<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/NCT04414007</url>
  </required_header>
  <id_info>
    <org_study_id>2020-SR-038</org_study_id>
    <nct_id>NCT04414007</nct_id>
  </id_info>
  <brief_title>The Application of Internet+ Home-based Cardiac Rehabilitation in Atrial Fibrillation Patients After RFCA</brief_title>
  <official_title>The Application of Internet+ Home-based Cardiac Rehabilitation Model in Atrial Fibrillation Patients After Radio Frequency Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</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>
      Epidemiological reports show that the incidence of atrial fibrillation continues to increase.&#xD;
      AF is the most common arrhythmia with high mortality and disability rate. Radio frequency&#xD;
      ablation has good therapeutic effect of AF symptoms. However, even after successful radio&#xD;
      frequency ablation, there are still many discomforts that deserve medical attention. The&#xD;
      benefits of cardiac rehabilitation for patients with heart disease have been recognized，but&#xD;
      the adherence with cardiac rehabilitation is not satisfactory. Home-based rehabilitation has&#xD;
      received increasing recognition because it has overcome many obstacles for patients to&#xD;
      participate in cardiac rehabilitation. The application of Internet+ follow-up mode and&#xD;
      intelligent wearable devices provide new ideas for home-based cardiac rehabilitation with the&#xD;
      progress of information technology nowadays. This study used an experimental research design.&#xD;
      The aim was to explore the application effects of Internet platform and wearable devices in&#xD;
      home-based cardiac rehabilitation in patients with atrial fibrillation after radio frequency&#xD;
      ablation. The final goal is to provide the basis for the development and application of this&#xD;
      kind of home-based cardiac rehabilitation care in patients with atrial fibrillation after&#xD;
      radio frequency ablation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6-minute walk test</measure>
    <time_frame>Change from Baseline 6-minute walk distance at 2 years</time_frame>
    <description>exercise capacity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak VO2</measure>
    <time_frame>Change from Baseline Peak VO2 at 2 years</time_frame>
    <description>exercise capacity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sf-36</measure>
    <time_frame>Change from Baseline sf-36 at 2 years</time_frame>
    <description>Quality of Life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SAS</measure>
    <time_frame>Change from Baseline SAS scores at 2 years</time_frame>
    <description>Anxious</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SDS</measure>
    <time_frame>Change from Baseline SDS scores at 2 years</time_frame>
    <description>Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSQI</measure>
    <time_frame>Change from Baseline PSQI scores at 2 years</time_frame>
    <description>sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EHRA score</measure>
    <time_frame>Change from Baseline EHRA scores at 2 years</time_frame>
    <description>AF burden</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AF recurrence</measure>
    <time_frame>Change from Baseline AF recurrence at 2 years</time_frame>
    <description>patients still have episode of atrial fibrillation three months after ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>at 2 years</time_frame>
    <description>Percentage of completed exercise prescription weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Cardiac Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Internet+ home-based cardiac rehabilitation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional care group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The UC-assigned patients will maintain standard of care.The conventional rehabilitation group received routine medical care and traditional home-based cardiac rehabilitation based on the rehabilitation manual and exercise diary, followed up by telephone and outpatient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet+ home-based cardiac rehabilitation</intervention_name>
    <description>The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .</description>
    <arm_group_label>Internet+ home-based cardiac rehabilitation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional rehabilitation</intervention_name>
    <description>We provide patients with cardiac rehabilitation manuals and exercise logs. 4 weeks after ablation，Patients have CPET.Their exercise prescription was made according to CPET .The patients have rehabilitation training at home and recorded their exercise data including exercise time、type、frequency and average heart rate.</description>
    <arm_group_label>conventional care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed with atrial fibrillation and planned for treatment with&#xD;
             radiofrequency catheter ablation (RFA) for AF;&#xD;
&#xD;
          -  Patients with age from 18 to 75 years;&#xD;
&#xD;
          -  Patients or primary caregiver are able to use smartphones;&#xD;
&#xD;
          -  Providing oral and written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radiofrequency ablation was not performed for various reasons;&#xD;
&#xD;
          -  patients who were unable to understand the study due to severe cognitive impairment;&#xD;
&#xD;
          -  Patients with psychiatric disorders;&#xD;
&#xD;
          -  Patients with serious and instable body or severe complications;&#xD;
&#xD;
          -  Patients sufferring other exercise contraincations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guozhen Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jie Wang, MD</last_name>
    <phone>18795883866</phone>
    <email>1500469549@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhipeng Bao, MD</last_name>
    <phone>15895903958</phone>
    <email>baozhipeng1219@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated hospital of Nanjing Medical University</name>
      <address>
        <city>Najing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guozhen Sun, MD</last_name>
      <phone>13851769549</phone>
      <email>gzsun100@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Jie Wang, MD</last_name>
      <phone>18795883866</phone>
      <email>1500469549@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Zhipeng BAO</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04414007
org study id: 2020-SR-038
nct id: NCT04414007
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Epidemiological reports show that the incidence of atrial fibrillation continues to increase.
