<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/NCT01673139</url>
  </required_header>
  <id_info>
    <org_study_id>2012/978b</org_study_id>
    <nct_id>NCT01673139</nct_id>
  </id_info>
  <brief_title>Effect of 3 Years of Exercise in Patients With Atrial Fibrillation</brief_title>
  <official_title>Effect of 3 Years of Exercise in Patients With Atrial Fibrillation - A Generation 100 Substudy</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>SINTEF Health Research</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>
      This is a substudy of &quot;Generation 100&quot;. The investigators will follow the persons with atrial&#xD;
      fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial&#xD;
      fibrillation, symptoms, use of health services or echocardiographic findings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in burden of atrial fibrillation</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Burden of atrial fibrillation; measured by Holter monitor and the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Size of left ventricle</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Echocardiographic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Measured with SF-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Diameter of brachial artery measured by ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal oxygen uptake</measure>
    <time_frame>At baseline and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial extrasystoles</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Measured with Holter monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalisations with atrial fibrillation as main diagnosis</measure>
    <time_frame>Total number during the 3 year intervention period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of electrical cardioversions</measure>
    <time_frame>During the 3 years of intervention</time_frame>
    <description>Number of electrical cardioversions because og atrial fibrillation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in burden of atrial fibrillation</measure>
    <time_frame>Baseline and 1 year</time_frame>
    <description>Measured by Holter and the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of left atrium</measure>
    <time_frame>Baseline and 1 year</time_frame>
    <description>Echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function of left atrium</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Echocardiographic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function of left ventricle</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Echocardiographic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of left atrium</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Echocardiographic measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom burden</measure>
    <time_frame>At baseline and 3 years</time_frame>
    <description>Measured with Symptom and Severity Checklist.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Moderate exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moderate exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interval exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>interval exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interval exercise</intervention_name>
    <description>4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 3 years.</description>
    <arm_group_label>Interval exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Moderate exercise</intervention_name>
    <description>Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.</description>
    <arm_group_label>Moderate exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Given information on recommendations for physical activity.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Included in the &quot;Generation 100 study&quot;&#xD;
&#xD;
          -  Atrial fibrillation diagnosis verified by ECG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Paal Loennechen, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>St. Olavs Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norwegian University of Science and Technology</name>
      <address>
        <city>Trondheim</city>
        <zip>7491</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>November 16, 2018</last_update_submitted>
  <last_update_submitted_qc>November 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</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/NCT01673139
org study id: 2012/978b
nct id: NCT01673139
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a substudy of "Generation 100". The investigators will follow the persons with atrial
      fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial
      fibrillation, symptoms, use of health services or echocardiographic findings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in burden of atrial fibrillation
time frame: At baseline and 3 years
description: Burden of atrial fibrillation; measured by Holter monitor and the patient.
measure: Size of left ventricle
time frame: At baseline and 3 years
description: Echocardiographic measures
measure: Quality of life
time frame: At baseline and 3 years
description: Measured with SF-36
measure: Endothelial function
time frame: At baseline and 3 years
description: Diameter of brachial artery measured by ultrasound.
measure: Maximal oxygen uptake
time frame: At baseline and 3 years
measure: Atrial extrasystoles
time frame: At baseline and 3 years
description: Measured with Holter monitor
measure: Number of hospitalisations with atrial fibrillation as main diagnosis
time frame: Total number during the 3 year intervention period
measure: Total number of electrical cardioversions
time frame: During the 3 years of intervention
description: Number of electrical cardioversions because og atrial fibrillation
measure: Change in burden of atrial fibrillation
time frame: Baseline and 1 year
description: Measured by Holter and the patient.
measure: Size of left atrium
time frame: Baseline and 1 year
description: Echocardiography
measure: Function of left atrium
time frame: At baseline and 3 years
description: Echocardiographic measures
measure: Function of left ventricle
time frame: At baseline and 3 years
description: Echocardiographic measures
measure: Size of left atrium
time frame: At baseline and 3 years
description: Echocardiographic measures
measure: Symptom burden
time frame: At baseline and 3 years
description: Measured with Symptom and Severity Checklist.
arm group label: Moderate exercise
arm group type: Experimental
description: Moderate exercise
arm group label: Control
arm group type: Experimental
description: Control group
arm group label: Interval exercise
arm group type: Experimental
description: interval exercise
intervention type: Behavioral
intervention name: Interval exercise
description: 4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 3 years.
arm group label: Interval exercise
intervention type: Behavioral
intervention name: Moderate exercise
description: Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.
arm group label: Moderate exercise
intervention type: Behavioral
intervention name: Control
description: Given information on recommendations for physical activity.
arm group label: Control
criteria: 
gender: All
minimum age: 70 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jan Paal Loennechen, PhD
role: Study Chair
affiliation: St. Olavs Hospital
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Atrial Fibrillation