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

May 30, 2020 updated by: Zhipeng BAO, Nanjing Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Najing, Jiangsu, China, 210009
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-minute walk test
Time Frame: Change from Baseline 6-minute walk distance at 2 years
exercise capacity
Change from Baseline 6-minute walk distance at 2 years
Peak VO2
Time Frame: Change from Baseline Peak VO2 at 2 years
exercise capacity
Change from Baseline Peak VO2 at 2 years
sf-36
Time Frame: Change from Baseline sf-36 at 2 years
Quality of Life
Change from Baseline sf-36 at 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAS
Time Frame: Change from Baseline SAS scores at 2 years
Anxious
Change from Baseline SAS scores at 2 years
SDS
Time Frame: Change from Baseline SDS scores at 2 years
Depression
Change from Baseline SDS scores at 2 years
PSQI
Time Frame: Change from Baseline PSQI scores at 2 years
sleep quality
Change from Baseline PSQI scores at 2 years
EHRA score
Time Frame: Change from Baseline EHRA scores at 2 years
AF burden
Change from Baseline EHRA scores at 2 years
AF recurrence
Time Frame: Change from Baseline AF recurrence at 2 years
patients still have episode of atrial fibrillation three months after ablation
Change from Baseline AF recurrence at 2 years
Adherence
Time Frame: at 2 years
Percentage of completed exercise prescription weeks
at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guozhen Sun, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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