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

NCT04414007 | Unknown

• 1 other identifier: 2020-SR-038
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• SAS

  Change from Baseline SAS scores at 2 years

• SDS

  Change from Baseline SDS scores at 2 years

• PSQI

  Change from Baseline PSQI scores at 2 years

• EHRA score

  Change from Baseline EHRA scores at 2 years

• AF recurrence

  Change from Baseline AF recurrence at 2 years

Study Arms (2)

Internet+ home-based cardiac rehabilitation group

EXPERIMENTAL

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

conventional care group

ACTIVE COMPARATOR

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

Interventions

Internet+ home-based cardiac rehabilitation BEHAVIORAL

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

Internet+ home-based cardiac rehabilitation group

Conventional rehabilitation 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.

conventional care group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The First Affiliated hospital of Nanjing Medical University

Najing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guozhen Sun, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Wang, MD

CONTACT

18795883866; 1500469549@qq.com

Zhipeng Bao, MD

CONTACT

15895903958; baozhipeng1219@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: January 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)