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The Application of Internet+ Home-based Cardiac Rehabilitation in Atrial Fibrillation Patients After RFCA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414007
Recruitment Status : Unknown
Verified May 2020 by Zhipeng BAO, Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Zhipeng BAO, Nanjing Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Cardiac Rehabilitation Behavioral: Internet+ home-based cardiac rehabilitation Behavioral: Conventional rehabilitation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Application of Internet+ Home-based Cardiac Rehabilitation Model in Atrial Fibrillation Patients After Radio Frequency Ablation
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Internet+ home-based cardiac rehabilitation group
The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
 Behavioral: Internet+ home-based cardiac rehabilitation
The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
Active Comparator: conventional care group
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.
 Behavioral: Conventional rehabilitation
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.


Outcome Measures
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Primary Outcome Measures :
  1. 6-minute walk test [ Time Frame: Change from Baseline 6-minute walk distance at 2 years ]
    exercise capacity

  2. Peak VO2 [ Time Frame: Change from Baseline Peak VO2 at 2 years ]
    exercise capacity

  3. sf-36 [ Time Frame: Change from Baseline sf-36 at 2 years ]
    Quality of Life


Secondary Outcome Measures :
  1. SAS [ Time Frame: Change from Baseline SAS scores at 2 years ]
    Anxious

  2. SDS [ Time Frame: Change from Baseline SDS scores at 2 years ]
    Depression

  3. PSQI [ Time Frame: Change from Baseline PSQI scores at 2 years ]
    sleep quality

  4. EHRA score [ Time Frame: Change from Baseline EHRA scores at 2 years ]
    AF burden

  5. AF recurrence [ Time Frame: Change from Baseline AF recurrence at 2 years ]
    patients still have episode of atrial fibrillation three months after ablation

  6. Adherence [ Time Frame: at 2 years ]
    Percentage of completed exercise prescription weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients diagnosed with atrial fibrillation and planned for treatment with radiofrequency catheter ablation (RFA) for AF;
  • Patients with age from 18 to 75 years;
  • Patients or primary caregiver are able to use smartphones;
  • Providing oral and written informed consent.

Exclusion Criteria:

  • Radiofrequency ablation was not performed for various reasons;
  • patients who were unable to understand the study due to severe cognitive impairment;
  • Patients with psychiatric disorders;
  • Patients with serious and instable body or severe complications;
  • Patients sufferring other exercise contraincations.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414007


Contacts
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Contact: Jie Wang, MD 18795883866 1500469549@qq.com
Contact: Zhipeng Bao, MD 15895903958 baozhipeng1219@163.com

Locations
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China, Jiangsu
The First Affiliated hospital of Nanjing Medical University Recruiting
Najing, Jiangsu, China, 210009
Contact: Guozhen Sun, MD    13851769549    gzsun100@126.com   
Contact: Jie Wang, MD    18795883866    1500469549@qq.com   
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Principal Investigator: Guozhen Sun, MD The First Affiliated Hospital with Nanjing Medical University
More Information
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Responsible Party: Zhipeng BAO, Principal Investigator, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04414007    
Other Study ID Numbers: 2020-SR-038
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes