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Investigation of Acute Responses of Active Video Games Practice Compared to Exercise in Coronary Artery Patients

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Active video game
aerobic exercise
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, active video games, aerobic exercise

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Having been diagnosed with coronary artery disease Being clinically stable Becoming a volunteer Exclusion Criteria: The presence of unstable angina The presence of a pacemaker The presence of cardiomyopathy The presence of a high cardiovascular risk The presence of November severe neurological, pulmonary and musculoskeletal system diseases The patient wants to quit the study

Sites / Locations

  • Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Active Video Game İntervention

Aerobic Exercise Intervention

Arm Description

The active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and a sensor. Active video games consist of Bowling, River Rush, Rally Ball and Reflex Ridge games. Participants will exercise for a total of 25 minutes with light-paced games for warm-up for the first 5 minutes, then brisk games with different body movements until the 15 minutes are complete, and light-paced games for 5 minutes to cool down. Participants will complete active video games in the same order.

The exercise intervention will consist of a continuous moderate intensity walking session on the treadmill. After the first 5 minutes of warm-up,a at 55-70% of the peak heart rate reserve(HRR)with a 15-minute walking session, and 5 minutes of cooling down total of 25 minutes of exercise will be performed.

Outcomes

Primary Outcome Measures

Exercise load end heart rate
It will be measured with a pulse oximeter at the end of 15 minutes of exercise loading after warming up.
Exercise load end blood pressure
It will be measured with a sphygmomanometer at the end of 15 minutes of exercise loading after warming up.
Exercise load end perceived effort
The degree of perceived effort will be evaluated with the modified borg scale (M.Borg 0-10)at the end of 15 minutes of exercise loading after warming up. As the modified borg score of the person increases, the perceived effort will increase.
Exercise load end oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry at the end of 15 minutes of exercise loading after warming up.
Exercise load end shortness of breath
Shortness of breath will be assessed with the modified borg scale(M.Borg 0-10) at the end of 15 minutes of exercise loading after warming up.As the modified borg score of the person increases, the perceived shortness of breath will increase.

Secondary Outcome Measures

Evaluation of energy expenditure
Energy expenditure during active video games and exercise will be evaluated using the activity monitor. The activity monitor will be attached to the upper arm. Its accelerometer measures skin temperature, galvanic skin response and heat flux, as well as energy expenditure during movement.
Evaluation of Arterial stiffness
Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. By means of a transducer, the pressure on the brachial artery will be increased (augmentation index) and carotid-femoral pulse wave velocity (pulse wave velocity) measurements will be made over the artery.
Evaluation of Arterial stiffness
Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. By means of a transducer, the pressure on the brachial artery will be increased (augmentation index) and carotid-femoral pulse wave velocity (pulse wave velocity) measurements will be made over the artery.
Baseline Blood pressure
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
End of intervention blood pressure
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Evaluation blood pressure
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Baseline heart rate
Heart rate will be evaluated by pulse oximetry.
End of intervention heart rate
Heart rate will be evaluated by pulse oximetry.
Evaluation heart rate
Heart rate will be evaluated by pulse oximetry.
Baseline perceived effort
The degree of perceived effort will be evaluated with the Modified Borg scale(M.Borg 0-10).As the modified borg score of the person increases, the perceived effort will increase.
End of intervention perceived effort
The degree of perceived effort will be evaluated with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived effort will increase.
Evaluation perceived effort
The degree of perceived effort will be evaluated with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived effort will increase.
Baseline Shortness of breath
Shortness of breath will be assessed with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived shortness of breath will increase.
End of intervention Shortness of breath
Shortness of breath will be assessed with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived shortness of breath will increase.
Evaluation Shortness of breath
Shortness of breath will be assessed with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived shortness of breath will increase.
Baseline Oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry.
End of Oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry.
Evaluation Oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry.
Enjoyment of interventions
The enjoyment received from both interventions will be evaluated according to the visual analogue scale (0-10).As the visual analog scale score increases, the person's satisfaction with the exercise increases.

