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

Coronary Artery Disease Clinical Trial

Official title:

Comparison of Acute Responses of Aerobic Exercise and Active Video Games in Coronary Artery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05722366
• Other study ID #: DokuzEU-CAD-001
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 1, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Active video game
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.
• aerobic exercise
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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylül University	Izmir	Balcova

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the 15th minute of the exercise after the warm-up.
Primary	Exercise load end blood pressure	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.
Primary	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.	At the 15th minute of the exercise after the warm-up.
Primary	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.	At the 15th minute of the exercise after the warm-up.
Primary	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.	At the 15th minute of the exercise after the warm-up.
Secondary	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.	''During exercise intervention, average 25 minutes''
Secondary	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.	Before interventions
Secondary	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.	''First minutes'' after the intervention
Secondary	Baseline Blood pressure	Systolic and diastolic blood pressure will be measured with a sphygmomanometer.	Before interventions
Secondary	End of intervention blood pressure	Systolic and diastolic blood pressure will be measured with a sphygmomanometer.	Within the first minutes after the intervention
Secondary	Evaluation blood pressure	Systolic and diastolic blood pressure will be measured with a sphygmomanometer.	5 minutes after exercises
Secondary	Baseline heart rate	Heart rate will be evaluated by pulse oximetry.	Before interventions
Secondary	End of intervention heart rate	Heart rate will be evaluated by pulse oximetry.	''First minutes'' after the intervention
Secondary	Evaluation heart rate	Heart rate will be evaluated by pulse oximetry.	5 minutes after exercises
Secondary	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.	Before interventions
Secondary	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.	Within the first minutes after the intervention
Secondary	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.	5 minutes after exercises
Secondary	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.	Before interventions
Secondary	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.	''First minutes'' after the intervention
Secondary	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.	5 minutes after exercises
Secondary	Baseline Oxygen saturation	Oxygen saturation will be evaluated by pulse oximetry.	Before interventions
Secondary	End of Oxygen saturation	Oxygen saturation will be evaluated by pulse oximetry.	''First minutes'' after the intervention
Secondary	Evaluation Oxygen saturation	Oxygen saturation will be evaluated by pulse oximetry.	5 minutes after exercises
Secondary	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.	5 minutes after interventions