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

Primary Purpose

Coronary Artery Disease, Physical Inactivity

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapist supervised exercise training
Exercise training via phone app
Physical activity recommendations
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Cardiac Rehabilitation, Exercise Training

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Physiotherapist Supervised Exercise Training Group

Exercise Training Tracking from Phone-app Group

Control Group

Arm Description

Physiotherapist supervised exercise training in patients with coronary artery disease

Exercise training tracking from phone app in patients with coronary artery disease

General physical activity recommendations for home

Outcomes

Primary Outcome Measures

Exercise Capacity
Exercise capacity will be evaluated using the incremental shuttle walk test.
Participation
Participation will be evaluated using the number of sessions attended.

Secondary Outcome Measures

Maximal Effort Capacity
Maximal effort capacity will be evaluated using a cardiovascular stress test.
Peripheral muscle strength
Peripheral muscle strength will be evaluated using the dynamometer.
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.
Healthy Living Habit Evaluation
Healthy living habit evaluation will be evaluated using the Healthy Lifestyle Behaviors Scale-II.
Health-Related Quality of Life
Health-Related Quality of Life will be evaluated using the Myocardial Infarction Dimensional Assessment Scale (MIDAS).
QoL
Quality of life will be evaluated using the SF-36 Short Form.

Full Information

First Posted
February 19, 2022
Last Updated
August 16, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05264701
Brief Title
Investigation of the Effects of the Technology-based Cardiac Rehabilitation Program in Coronary Artery Patients
Official Title
Investigation of the Effects of Artificial Intelligence-supported and Technology-based Cardiac Rehabilitation Programs on Participation and Exercise Capacity in Coronary Artery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Physical Inactivity
Keywords
Cardiac Rehabilitation, Exercise Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapist Supervised Exercise Training Group
Arm Type
Experimental
Arm Description
Physiotherapist supervised exercise training in patients with coronary artery disease
Arm Title
Exercise Training Tracking from Phone-app Group
Arm Type
Experimental
Arm Description
Exercise training tracking from phone app in patients with coronary artery disease
Arm Title
Control Group
Arm Type
Experimental
Arm Description
General physical activity recommendations for home
Intervention Type
Other
Intervention Name(s)
Physiotherapist supervised exercise training
Intervention Description
Exercise training for 12 weeks will be given by video talk accompanied by a physiotherapist.
Intervention Type
Other
Intervention Name(s)
Exercise training via phone app
Intervention Description
Exercise training for 12 weeks will be given over the developed phone application.
Intervention Type
Other
Intervention Name(s)
Physical activity recommendations
Intervention Description
The program will be consist of 12 weeks of physical activity recommendations.
Primary Outcome Measure Information:
Title
Exercise Capacity
Description
Exercise capacity will be evaluated using the incremental shuttle walk test.
Time Frame
Baseline, after 12 weeks, after 24 weeks
Title
Participation
Description
Participation will be evaluated using the number of sessions attended.
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Maximal Effort Capacity
Description
Maximal effort capacity will be evaluated using a cardiovascular stress test.
Time Frame
Baseline
Title
Peripheral muscle strength
Description
Peripheral muscle strength will be evaluated using the dynamometer.
Time Frame
Baseline, after 12 weeks, after 24 weeks
Title
Endothelial function
Description
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.
Time Frame
Baseline, after 12 weeks, after 24 weeks
Title
Healthy Living Habit Evaluation
Description
Healthy living habit evaluation will be evaluated using the Healthy Lifestyle Behaviors Scale-II.
Time Frame
Baseline, after 12 weeks, after 24 weeks
Title
Health-Related Quality of Life
Description
Health-Related Quality of Life will be evaluated using the Myocardial Infarction Dimensional Assessment Scale (MIDAS).
Time Frame
Baseline, after 12 weeks, after 24 weeks
Title
QoL
Description
Quality of life will be evaluated using the SF-36 Short Form.
Time Frame
Baseline, after 12 weeks, after 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilara Saklica, MSc
Phone
+903123051576
Ext
178
Email
dilarasaklica@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naciye Vardar-Yagli, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hikmet Yorgun, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmet Hakan Ates, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Deniz Yuce, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dilara Saklica, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilara Saklica, MsC
Email
dilarasaklica@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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