The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs- a Randomized Controlled Trial

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

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2022-07-20

Brief Summary

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Cardiac rehabilitation has the beneficial effects of secondary prevention and social psychological and physical health status in patients with cardiovascular diseases. International and clinical guidelines currently recommend exercise training and rehabilitation for heart failure patients, which can effectively improve mortality and prognosis. However, few of these recommendations have specific recommendations for patients with cardiac implantable electronic devices. Currently the recommendations of cardiac rehabilitation include patients with coronary heart disease (acute coronary heart disease, any coronary revascularization, stable coronary disease or unstable angina), patients with heart failure, after cardiac surgery, and patients with high cardiovascular risk. Many of these patients may be implanted with cardiac implantable electronic devices. In 2011, 938 pacemakers, 140 cardiac resynchronization therapy and 149 implantable cardioverter defibrillators were implanted per million inhabitants in Europe. Therefore, among the groups with cardiac implantable electronic devices, cardiac rehabilitation plays a certain role. The purpose of this study is to evaluate whether video-based cardiac rehabilitation health education for patients with cardiac implantable electronic devices has significantly improved physical activity. This study is designed as a prospective, single center, double-blind, randomized controlled trial. Divided into an experimental group and a control group at a ratio of 1:1. The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention, and the control group will receive only health education. We aim to recruit 45 participants per group with a total of 90 participants.

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Detailed Description

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Conditions

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Patients With Cardiac Implantable Electronic Devices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Interventional group

The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention.

Group Type EXPERIMENTAL

education video

Intervention Type OTHER

the intervention group will watch the cardiac reahbiltation health education video.

the control group will watch the health educatopm video.

Control group

The control group with cardiac implantable electronic devices will receive only health education video intervention.

Group Type SHAM_COMPARATOR

education video

Intervention Type OTHER

the intervention group will watch the cardiac reahbiltation health education video.

the control group will watch the health educatopm video.

Interventions

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education video

the intervention group will watch the cardiac reahbiltation health education video.

the control group will watch the health educatopm video.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 20-100 years old
* Patients with cardiovascular implantable electronic devices(CIEDs)
* CIEDs were implanted for more than 30 days without complications

Exclusion Criteria

* cannot sign informed consent
* cannot return for follow-up visits current or scheduled enrollment in other conflicting studies
* concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months
* patients with bed-ridden status could not perform home-based tele-rehabilitation
* pregnancy

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No