Arrhythmia, Bradycardia, Heart Failure
Conditions
Keywords
Cardiac implantable electronic device, cardiac rehabilitation, video-based education
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.
Interventions
OTHEReducation video
the intervention group will watch the cardiac reahbiltation health education video. the control group will watch the health educatopm video.
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device measurement: physical activity | We collected data on the day of case enrollment and twelve weeks later. | use Cardiovascular implantable electronic devices to measure, it shows as how many hours of physical activity a day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. Minimun score is 0 and there isn't a theoretical maximum score. |
| 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. |
Countries
Taiwan
Contacts
STUDY_DIRECTORMin-Tsun Liao, PHD
National Taiwan University Hospital Hsin-Chu Branch Hsinchu
Outcome results
None listed