<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/NCT03241433</url>
  </required_header>
  <id_info>
    <org_study_id>1703M11461</org_study_id>
    <nct_id>NCT03241433</nct_id>
  </id_info>
  <brief_title>High-Intensity Aerobic Lifelong Training--AF</brief_title>
  <acronym>HALT-AF</acronym>
  <official_title>High-Intensity Interval Training and Moderate-Intensity Continuous Training in Reducing Atrial Fibrillation Burden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a single-center RCT. Potential subjects with symptomatic non-permanent AF will&#xD;
      be enrolled to determine the effect of sprint interval training (SIT) in comparison to&#xD;
      moderate-intensity continuous training (MICT) and non-exercise control in reducing AF burden.&#xD;
      The Investigators will enroll 60 patients during the first 12 months of the study. Baseline&#xD;
      data collection will be conducted during the first month after enrollment. After baseline&#xD;
      data collection, subjects will be randomized (1:1:1) to SIT vs. MICT vs. non-exercise&#xD;
      controls. The exercise training will last for 3 months followed by final data collection&#xD;
      which will be completed in 1 month.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation (AF) is the most common heart rhythm abnormality in the general&#xD;
      population. Current recommended methods to maintain sinus rhythm or reduce AF burden (% time&#xD;
      a person is in AF) in patients with non-permanent AF are costly and ineffective. Hence, there&#xD;
      is an urgent need to discover novel inexpensive strategies to reduce AF burden. It is&#xD;
      well-established that regular aerobic exercise reduces cardiovascular morbidity and&#xD;
      mortality; however, adherence to regular exercise is poor rendering it an ineffective public&#xD;
      health strategy. Evidence is emerging to suggest that traditional moderate-intensity&#xD;
      continuous training (MICT) and high-intensity interval training (HIIT) may be associated with&#xD;
      lower AF burden. Compared with traditional MICT, HIIT is possibly more time-efficient; hence,&#xD;
      it may promote adherence. Since lack of time is the most common reason for poor adherence to&#xD;
      regular exercise, the time-efficiency of HIIT holds promise to be a &quot;game-changer&quot;. However,&#xD;
      many knowledge gaps remain. First, HIIT has never been compared directly with MICT in&#xD;
      relation to AF burden; thus, whether HIIT is comparable or superior to MICT is unknown.&#xD;
      Second, the time commitment required for a &quot;conventional&quot; HIIT program (120 mins/week) is not&#xD;
      substantially less than the recommended MICT (150 mins/week); hence, it is doubtful that it&#xD;
      can be a real &quot;game-changer&quot; in terms of promoting adherence. Third, HIIT performed using a&#xD;
      cycle ergometer is a safer alternative to the treadmill in older adults, but has not been&#xD;
      evaluated in patients with AF. Finally, mechanisms underlying the salutary benefits of&#xD;
      exercise in relation to AF burden remain unknown. To address these knowledge gaps, the&#xD;
      investigators will evaluate an innovative HIIT program-sprint interval training (SIT)-using a&#xD;
      cycle ergometer that only requires 10 minutes per session and 30 minutes per week, in&#xD;
      contrast to the &quot;conventional&quot; HIIT program that requires 40 minutes per session and 120&#xD;
      minutes per week. In this pilot randomized controlled trial (RCT), the investigators will&#xD;
      randomize 60 subjects with non-permanent AF (1:1:1) to SIT vs. MICT vs. no exercise control.&#xD;
      At enrollment, these subjects will undergo heart rhythm monitoring by a non-invasive&#xD;
      ambulatory heart rhythm monitor, V02 max testing, assessment of cardiac size and function by&#xD;
      cardiac MRI, and assessment of AF symptom severity; these measures will be repeated at 3&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">December 18, 2019</completion_date>
  <primary_completion_date type="Actual">December 18, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in AF burden</measure>
    <time_frame>3 months</time_frame>
    <description>After 12 weeks of exercise training , HIIT and MICT will be comparable but better than non-exercise control in AFburden(% of time a person is in AF) by using an ambulatory patch monitor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in left atrial and left ventricular size and function</measure>
    <time_frame>3 months</time_frame>
    <description>After 12 weeks of exercise training HIIT and MICT will be comparable but better than non-exercise control as Cardiac MRI will be completed to assess LV and LA volumes and function and LV fibrosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in clinical outcomes</measure>
    <time_frame>3 months</time_frame>
    <description>The favorable effect of HIIT and MICT over non exercise control on clinical outcomes will be attenuated after after for secondary outcomes, suggesting that the latter mediate the clinical benefits of regular aerobic exercise</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>High intensity interval training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 3 X 20-second sprint interval cycling -as fast as possible at 90-95% peak power low intensity- 2 X 2 minute cycling at slow pace 50W</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate intensity continuous training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 45 minutes of continuous cycling at 45-60% peak power</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No excercise training will be done</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High intensity interval training</intervention_name>
    <description>exercise by use of stationary cycles</description>
    <arm_group_label>High intensity interval training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moderate intensity continuous training</intervention_name>
    <description>exercise by use of stationary cycles</description>
    <arm_group_label>Moderate intensity continuous training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Exercise</intervention_name>
    <description>no exercise training will be given and no exercise will be added to subjects routine</description>
    <arm_group_label>No exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  : Patients with symptomatic non-permanent AF and aged 18-65 years who are sedentary&#xD;
             (activity ≤0.5 hours/week of regular exercise) and seen by Dr. Chen or his cardiology&#xD;
             colleagues at Clinics and Surgery Center (CSC), other Fairview cardiology clinics, and&#xD;
             University of Minnesota Medical Center (UMMC). Patients will be screened and enrolled&#xD;
             by a research coordinator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals lacking the capacity to consent for themselves will not be included,&#xD;
             previous open heart surgery, previous catheter ablation for AF, LVEF &lt;45%, significant&#xD;
             cardiac valve disease, coronary heart disease without complete revascularization,&#xD;
             implanted cardiac electronic device, or GFR &lt;30 mL/min/1.73 m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin Yee Chen, MD,MBBS,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>December 18, 2019</last_update_submitted>
  <last_update_submitted_qc>December 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03241433
org study id: 1703M11461
nct id: NCT03241433
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a single-center RCT. Potential subjects with symptomatic non-permanent AF will
      be enrolled to determine the effect of sprint interval training (SIT) in comparison to
      moderate-intensity continuous training (MICT) and non-exercise control in reducing AF burden.