      AF is the most common arrhythmia with high mortality and disability rate. Radio frequency
      ablation has good therapeutic effect of AF symptoms. However, even after successful radio
      frequency ablation, there are still many discomforts that deserve medical attention. The
      benefits of cardiac rehabilitation for patients with heart disease have been recognized，but
      the adherence with cardiac rehabilitation is not satisfactory. Home-based rehabilitation has
      received increasing recognition because it has overcome many obstacles for patients to
      participate in cardiac rehabilitation. The application of Internet+ follow-up mode and
      intelligent wearable devices provide new ideas for home-based cardiac rehabilitation with the
      progress of information technology nowadays. This study used an experimental research design.
      The aim was to explore the application effects of Internet platform and wearable devices in
      home-based cardiac rehabilitation in patients with atrial fibrillation after radio frequency
      ablation. The final goal is to provide the basis for the development and application of this
      kind of home-based cardiac rehabilitation care in patients with atrial fibrillation after
      radio frequency ablation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: 6-minute walk test
time frame: Change from Baseline 6-minute walk distance at 2 years
description: exercise capacity
measure: Peak VO2
time frame: Change from Baseline Peak VO2 at 2 years
description: exercise capacity
measure: sf-36
time frame: Change from Baseline sf-36 at 2 years
description: Quality of Life
measure: SAS
time frame: Change from Baseline SAS scores at 2 years
description: Anxious
measure: SDS
time frame: Change from Baseline SDS scores at 2 years
description: Depression
measure: PSQI
time frame: Change from Baseline PSQI scores at 2 years
description: sleep quality
measure: EHRA score
time frame: Change from Baseline EHRA scores at 2 years
description: AF burden
measure: AF recurrence
time frame: Change from Baseline AF recurrence at 2 years
description: patients still have episode of atrial fibrillation three months after ablation
measure: Adherence
time frame: at 2 years
description: Percentage of completed exercise prescription weeks
arm group label: Internet+ home-based cardiac rehabilitation group
arm group type: Experimental
description: The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
arm group label: conventional care group
arm group type: Active Comparator
description: The UC-assigned patients will maintain standard of care.The conventional rehabilitation group received routine medical care and traditional home-based cardiac rehabilitation based on the rehabilitation manual and exercise diary, followed up by telephone and outpatient.
intervention type: Behavioral
intervention name: Internet+ home-based cardiac rehabilitation
description: The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
arm group label: Internet+ home-based cardiac rehabilitation group
intervention type: Behavioral
intervention name: Conventional rehabilitation
description: We provide patients with cardiac rehabilitation manuals and exercise logs. 4 weeks after ablation，Patients have CPET.Their exercise prescription was made according to CPET .The patients have rehabilitation training at home and recorded their exercise data including exercise time、type、frequency and average heart rate.
arm group label: conventional care group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Guozhen Sun, MD
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Jie Wang, MD
phone: 18795883866
email: 1500469549@qq.com
last name: Zhipeng Bao, MD
phone: 15895903958
email: baozhipeng1219@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Zhipeng BAO
investigator title: Principal Investigator
mesh term: Atrial Fibrillation
sharing ipd: No