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

NCT ID: NCT04414007

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-06-30

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.

Detailed Description

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Conditions

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Atrial Fibrillation Cardiac Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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 .

Group Type EXPERIMENTAL

Internet+ home-based cardiac rehabilitation

Intervention Type BEHAVIORAL

The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .

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.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type BEHAVIORAL

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.

Interventions

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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 .

Intervention Type 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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhipeng BAO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guozhen Sun, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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The First Affiliated hospital of Nanjing Medical University

Najing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Wang, MD

Role: CONTACT

18795883866

Zhipeng Bao, MD

Role: CONTACT

15895903958

Facility Contacts

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Guozhen Sun, MD

Role: primary

13851769549

Jie Wang, MD

Role: backup

18795883866

Other Identifiers

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2020-SR-038

Identifier Type: -

Identifier Source: org_study_id

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