Full Information

First Posted
December 19, 2022
Last Updated
September 6, 2023
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05722366
Brief Title
Investigation of Acute Responses of Active Video Games Practice Compared to Exercise in Coronary Artery Patients
Official Title
Comparison of Acute Responses of Aerobic Exercise and Active Video Games in Coronary Artery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
At least 25 volunteers with a diagnosis of coronary artery disease in the Department of Cardiology of Dokuz Eylul University and who meet the criteria for follow-up and inclusion will participate in the study. Demographic and clinical information of the participants will be questioned. Active video games and exercise sessions will be randomized to last 25 minutes. Before and after the sessions, heart rate, blood pressure, shortness of breath, oxygen saturation and arterial stiffness will be measured. In addition, energy expenditure, heart rate, perceived exertion, shortness of breath and oxygen saturation will be recorded during the sessions. At the end of the sessions, the person will be asked if they enjoy active video games.
Detailed Description
Individuals etiology, demographic information (age, gender,marital status, education,occupation),risk factors (smoking,alcohol use,exercise habit),height,weight,curriculum vitae, family history, medications used, and effort test results will be recorded. Evaluation of energy expenditure: Energy expenditure during active video games and exercise will be evaluated using the activity monitor. The activity monitor will be attached to the upper arm. Its accelerometer measures skin temperature, galvanic skin response and heat flux, as well as energy expenditure during movement. Evaluation of hemodynamic and pulmonary responses: Blood pressure: It will be measured with a sphygmomanometer. Perceived effort: The degree of perceived effort will be evaluated with the Modified Borg scale. Shortness of breath: Shortness of breath will be assessed with the Modified Borg scale. Heart rate and Oxygen saturation: It will be evaluated by pulse oximetry. Evaluation of vascular responses: Arterial stiffness will be assessed to assess vascular responses to active video games and exercise. Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. The patient's age, gender, blood pressure, height, weight, carotid-sternal notch distance between the artery, carotid-femoral artery as the distance between the entered data to the computer after increasing pressure over the brachial artery through a transducer (augmentation index) and again, carotid-femoral pulse wave velocity via the artery (pulse wave velocity) measurements will be made. The pleasure received from both interventions will be evaluated according to the visual analogue scale (0-10). Active Video Game Intervention The active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and a sensor. Active video games consist of Bowling, River Rush, Rally Ball and Reflex Ridge games. Participants will exercise for a total of 25 minutes with light-paced games for warm-up for the first 5 minutes, then brisk games with different body movements until the 15 minutes are complete, and light-paced games for 5 minutes to cool down. Participants will complete active video games in the same order. Aerobic Exercise Intervention The exercise intervention will consist of a continuous moderate-intensity walking session on the treadmill. After the first 5 minutes of warm-up, at 55-70% of the peak heart rate reserve(HRR)with a 15-minute walking session, and 5 minutes of cooling down a total of 25 minutes of exercise will be performed. Blood pressure, heart rate, oxygen saturation, dyspnea, and perceived general fatigue (Mod.Borg 0-10) of the participants will be evaluated before the interventions, at the end of the loading, after the exercise, and 5 minutes after the intervention. Before and after the sessions arterial stiffness will be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, active video games, aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Video Game İntervention
Arm Type
Active Comparator
Arm Description
The active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and a sensor. Active video games consist of Bowling, River Rush, Rally Ball and Reflex Ridge games. Participants will exercise for a total of 25 minutes with light-paced games for warm-up for the first 5 minutes, then brisk games with different body movements until the 15 minutes are complete, and light-paced games for 5 minutes to cool down. Participants will complete active video games in the same order.
Arm Title
Aerobic Exercise Intervention
Arm Type
Active Comparator
Arm Description
The exercise intervention will consist of a continuous moderate intensity walking session on the treadmill. After the first 5 minutes of warm-up,a at 55-70% of the peak heart rate reserve(HRR)with a 15-minute walking session, and 5 minutes of cooling down total of 25 minutes of exercise will be performed.
Intervention Type
Other
Intervention Name(s)
Active video game
Intervention Description
With the closed envelope method, the order in which the participants will perform active video games and aerobic exercise will be determined. It will be applied with 2 weeks between interventions.
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
With the closed envelope method, the order in which the participants will perform active video games and aerobic exercise will be determined. It will be applied with 2 weeks between interventions.
Primary Outcome Measure Information:
Title
Exercise load end heart rate
Description
It will be measured with a pulse oximeter at the end of 15 minutes of exercise loading after warming up.
Time Frame
At the 15th minute of the exercise after the warm-up.
Title
Exercise load end blood pressure
Description
It will be measured with a sphygmomanometer at the end of 15 minutes of exercise loading after warming up.
