Clinical trial NCT05722366: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
active video games
aerobic exercise
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 25
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Exercise load end heart rate
timeFrame: At the 15th minute of the exercise after the warm-up.
measure: Exercise load end blood pressure
timeFrame: At the 15th minute of the exercise after the warm-up.
measure: Exercise load end perceived effort
timeFrame: At the 15th minute of the exercise after the warm-up.
measure: Exercise load end oxygen saturation
timeFrame: At the 15th minute of the exercise after the warm-up.
measure: Exercise load end shortness of breath
timeFrame: At the 15th minute of the exercise after the warm-up.
Secondary outcomes:
measure: Evaluation of energy expenditure
timeFrame: ''During exercise intervention, average 25 minutes''
measure: Evaluation of Arterial stiffness
timeFrame: Before interventions
measure: Evaluation of Arterial stiffness
timeFrame: ''First minutes'' after the intervention
measure: Baseline Blood pressure
timeFrame: Before interventions
measure: End of intervention blood pressure
timeFrame: Within the first minutes after the intervention
measure: Evaluation blood pressure
timeFrame: 5 minutes after exercises
measure: Baseline heart rate
timeFrame: Before interventions
measure: End of intervention heart rate
timeFrame: ''First minutes'' after the intervention
measure: Evaluation heart rate
timeFrame: 5 minutes after exercises
measure: Baseline perceived effort
timeFrame: Before interventions
measure: End of intervention perceived effort
timeFrame: Within the first minutes after the intervention
measure: Evaluation perceived effort
timeFrame: 5 minutes after exercises
measure: Baseline Shortness of breath
timeFrame: Before interventions
measure: End of intervention Shortness of breath
timeFrame: ''First minutes'' after the intervention
measure: Evaluation Shortness of breath
timeFrame: 5 minutes after exercises
measure: Baseline Oxygen saturation
timeFrame: Before interventions
measure: End of Oxygen saturation
timeFrame: ''First minutes'' after the intervention
measure: Evaluation Oxygen saturation
timeFrame: 5 minutes after exercises
measure: Enjoyment of interventions
timeFrame: 5 minutes after interventions
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University
state: Balcova
Study officials:
References: