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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital Hsin-Chu Branch

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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