Time Frame
At the 15th minute of the exercise after the warm-up.
Title
Exercise load end perceived effort
Description
The degree of perceived effort will be evaluated with the modified borg scale (M.Borg 0-10)at the end of 15 minutes of exercise loading after warming up. As the modified borg score of the person increases, the perceived effort will increase.
Time Frame
At the 15th minute of the exercise after the warm-up.
Title
Exercise load end oxygen saturation
Description
Oxygen saturation will be evaluated by pulse oximetry at the end of 15 minutes of exercise loading after warming up.
Time Frame
At the 15th minute of the exercise after the warm-up.
Title
Exercise load end shortness of breath
Description
Shortness of breath will be assessed with the modified borg scale(M.Borg 0-10) at the end of 15 minutes of exercise loading after warming up.As the modified borg score of the person increases, the perceived shortness of breath will increase.
Time Frame
At the 15th minute of the exercise after the warm-up.
Secondary Outcome Measure Information:
Title
Evaluation of energy expenditure
Description
Energy expenditure during active video games and exercise will be evaluated using the activity monitor. The activity monitor will be attached to the upper arm. Its accelerometer measures skin temperature, galvanic skin response and heat flux, as well as energy expenditure during movement.
Time Frame
''During exercise intervention, average 25 minutes''
Title
Evaluation of Arterial stiffness
Description
Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. By means of a transducer, the pressure on the brachial artery will be increased (augmentation index) and carotid-femoral pulse wave velocity (pulse wave velocity) measurements will be made over the artery.
Time Frame
Before interventions
Title
Evaluation of Arterial stiffness
Description
Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. By means of a transducer, the pressure on the brachial artery will be increased (augmentation index) and carotid-femoral pulse wave velocity (pulse wave velocity) measurements will be made over the artery.
Time Frame
''First minutes'' after the intervention
Title
Baseline Blood pressure
Description
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Time Frame
Before interventions
Title
End of intervention blood pressure
Description
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Time Frame
Within the first minutes after the intervention
Title
Evaluation blood pressure
Description
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Time Frame
5 minutes after exercises
Title
Baseline heart rate
Description
Heart rate will be evaluated by pulse oximetry.
Time Frame
Before interventions
Title
End of intervention heart rate
Description
Heart rate will be evaluated by pulse oximetry.
Time Frame
''First minutes'' after the intervention
Title
Evaluation heart rate
Description
Heart rate will be evaluated by pulse oximetry.
Time Frame
5 minutes after exercises
Title
Baseline perceived effort
Description
The degree of perceived effort will be evaluated with the Modified Borg scale(M.Borg 0-10).As the modified borg score of the person increases, the perceived effort will increase.
Time Frame
Before interventions
Title
End of intervention perceived effort
Description
The degree of perceived effort will be evaluated with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived effort will increase.
Time Frame
Within the first minutes after the intervention
Title
Evaluation perceived effort
Description
The degree of perceived effort will be evaluated with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived effort will increase.
Time Frame
5 minutes after exercises
Title
Baseline Shortness of breath
Description
Shortness of breath will be assessed with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived shortness of breath will increase.
Time Frame
Before interventions
Title
End of intervention Shortness of breath
Description
Shortness of breath will be assessed with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived shortness of breath will increase.
Time Frame
''First minutes'' after the intervention
Title
Evaluation Shortness of breath
Description
Shortness of breath will be assessed with the Modified Borg scale(M.Borg).As the modified borg score of the person increases, the perceived shortness of breath will increase.
Time Frame
5 minutes after exercises
Title
Baseline Oxygen saturation
Description
Oxygen saturation will be evaluated by pulse oximetry.
Time Frame
Before interventions
Title
End of Oxygen saturation
Description
Oxygen saturation will be evaluated by pulse oximetry.
Time Frame
''First minutes'' after the intervention
Title
Evaluation Oxygen saturation
Description
Oxygen saturation will be evaluated by pulse oximetry.
Time Frame
5 minutes after exercises
Title
Enjoyment of interventions
Description
The enjoyment received from both interventions will be evaluated according to the visual analogue scale (0-10).As the visual analog scale score increases, the person's satisfaction with the exercise increases.
Time Frame
5 minutes after interventions

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having been diagnosed with coronary artery disease Being clinically stable Becoming a volunteer Exclusion Criteria: The presence of unstable angina The presence of a pacemaker The presence of cardiomyopathy The presence of a high cardiovascular risk The presence of November severe neurological, pulmonary and musculoskeletal system diseases The patient wants to quit the study
Facility Information:
Facility Name
Dokuz Eylül University
City
İzmir
State/Province
Balcova
ZIP/Postal Code
35140
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of Acute Responses of Active Video Games Practice Compared to Exercise in Coronary Artery Patients

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