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NCT Number: NCT06503445

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

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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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

education video

Other

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

the control group will watch the health educatopm video.

Primary outcomes

  1. Device measurement: physical activity

    Time frame: 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 outcomes

  1. IPAQ, International Physical Activity Questionnaire

    Time frame: 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.

  2. SF-36, short-form 36

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Other

Registry information

Official study title

The Impact of Video-based Cardiac Rehabilitation Education in Patients With Cardiovascular Implantable Electronic Devices(CIEDs)- a Randomized Controlled Trial

Acronym: CIEDs

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.