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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414007
• Other study ID #: 2020-SR-038
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2020
• Source: Nanjing Medical University
• Contact: Jie Wang, MD
• Phone: 18795883866
• Email: 1500469549[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Rehabilitation

Intervention

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 .
• 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.

Locations

Country	Name	City	State
China	The First Affiliated hospital of Nanjing Medical University	Najing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk test	exercise capacity	Change from Baseline 6-minute walk distance at 2 years
Primary	Peak VO2	exercise capacity	Change from Baseline Peak VO2 at 2 years
Primary	sf-36	Quality of Life	Change from Baseline sf-36 at 2 years
Secondary	SAS	Anxious	Change from Baseline SAS scores at 2 years
Secondary	SDS	Depression	Change from Baseline SDS scores at 2 years
Secondary	PSQI	sleep quality	Change from Baseline PSQI scores at 2 years
Secondary	EHRA score	AF burden	Change from Baseline EHRA scores at 2 years
Secondary	AF recurrence	patients still have episode of atrial fibrillation three months after ablation	Change from Baseline AF recurrence at 2 years
Secondary	Adherence	Percentage of completed exercise prescription weeks	at 2 years