<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/NCT01721863</url>
  </required_header>
  <id_info>
    <org_study_id>201010032R</org_study_id>
    <nct_id>NCT01721863</nct_id>
  </id_info>
  <brief_title>Effects of Exercise Training in Patients With Permanent Atrial Fibrillation</brief_title>
  <official_title>Effects of Exercise Training on Endothelial Function, Heart Rate Variability, Exercise Capacity, and Quality of Life in Patients With Permanent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms&#xD;
      of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with&#xD;
      increased vagal tone. Patients with AF have poor exercise capacity that may contribute to&#xD;
      decreased atrial effective refractory period, and decreased cardiac output and heart rate&#xD;
      reserve, and may result in poor quality of life. Poor endothelial function had been noted in&#xD;
      patients with AF, associated with increased risks of cerebrovascular and cardiovascular&#xD;
      disease. Exercise training has been noted to improve exercise capacity and quality of life in&#xD;
      patients with AF only in some studies. Endothelial function can be improved by exercise&#xD;
      training in patients with cardiovascular disease, but no report in patients with AF. Evidence&#xD;
      of exercise training is still needed in patients with AF. The purpose of this study is to&#xD;
      investigate the effect of exercise training on&#xD;
&#xD;
        1. endothelial function&#xD;
&#xD;
        2. heart rate variability&#xD;
&#xD;
        3. exercise capacity&#xD;
&#xD;
        4. quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled study was implemented to examine :(1) the effect of interval aerobic&#xD;
      exercise training combined with resistance training on endothelial function, heart rate&#xD;
      variability (HRV), exercise capacity, and quality of life (QoL); (2) the influential factors&#xD;
      related to exercise capacity, and the relationship between exercise capacity and quality of&#xD;
      life in patients with permanent atrial fibrillation (AF).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>Phase 1</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 of exercise capacity (after intervention)</measure>
    <time_frame>At baseline and 12 weeks after intervention</time_frame>
    <description>To measure maximal oxygen consumption, maximal oxygen pulse, maximal heart rate and blood pressure, cumulated and peak workload by cycle ergometer with Vmax 229 system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of heart rate variability (after intervention)</measure>
    <time_frame>At baseline and 12 weeks after intervention</time_frame>
    <description>To record ECG by lead V1 with KENZ 170 on supine position for 1 hour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change values of head up tilt test (after intervention)</measure>
    <time_frame>At baseline and 12 weeks after intervention</time_frame>
    <description>Subjects were tilted up 60 degree on tilting table for 15 minutes to record the change of blood pressure and heart rate, and heart rate variability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of endothelial function (after intervention)</measure>
    <time_frame>At baseline and 12 weeks after intervention</time_frame>
    <description>To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of quality of life (after intervention)</measure>
    <time_frame>At baseline and 12 weeks after intervention</time_frame>
    <description>To measure quality of life by Short-form 36 and symptom checklist</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group conducted the usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training</intervention_name>
    <description>Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.</description>
    <arm_group_label>Exercise training</arm_group_label>
    <other_name>Aerobic exercise Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Permanent atrial fibrillation≥ 1 year aged 40-76 years&#xD;
&#xD;
          -  Recurrence AF after ablation&#xD;
&#xD;
          -  Under antiarrhythmia medication control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CAD or myocardial infrarction history&#xD;
&#xD;
          -  NYHA≥ III-IV, or LVEF≤45%&#xD;
&#xD;
          -  Mitral or aortic valve regurgitation ≥ Gr. II&#xD;
&#xD;
          -  Mitral valve or aortic valve stenosis&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  Cardioversion by ablation&#xD;
&#xD;
          -  Pulmonary artery hypertension&#xD;
&#xD;
          -  Any surgery in previous 3 months&#xD;
&#xD;
          -  Any neurological disorders&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Severe musculoskeletal disorder&#xD;
&#xD;
          -  Hyperthyroidism&#xD;
&#xD;
          -  Premenopausal women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying-Tai Wu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>November 22, 2010</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Exercise Training</keyword>
  <keyword>Endothelial Function</keyword>
  <keyword>Autonomic Nerve Modulation</keyword>
  <keyword>Exercise Capacity</keyword>
  <keyword>Quality of Life</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/NCT01721863
org study id: 201010032R
nct id: NCT01721863
lead sponsor: 
has dmc: No
Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms
      of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with
      increased vagal tone. Patients with AF have poor exercise capacity that may contribute to
      decreased atrial effective refractory period, and decreased cardiac output and heart rate
      reserve, and may result in poor quality of life. Poor endothelial function had been noted in
      patients with AF, associated with increased risks of cerebrovascular and cardiovascular
      disease. Exercise training has been noted to improve exercise capacity and quality of life in
      patients with AF only in some studies. Endothelial function can be improved by exercise
      training in patients with cardiovascular disease, but no report in patients with AF. Evidence
      of exercise training is still needed in patients with AF. The purpose of this study is to
      investigate the effect of exercise training on

        1. endothelial function

        2. heart rate variability

        3. exercise capacity

        4. quality of life.
A randomized controlled study was implemented to examine :(1) the effect of interval aerobic
      exercise training combined with resistance training on endothelial function, heart rate
      variability (HRV), exercise capacity, and quality of life (QoL); (2) the influential factors
      related to exercise capacity, and the relationship between exercise capacity and quality of
      life in patients with permanent atrial fibrillation (AF).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change of exercise capacity (after intervention)
time frame: At baseline and 12 weeks after intervention
description: To measure maximal oxygen consumption, maximal oxygen pulse, maximal heart rate and blood pressure, cumulated and peak workload by cycle ergometer with Vmax 229 system
measure: Change of heart rate variability (after intervention)
time frame: At baseline and 12 weeks after intervention
description: To record ECG by lead V1 with KENZ 170 on supine position for 1 hour
measure: Change values of head up tilt test (after intervention)
time frame: At baseline and 12 weeks after intervention
description: Subjects were tilted up 60 degree on tilting table for 15 minutes to record the change of blood pressure and heart rate, and heart rate variability.
measure: Change of endothelial function (after intervention)
time frame: At baseline and 12 weeks after intervention
description: To measure dependent-endothelial moulation by flow-mediated dilatation with Sonosite 180 portable ultrasound.
measure: Change of quality of life (after intervention)
time frame: At baseline and 12 weeks after intervention
description: To measure quality of life by Short-form 36 and symptom checklist
arm group label: Exercise training
arm group type: Experimental
description: Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
arm group label: control group
arm group type: No Intervention
description: Control group conducted the usual care
intervention type: Other
intervention name: Exercise training
description: Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
arm group label: Exercise training
other name: Aerobic exercise Training
criteria: 
gender: All
minimum age: 40 Years
maximum age: 76 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ying-Tai Wu, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Atrial Fibrillation