The Application of Internet+ Home-based Cardiac Rehabilitation in Atrial Fibrillation Patients After RFCA
Primary Purpose
Atrial Fibrillation, Cardiac Rehabilitation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Internet+ home-based cardiac rehabilitation
Conventional rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Atrial Fibrillation
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internet+ home-based cardiac rehabilitation group
conventional care group
Arm Description
The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
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.
Outcomes
Primary Outcome Measures
6-minute walk test
exercise capacity
Peak VO2
exercise capacity
sf-36
Quality of Life
Secondary Outcome Measures
SAS
Anxious
SDS
Depression
PSQI
sleep quality
EHRA score
AF burden
AF recurrence
patients still have episode of atrial fibrillation three months after ablation
Adherence
Percentage of completed exercise prescription weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04414007
Brief Title
The Application of Internet+ Home-based Cardiac Rehabilitation in Atrial Fibrillation Patients After RFCA
Official Title
The Application of Internet+ Home-based Cardiac Rehabilitation Model in Atrial Fibrillation Patients After Radio Frequency Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiac Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet+ home-based cardiac rehabilitation group
Arm Type
Experimental
Arm Description
The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
Arm Title
conventional care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet+ home-based cardiac rehabilitation
Intervention Description
The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
Intervention Type
Behavioral
Intervention Name(s)
Conventional rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-minute walk test
Description
exercise capacity
Time Frame
Change from Baseline 6-minute walk distance at 2 years
Title
Peak VO2
Description
exercise capacity
Time Frame
Change from Baseline Peak VO2 at 2 years
Title
sf-36
Description
Quality of Life
Time Frame
Change from Baseline sf-36 at 2 years
Secondary Outcome Measure Information:
Title
SAS
Description
Anxious
Time Frame
Change from Baseline SAS scores at 2 years
Title
SDS
Description
Depression
Time Frame
Change from Baseline SDS scores at 2 years
Title
PSQI
Description
sleep quality
Time Frame
Change from Baseline PSQI scores at 2 years
Title
EHRA score
Description
AF burden
Time Frame
Change from Baseline EHRA scores at 2 years
Title
AF recurrence
Description
patients still have episode of atrial fibrillation three months after ablation
Time Frame
Change from Baseline AF recurrence at 2 years
Title
Adherence
Description
Percentage of completed exercise prescription weeks
Time Frame
at 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Wang, MD
Phone
18795883866
Email
1500469549@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhipeng Bao, MD
Phone
15895903958
Email
baozhipeng1219@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guozhen Sun, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated hospital of Nanjing Medical University
City
Najing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guozhen Sun, MD
Phone
13851769549
Email
gzsun100@126.com
First Name & Middle Initial & Last Name & Degree
Jie Wang, MD
Phone
18795883866
Email
1500469549@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Application of Internet+ Home-based Cardiac Rehabilitation in Atrial Fibrillation Patients After RFCA
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