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

Not Applicable

Completed

• Conditions: Patients With Cardiac Implantable Electronic Devices
• Interventions: Other: education video

• Registration Number: NCT06503445
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Primary Completion: 2022-04-20
• Study Completion: 2022-07-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	education video	The control group with cardiac implantable electronic devices will receive only health education video intervention.
Interventional group	education video	The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention.

Primary Outcome Measures

Name	Time	Method
Device measurement: physical activity	We collected data on the day of case enrollment and twelve weeks later.	use CIEDs to measure, it shows as how many hours of physical activity a day.

Secondary Outcome Measures

Name	Time	Method
IPAQ, International Physical Activity Questionnaire	We collected data on the day of case enrollment and between 12 to 24 weeks later.	The total physical activity score is calculated by summing the duration and frequency of vigorous, moderate, and walking activities. Higher scores indicate a higher physical activity.
SF-36, short-form 36	We collected data on the day of case enrollment and between 12 to 24 weeks later.	SF-36 is used to evaluate the "quality of life", range form 0-100. The survey results are interpreted in two main way: Domain Scores and Summary Scores. Higher scores represent better quality of life.

Trial Locations

Locations (1)

National Taiwan University Hospital Hsin-Chu Branch; 🇨🇳 Hsinchu, Taiwan