- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722366
Investigation of Acute Responses of Active Video Games Practice Compared to Exercise in Coronary Artery Patients
Comparison of Acute Responses of Aerobic Exercise and Active Video Games in Coronary Artery Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hande CORUT, M.Sc.
- Phone Number: +905076641515
- Email: handedincel@hotmail.com
Study Locations
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Balcova
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İzmir, Balcova, Turkey, 35140
- Dokuz Eylül University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Video Game İntervention
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. |
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.
|
Active Comparator: 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,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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise load end heart rate
Time Frame: At the 15th minute of the exercise after the warm-up.
|
It will be measured with a pulse oximeter at the end of 15 minutes of exercise loading after warming up.
|
At the 15th minute of the exercise after the warm-up.
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Exercise load end blood pressure
Time Frame: At the 15th minute of the exercise after the warm-up.
|
It will be measured with a sphygmomanometer at the end of 15 minutes of exercise loading after warming up.
|
At the 15th minute of the exercise after the warm-up.
|
Exercise load end perceived effort
Time Frame: At the 15th minute of the exercise after the warm-up.
|
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.
|
At the 15th minute of the exercise after the warm-up.
|
Exercise load end oxygen saturation
Time Frame: At the 15th minute of the exercise after the warm-up.
|
Oxygen saturation will be evaluated by pulse oximetry at the end of 15 minutes of exercise loading after warming up.
|
At the 15th minute of the exercise after the warm-up.
|
Exercise load end shortness of breath
Time Frame: At the 15th minute of the exercise after the warm-up.
|
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.
|
At the 15th minute of the exercise after the warm-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of energy expenditure
Time Frame: ''During exercise intervention, average 25 minutes''
|
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.
|
''During exercise intervention, average 25 minutes''
|
Evaluation of Arterial stiffness
Time Frame: Before interventions
|
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.
|
Before interventions
|
Baseline Blood pressure
Time Frame: Before interventions
|
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
|
Before interventions
|
End of intervention blood pressure
Time Frame: Within the first minutes after the intervention
|
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
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Within the first minutes after the intervention
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Evaluation blood pressure
Time Frame: 5 minutes after exercises
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Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
|
5 minutes after exercises
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Baseline heart rate
Time Frame: Before interventions
|
Heart rate will be evaluated by pulse oximetry.
|
Before interventions
|
Evaluation heart rate
Time Frame: 5 minutes after exercises
|
Heart rate will be evaluated by pulse oximetry.
|
5 minutes after exercises
|
Baseline perceived effort
Time Frame: Before interventions
|
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.
|
Before interventions
|
End of intervention perceived effort
Time Frame: Within the first minutes after the intervention
|
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.
|
Within the first minutes after the intervention
|
Evaluation perceived effort
Time Frame: 5 minutes after exercises
|
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.
|
5 minutes after exercises
|
Baseline Shortness of breath
Time Frame: Before interventions
|
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.
|
Before interventions
|
Evaluation Shortness of breath
Time Frame: 5 minutes after exercises
|
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.
|
5 minutes after exercises
|
Baseline Oxygen saturation
Time Frame: Before interventions
|
Oxygen saturation will be evaluated by pulse oximetry.
|
Before interventions
|
Evaluation Oxygen saturation
Time Frame: 5 minutes after exercises
|
Oxygen saturation will be evaluated by pulse oximetry.
|
5 minutes after exercises
|
Enjoyment of interventions
Time Frame: 5 minutes after 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.
|
5 minutes after interventions
|
Evaluation of Arterial stiffness
Time Frame: ''First minutes'' after the intervention
|
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.
|
''First minutes'' after the intervention
|
End of intervention heart rate
Time Frame: ''First minutes'' after the intervention
|
Heart rate will be evaluated by pulse oximetry.
|
''First minutes'' after the intervention
|
End of intervention Shortness of breath
Time Frame: ''First minutes'' after the intervention
|
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.
|
''First minutes'' after the intervention
|
End of Oxygen saturation
Time Frame: ''First minutes'' after the intervention
|
Oxygen saturation will be evaluated by pulse oximetry.
|
''First minutes'' after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEU-CAD-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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