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

July 9, 2024 updated by: National Taiwan University Hospital Hsin-Chu Branch

The Impact of Video-based Cardiac Rehabilitation Education in Patients With Cardiovascular Implantable Electronic Devices(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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 300
        • National Taiwan University Hospital Hsin-Chu Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention.
Other: education video

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

the control group will watch the health educatopm video.
Sham Comparator: Control group
The control group with cardiac implantable electronic devices will receive only health education video intervention.
Other: education video

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

the control group will watch the health educatopm video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
We collected data on the day of case enrollment and twelve weeks later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
We collected data on the day of case enrollment and between 12 to 24 weeks later.
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.
We collected data on the day of case enrollment and between 12 to 24 weeks later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Investigators

  • Study Director: Min-Tsun Liao, PHD, National Taiwan University Hospital Hsin-Chu Branch Hsinchu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

April 20, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 109-064-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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