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

Study Overview
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Brief Summary
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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.

Official Title
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The Application of Internet+ Home-based Cardiac Rehabilitation Model in Atrial Fibrillation Patients After Radio Frequency Ablation

Conditions
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Atrial Fibrillation, Cardiac Rehabilitation

Intervention / Treatment
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* Behavioral: Internet+ home-based cardiac rehabilitation
* Behavioral: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet+ home-based cardiac rehabilitation group<br>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<br>* The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .<br>|
| Active Comparator: conventional care group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test | exercise capacity | Change from Baseline 6-minute walk distance at 2 years | 
| Peak VO2 | exercise capacity | Change from Baseline Peak VO2 at 2 years | 
| sf-36 | Quality of Life | Change from Baseline sf-36 at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAS | Anxious | Change from Baseline SAS scores at 2 years | 
| SDS | Depression | Change from Baseline SDS scores at 2 years | 
| PSQI | sleep quality | Change from Baseline PSQI scores at 2 years | 
| EHRA score | AF burden | Change from Baseline EHRA scores at 2 years | 
| AF recurrence | patients still have episode of atrial fibrillation three months after ablation | Change from Baseline AF recurrence at 2 years | 
| Adherence | Percentage of completed exercise prescription weeks | at 2 years |