Clinical trial NCT04414007: The Application of Internet+ Home-based Cardiac Rehabilitation in Atrial Fibrillation Patients After RFCA
Official title: The Application of Internet+ Home-based Cardiac Rehabilitation Model in Atrial Fibrillation Patients After Radio Frequency Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Cardiac Rehabilitation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: 6-minute walk test
timeFrame: Change from Baseline 6-minute walk distance at 2 years
measure: Peak VO2
timeFrame: Change from Baseline Peak VO2 at 2 years
measure: sf-36
timeFrame: Change from Baseline sf-36 at 2 years
Secondary outcomes:
measure: SAS
timeFrame: Change from Baseline SAS scores at 2 years
measure: SDS
timeFrame: Change from Baseline SDS scores at 2 years
measure: PSQI
timeFrame: Change from Baseline PSQI scores at 2 years
measure: EHRA score
timeFrame: Change from Baseline EHRA scores at 2 years
measure: AF recurrence
timeFrame: Change from Baseline AF recurrence at 2 years
measure: Adherence
timeFrame: at 2 years
Other outcomes:
Locations:
city: Najing
country: China
facility: The First Affiliated hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Guozhen Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: