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

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: Completed
• Conditions: Coronary Artery Disease; Physical Inactivity
• Intervention / Treatment: Other: Physiotherapist supervised exercise training; Other: Exercise training via phone app; Other: Physical activity recommendations

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: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle strength	Peripheral muscle strength will be evaluated using the dynamometer.	Baseline, after 12 weeks, after 24 weeks
Endothelial function	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	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	Health-Related Quality of Life will be evaluated using the Myocardial Infarction Dimensional Assessment Scale (MIDAS).	Baseline, after 12 weeks, after 24 weeks
QoL	Quality of life will be evaluated using the SF-36 Short Form.	Baseline, after 12 weeks, after 24 weeks
Maximal Effort Capacity	Maximal effort capacity will be evaluated using a cardiovascular stress test.	Baseline

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: 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

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: February 19, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Exercise Training; Cardiac Rehabilitation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID 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