Coronary Artery DiseaseNCT05722366
Investigation of Acute Responses of Active Video Games Practice Compared to Exercise in Coronary Artery Patients
A study testing Active video game and aerobic exercise in people with Coronary Artery Disease, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Active video game and aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with coronary artery disease
- Being clinically stable
- Becoming a volunteer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Acute Responses of Aerobic Exercise and Active Video Games in Coronary Artery Patients
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Active video game, aerobic exercise
- Keywords
- coronary artery disease, active video games, aerobic exercise
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active video gameOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Video Game İntervention | Active comparator | 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. Receives: Other: Active video game |
| Aerobic Exercise Intervention | Active comparator | 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. Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the 15th minute of the exercise after the warm-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.
Measured: At the 15th minute of the exercise after the warm-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.
Measured: At the 15th minute of the exercise after the warm-up.
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.
Measured: At the 15th minute of the exercise after the warm-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.
Measured: At the 15th minute of the exercise after the warm-up.
Secondary outcomes (19)
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.
Measured: ''During exercise intervention, average 25 minutes''
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.
Measured: Before interventions
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.
Measured: ''First minutes'' after the intervention
Baseline Blood pressure
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Measured: Before interventions
End of intervention blood pressure
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Measured: Within the first minutes after the intervention
Evaluation blood pressure
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
Measured: 5 minutes after exercises
Baseline heart rate
Heart rate will be evaluated by pulse oximetry.
Measured: Before interventions
End of intervention heart rate
Heart rate will be evaluated by pulse oximetry.
Measured: ''First minutes'' after the intervention
Evaluation heart rate
Heart rate will be evaluated by pulse oximetry.
Measured: 5 minutes after exercises
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.
Measured: Before interventions
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.
Measured: Within the first minutes after the intervention
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.
Measured: 5 minutes after exercises
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.
Measured: Before interventions
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.
Measured: ''First minutes'' after the intervention
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.
Measured: 5 minutes after exercises
Baseline Oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry.
Measured: Before interventions
End of Oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry.
Measured: ''First minutes'' after the intervention
Evaluation Oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry.
Measured: 5 minutes after exercises
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.
Measured: 5 minutes after interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start20 Nov 2022
- Primary completion14 Apr 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Cörüt, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722366
- Sponsor's protocol ID
- DokuzEU-CAD-001
- Status last verified
- Sep 2023
- First submitted
- 19 Dec 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acute Responses of Aerobic Exercise and Active Video Games in Coronary Artery Patients
- ClinicalTrials.gov ID
- NCT05722366
- Acronym / sponsor ID
- DokuzEU-CAD-001
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, active video games, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Video Game İntervention | Active comparator | Other: Active video gameThe 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 | Active comparator | Other: aerobic exerciseThe 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having been diagnosed with coronary artery disease
- Being clinically stable
- Becoming a volunteer
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active video gameWith 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. | Other | Active Video Game İntervention |
| aerobic exerciseWith 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. | Other | Aerobic Exercise Intervention |
Primary outcome
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.
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.
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.
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.
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.
19 secondary outcomes
Evaluation of energy expenditure
Time frame: ''During exercise intervention, average 25 minutes''
Evaluation of Arterial stiffness
Time frame: Before interventions
Evaluation of Arterial stiffness
Time frame: ''First minutes'' after the intervention
Baseline Blood pressure
Time frame: Before interventions
End of intervention blood pressure
Time frame: Within the first minutes after the intervention
Evaluation blood pressure
Time frame: 5 minutes after exercises
Baseline heart rate
Time frame: Before interventions
End of intervention heart rate
Time frame: ''First minutes'' after the intervention
Evaluation heart rate
Time frame: 5 minutes after exercises
Baseline perceived effort
Time frame: Before interventions
End of intervention perceived effort
Time frame: Within the first minutes after the intervention
Evaluation perceived effort
Time frame: 5 minutes after exercises
Baseline Shortness of breath
Time frame: Before interventions
End of intervention Shortness of breath
Time frame: ''First minutes'' after the intervention
Evaluation Shortness of breath
Time frame: 5 minutes after exercises
Baseline Oxygen saturation
Time frame: Before interventions
End of Oxygen saturation
Time frame: ''First minutes'' after the intervention
Evaluation Oxygen saturation
Time frame: 5 minutes after exercises
Enjoyment of interventions
Time frame: 5 minutes after interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active video game and aerobic exercise in people with Coronary Artery Disease, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise load end heart rate (time frame: At the 15th minute of the exercise after the warm-up.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.