Clinical trial NCT06503445: The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs- a Randomized Controlled Trial
Official title: The Impact of Video-based Cardiac Rehabilitation Education in Patients With Cardiovascular Implantable Electronic Devices(CIEDs)- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Cardiac Implantable Electronic Devices
Keywords: Cardiac implantable electronic device
cardiac rehabilitation
video-based education
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Device measurement: physical activity
timeFrame: We collected data on the day of case enrollment and twelve weeks later.
Secondary outcomes:
measure: IPAQ, International Physical Activity Questionnaire
timeFrame: We collected data on the day of case enrollment and between 12 to 24 weeks later.
measure: SF-36, short-form 36
timeFrame: We collected data on the day of case enrollment and between 12 to 24 weeks later.
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch Hsinchu
name: Min-Tsun Liao, PHD
role: STUDY_DIRECTOR
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