Atrial FibrillationNCT04414007
The Application of Internet+ Home-based Cardiac Rehabilitation in Atrial Fibrillation Patients After RFCA
A study testing Internet+ home-based cardiac rehabilitation and Conventional rehabilitation in people with Atrial Fibrillation and Cardiac Rehabilitation, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Cardiac Rehabilitation
- What is being tested?
- Internet+ home-based cardiac rehabilitation and Conventional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated hospital of Nanjing Medical University
Najing, Jiangsu, 210009
Guozhen Sun, MD, 13851769549, gzsun100@126.com
Jie Wang, MD, 18795883866, 1500469549@qq.com
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation, Cardiac Rehabilitation
- Being tested
- Internet+ home-based cardiac rehabilitation, Conventional rehabilitation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet+ home-based cardiac rehabilitationBehavioural
The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
Conventional rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: Behavioral: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
exercise capacity
Measured: Change from Baseline 6-minute walk distance at 2 years
Peak VO2
exercise capacity
Measured: Change from Baseline Peak VO2 at 2 years
sf-36
Quality of Life
Measured: Change from Baseline sf-36 at 2 years
Secondary outcomes (6)
SAS
Anxious
Measured: Change from Baseline SAS scores at 2 years
SDS
Depression
Measured: Change from Baseline SDS scores at 2 years
PSQI
sleep quality
Measured: Change from Baseline PSQI scores at 2 years
EHRA score
AF burden
Measured: Change from Baseline EHRA scores at 2 years
AF recurrence
patients still have episode of atrial fibrillation three months after ablation
Measured: Change from Baseline AF recurrence at 2 years
Adherence
Percentage of completed exercise prescription weeks
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jan 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhipeng BAO, Nanjing Medical University
- Investigators
- Guozhen Sun, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414007
- Sponsor's protocol ID
- 2020-SR-038
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Internet+ Home-based Cardiac Rehabilitation Model in Atrial Fibrillation Patients After Radio Frequency Ablation
- ClinicalTrials.gov ID
- NCT04414007
- Acronym / sponsor ID
- 2020-SR-038
- Conditions
- Atrial Fibrillation, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet+ home-based cardiac rehabilitation group | Experimental | Behavioral: Internet+ home-based cardiac rehabilitationThe Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices . |
| conventional care group | Active comparator | Behavioral: Conventional rehabilitationThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet+ home-based cardiac rehabilitationThe Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices . | Behavioural | Internet+ home-based cardiac rehabilitation group |
| Conventional rehabilitationWe 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. | Behavioural | conventional care group |
Primary outcome
6-minute walk test
Time frame: Change from Baseline 6-minute walk distance at 2 years
exercise capacity
Peak VO2
Time frame: Change from Baseline Peak VO2 at 2 years
exercise capacity
sf-36
Time frame: Change from Baseline sf-36 at 2 years
Quality of Life
6 secondary outcomes
SAS
Time frame: Change from Baseline SAS scores at 2 years
SDS
Time frame: Change from Baseline SDS scores at 2 years
PSQI
Time frame: Change from Baseline PSQI scores at 2 years
EHRA score
Time frame: Change from Baseline EHRA scores at 2 years
AF recurrence
Time frame: Change from Baseline AF recurrence at 2 years
Adherence
Time frame: at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guozhen Sun, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet+ home-based cardiac rehabilitation and Conventional rehabilitation in people with Atrial Fibrillation and Cardiac Rehabilitation, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Wang, MD (18795883866, 1500469549@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: Change from Baseline 6-minute walk distance at 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.