator>
      <last_name>Birgitta B Nilsson, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Birgitta Blakstad Nilsson, PhD</investigator_full_name>
    <investigator_title>Postdoc</investigator_title>
  </responsible_party>
  <keyword>Exercise, cardiac rehabilitation, quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</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/NCT02249260
org study id: 2011/553 (REK)
nct id: NCT02249260
lead sponsor: 
collaborator: 
has dmc: Yes
Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of
      this study is to examine factors who predict long-term effects of improved peak oxygen uptake
      one year after participating in cardiac rehabilitation.

      Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac
      rehabilitation program.
A prospective cohort study including all cardiac patients referred for outpatient cardiac
      rehabilitation in a primary care clinic in Oslo. The main efficacy variable is the changes in
      exercise capacity (VO2peak) as a primary prognostic measure of successful rehabilitation.
      HRQoL are measured by self-report using the COOP/WONCA questionnaire and SF-36.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in peak oxygen uptake
time frame: baseline, 15 months
description: Change from baseline in peak oxygen uptake at 15 months
measure: Health related quality of life
time frame: baseline, 12 weeks
description: Changes from baseline in quality of life (COOP/WONCA and SF-36) at 12 weeks
measure: Peak oxygen uptake
time frame: baseline, 12 weeks
description: Change from baseline in peak oxygen uptake at 12 weeks
measure: Time to exhaustion
time frame: baseline, 15 months
description: Change from baseline in "time to exhaustion" at 15 months
measure: Time to exhaustion
time frame: baseline, 12 weeks
description: Change from baseline in time to exhaustion at 12 weeks
measure: Systolic and diastolic Blood Pressure
time frame: baseline, 12 weeks
description: Changes from baseline in systolic and diastolic blood pressure at 12 weeks
arm group label: Behavioral
arm group type: Experimental
description: Group-based high intensity interval training and lifestyle counseling
intervention type: Behavioral
intervention name: High intensity interval training
description: Group-based high-intensity aerobic interval training and lifestyle counseling
arm group label: Behavioral
other name: The Norwegian Ullevaal model
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Birgitta B Nilsson, PhD
role: Principal Investigator
affiliation: Oslo University Hospital
last name: Birgitta B Nilsson, PhD
phone: +4793210913
email: b.b.nilsson@medisin.uio.no
last name: Helge Grimnes, MsC
phone: +4723015052
email: helge.grimnes@oslo-universitetssykehus.no
facility: 
status: Recruiting
contact: 
investigator: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Birgitta Blakstad Nilsson, PhD
investigator title: Postdoc
mesh term: Heart Diseases