      The Investigators will enroll 60 patients during the first 12 months of the study. Baseline
      data collection will be conducted during the first month after enrollment. After baseline
      data collection, subjects will be randomized (1:1:1) to SIT vs. MICT vs. non-exercise
      controls. The exercise training will last for 3 months followed by final data collection
      which will be completed in 1 month.
Atrial fibrillation (AF) is the most common heart rhythm abnormality in the general
      population. Current recommended methods to maintain sinus rhythm or reduce AF burden (% time
      a person is in AF) in patients with non-permanent AF are costly and ineffective. Hence, there
      is an urgent need to discover novel inexpensive strategies to reduce AF burden. It is
      well-established that regular aerobic exercise reduces cardiovascular morbidity and
      mortality; however, adherence to regular exercise is poor rendering it an ineffective public
      health strategy. Evidence is emerging to suggest that traditional moderate-intensity
      continuous training (MICT) and high-intensity interval training (HIIT) may be associated with
      lower AF burden. Compared with traditional MICT, HIIT is possibly more time-efficient; hence,
      it may promote adherence. Since lack of time is the most common reason for poor adherence to
      regular exercise, the time-efficiency of HIIT holds promise to be a "game-changer". However,
      many knowledge gaps remain. First, HIIT has never been compared directly with MICT in
      relation to AF burden; thus, whether HIIT is comparable or superior to MICT is unknown.
      Second, the time commitment required for a "conventional" HIIT program (120 mins/week) is not
      substantially less than the recommended MICT (150 mins/week); hence, it is doubtful that it
      can be a real "game-changer" in terms of promoting adherence. Third, HIIT performed using a
      cycle ergometer is a safer alternative to the treadmill in older adults, but has not been
      evaluated in patients with AF. Finally, mechanisms underlying the salutary benefits of
      exercise in relation to AF burden remain unknown. To address these knowledge gaps, the
      investigators will evaluate an innovative HIIT program-sprint interval training (SIT)-using a
      cycle ergometer that only requires 10 minutes per session and 30 minutes per week, in
      contrast to the "conventional" HIIT program that requires 40 minutes per session and 120
      minutes per week. In this pilot randomized controlled trial (RCT), the investigators will
      randomize 60 subjects with non-permanent AF (1:1:1) to SIT vs. MICT vs. no exercise control.
      At enrollment, these subjects will undergo heart rhythm monitoring by a non-invasive
      ambulatory heart rhythm monitor, V02 max testing, assessment of cardiac size and function by
      cardiac MRI, and assessment of AF symptom severity; these measures will be repeated at 3
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in AF burden
time frame: 3 months
description: After 12 weeks of exercise training , HIIT and MICT will be comparable but better than non-exercise control in AFburden(% of time a person is in AF) by using an ambulatory patch monitor
measure: Change in left atrial and left ventricular size and function
time frame: 3 months
description: After 12 weeks of exercise training HIIT and MICT will be comparable but better than non-exercise control as Cardiac MRI will be completed to assess LV and LA volumes and function and LV fibrosis
measure: change in clinical outcomes
time frame: 3 months
description: The favorable effect of HIIT and MICT over non exercise control on clinical outcomes will be attenuated after after for secondary outcomes, suggesting that the latter mediate the clinical benefits of regular aerobic exercise
arm group label: High intensity interval training
arm group type: Active Comparator
description: Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 3 X 20-second sprint interval cycling -as fast as possible at 90-95% peak power low intensity- 2 X 2 minute cycling at slow pace 50W
arm group label: Moderate intensity continuous training
arm group type: Active Comparator
description: Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 45 minutes of continuous cycling at 45-60% peak power
arm group label: No exercise
arm group type: Active Comparator
description: No excercise training will be done
intervention type: Other
intervention name: High intensity interval training
description: exercise by use of stationary cycles
arm group label: High intensity interval training
intervention type: Other
intervention name: Moderate intensity continuous training
description: exercise by use of stationary cycles
arm group label: Moderate intensity continuous training
intervention type: Other
intervention name: No Exercise
description: no exercise training will be given and no exercise will be added to subjects routine
arm group label: No exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lin Yee Chen, MD,MBBS,MS
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No