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

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Cardiac Rehabilitation
• Intervention / Treatment: Behavioral: Internet+ home-based cardiac rehabilitation; Behavioral: Conventional rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Najing, Jiangsu, China, 210009
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Jie Wang, MD; Phone Number: 18795883866; Email: 1500469549@qq.com
      • Contact: Guozhen Sun, MD; Phone Number: 13851769549; Email: gzsun100@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Principal Investigator: Guozhen Sun, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 30, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 30, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2020-SR-038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No