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

September 6, 2023 updated by: Hande Cörüt, Dokuz Eylul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Balcova
      • İzmir, Balcova, Turkey, 35140
        • Dokuz Eylül University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Within the first minutes after the intervention
Evaluation blood pressure
Time Frame: 5 minutes after exercises
Systolic and diastolic blood pressure will be measured with a sphygmomanometer.
5 minutes after exercises
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DokuzEU-CAD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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