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

Not Applicable

• Conditions: Cardiac Rehabilitation; Atrial Fibrillation

• Registration Number: NCT04414007
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-30
• Last Update Submitted: 2020-05-30
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6-minute walk test	Change from Baseline 6-minute walk distance at 2 years	exercise capacity
Peak VO2	Change from Baseline Peak VO2 at 2 years	exercise capacity
sf-36	Change from Baseline sf-36 at 2 years	Quality of Life

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated hospital of Nanjing Medical University; 🇨🇳 Najing, Jiangsu, China

The First Affiliated hospital of Nanjing Medical University

🇨🇳Najing, Jiangsu, China

Guozhen Sun, MD

Contact

13851769549

gzsun100@126.com

Jie Wang, MD

Contact

18795883866

1500469549@qq.com