Investigation of the Effects of the Technology-based Cardiac Rehabilitation Program in Coronary Artery Patients

June 17, 2024 updated by: Dilara Saklica, Hacettepe University

Investigation of the Effects of Artificial Intelligence-supported and Technology-based Cardiac Rehabilitation Programs on Participation and Exercise Capacity in Coronary Artery Patients

This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

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.

Detailed Description

Cardiovascular diseases constitute one of the most critical health problems of today's society due to the loss of workforce, morbidity, mortality, and high hospital expenses.

This study was planned to investigate the effectiveness of technology-based and traditional cardiac rehabilitation programs in individuals with coronary artery disease.

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.
52

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with coronary artery disease
  • Access to the online program
  • Volunteering to participate in the research
  • Having an iOS or Android operating system compatible phone

Exclusion Criteria:

  • Having a musculoskeletal problem
  • Having uncontrolled hypertension
  • Having chronic heart failure (NYHA III-IV)
  • A history of acute coronary syndrome or surgical revascularization less than 12 months ago
  • More than 50% occlusion on the main coronary artery
  • Having arrhythmia

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Physiotherapist Supervised Exercise Training Group
Physiotherapist supervised exercise training in patients with coronary artery disease
Other: Physiotherapist supervised exercise training
Exercise training for 12 weeks will be given by video talk accompanied by a physiotherapist.
Experimental: Exercise Training Tracking from Phone-app Group
Exercise training tracking from phone app in patients with coronary artery disease
Other: Exercise training via phone app
Exercise training for 12 weeks will be given over the developed phone application.
Experimental: Control Group
General physical activity recommendations for home
Other: Physical activity recommendations
The program will be consist of 12 weeks of physical activity recommendations.

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
Exercise Capacity
Time Frame: Baseline, after 12 weeks, after 24 weeks
Exercise capacity will be evaluated using the incremental shuttle walk test.
Baseline, after 12 weeks, after 24 weeks
Participation
Time Frame: after 12 weeks
Participation will be evaluated using the number of sessions attended.
after 12 weeks

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
Peripheral muscle strength
Time Frame: Baseline, after 12 weeks, after 24 weeks
Peripheral muscle strength will be evaluated using the dynamometer.
Baseline, after 12 weeks, after 24 weeks
Endothelial function
Time Frame: Baseline, after 12 weeks, after 24 weeks
The endothelial function will be evaluated using echocardiography. After a resting baseline, Brachial artery diameter will be recorded, the cuff used in blood pressure measurement will be inflated 25-50 mmHg above the systolic blood pressure value and maintain that pressure for 5 min. The brachial artery diameter will be measured again after the cuff is deflated.
Baseline, after 12 weeks, after 24 weeks
Healthy Living Habit Evaluation
Time Frame: Baseline, after 12 weeks, after 24 weeks
Healthy living habit evaluation will be evaluated using the Healthy Lifestyle Behaviors Scale-II.
Baseline, after 12 weeks, after 24 weeks
Health-Related Quality of Life
Time Frame: Baseline, after 12 weeks, after 24 weeks
Health-Related Quality of Life will be evaluated using the Myocardial Infarction Dimensional Assessment Scale (MIDAS).
Baseline, after 12 weeks, after 24 weeks
QoL
Time Frame: Baseline, after 12 weeks, after 24 weeks
Quality of life will be evaluated using the SF-36 Short Form.
Baseline, after 12 weeks, after 24 weeks
Maximal Effort Capacity
Time Frame: Baseline
Maximal effort capacity will be evaluated using a cardiovascular stress test.
Baseline

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.
Hacettepe University

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: Naciye Vardar-Yagli, PhD, Hacettepe University
  • Study Director: Hikmet Yorgun, PhD, Hacettepe University
  • Study Chair: Ahmet Hakan Ates, PhD, Hacettepe University
  • Study Chair: Deniz Yuce, PhD, Hacettepe University
  • Principal Investigator: Dilara Saklica, MSc, Hacettepe University

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.
April 7, 2022

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.
May 1, 2024

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.
May 1, 2024

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).
February 19, 2022

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.
March 1, 2022

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.
March 3, 2022

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.
June 18, 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.
June 17, 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.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • KA-20105

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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