The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs- a Randomized Controlled Trial
NCT Number: NCT06503445
Acronym: CIEDs
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patients With Cardiac Implantable Electronic Devices
Interventions: OTHER: education video
Sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 85
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2021-03-03
Completion Date: 2022-07-20
Locations: National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, 300, Taiwan

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.

Primary Outcome Measures: Device measurement: physical activity, use CIEDs to measure, it shows as how many hours of physical activity a day., We collected data on the day of case enrollment and twelve weeks later.
Secondary Outcome Measures: IPAQ, International Physical Activity Questionnaire, 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., We collected data on the day of case enrollment and between 12 to 24 weeks later.|SF-36, short-form 36, 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., We collected data on the day of case enrollment and between 12 to 24 weeks later.