<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/NCT01680302</url>
  </required_header>
  <id_info>
    <org_study_id>2012/978b-2</org_study_id>
    <nct_id>NCT01680302</nct_id>
  </id_info>
  <brief_title>Effect of 3 Years of Exercise on Development of Atrial Fibrillation</brief_title>
  <official_title>Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A &quot;Generation 100&quot; 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>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a substudy of &quot;Generation 100&quot;. In that study, 4000 healthy persons between 70 and 75&#xD;
      will be randomised to a moderate intensity training group, a high intensity training group or&#xD;
      control group, with 3 years of exercise. The investigators will follow these persons and&#xD;
      register all who develop atrial fibrillation during these 3 years, and at follow-up after&#xD;
      ended intervention to see if there is differences in the number of persons who develop atrial&#xD;
      fibrillation in the 3 groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Number of persons who develop atrial fibrillation during the 3 year intervention period</measure>
    <time_frame>3 years</time_frame>
    <description>People who already have the diagnosis before randomisation will not be counted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of persons who develop atrial fibrillation during the 6 years after randomisation</measure>
    <time_frame>6 years</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1567</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>High intensity exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High intensity exercise(Borg 16) in intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate intensity exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moderate intensity exercise 3 times a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise on their own. Follow current guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High intensity exercise</intervention_name>
    <arm_group_label>High intensity exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Moderate intensity exercise</intervention_name>
    <arm_group_label>Moderate intensity exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Advised to follow current guidelines for physical activity, but exercise on their own.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participating in the &quot;Generation 100&quot; study&#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>Accepts Healthy Volunteers</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>September 2022</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Prevention</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/NCT01680302
org study id: 2012/978b-2
nct id: NCT01680302
lead sponsor: 
collaborator: 
has dmc: No
This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75
      will be randomised to a moderate intensity training group, a high intensity training group or
      control group, with 3 years of exercise. The investigators will follow these persons and
      register all who develop atrial fibrillation during these 3 years, and at follow-up after
      ended intervention to see if there is differences in the number of persons who develop atrial
      fibrillation in the 3 groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of persons who develop atrial fibrillation during the 3 year intervention period
time frame: 3 years
description: People who already have the diagnosis before randomisation will not be counted.
measure: Number of persons who develop atrial fibrillation during the 6 years after randomisation
time frame: 6 years
arm group label: High intensity exercise
arm group type: Experimental
description: High intensity exercise(Borg 16) in intervals.
arm group label: Moderate intensity exercise
arm group type: Experimental
description: Moderate intensity exercise 3 times a week.
arm group label: Control group
arm group type: Experimental
description: Exercise on their own. Follow current guidelines.
intervention type: Behavioral
intervention name: High intensity exercise
arm group label: High intensity exercise
intervention type: Behavioral
intervention name: Moderate intensity exercise
arm group label: Moderate intensity exercise
intervention type: Behavioral
intervention name: Control
description: Advised to follow current guidelines for physical activity, but exercise on their own.
arm group label: Control group
criteria: 
gender: All
minimum age: 70 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Paal Loennechen, PhD
role: Study Chair
affiliation: St. Olavs Hospital
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Atrial Fibrillation