Gaming DisorderNCT04226677
The Effects of Video Based Training and Aerobic Exercise Training in Individuals With Internet Gaming Disorder
A study testing aerobic exercise and Video based exercise in people with Gaming Disorder and Sedentary Behavior, run by Cagtay Maden at 1 site in Turkey (Türkiye).
Trial summary
In this study, video-based training, aerobic training and both training will be applied to individuals with internet gaming disorder. Addiction levels and functional performance will be evaluated before and after treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gaming Disorder, Sedentary Behavior
- What is being tested?
- aerobic exercise and Video based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2020to 5 Nov 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM V (Diagnostic and Statistical Manual of Mental Disorders, revision 5) Internet Gaming Impairment (IOOB) Diagnostic criteria: approval of five to nine items
- No communication barrier
- Playing game (smart phone,Play Station 4, Xbox, Personal Computer) at least 2 hours a day in the last year
Who cannot join
- Cigarette use over 10 packsXyear
- be using any medicine
- Be actively involved in any sport.
- Having chronic disease
- Having physical disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Video Based Training and Aerobic Exercise Training on Game Addiction Level and Functional Performance in Individuals With Internet Gaming Disorder
In this study, video-based training, aerobic training and both training will be applied to individuals with internet gaming disorder. Addiction levels and functional performance will be evaluated before and after treatment.
Read the detailed description
The aim of this study is to investigate the effect of game-based training and aerobic exercise training on game addiction level, functional performance and exercise capacity in individuals with internet play disorder. In addition, the investigators think that facilitate the transition to exercise by using game-based training in order to gain exercise habit and reduce sedentary behaviours in individuals with internet gaming disorder.
- Conditions
- Gaming Disorder, Sedentary Behavior
- Being tested
- aerobic exercise, Video based exercise, Control group
- Keywords
- gaming disorder, aerobic exercise, exergame
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
Also called Treadmill training
Treadmill training is include warming, cooling and training phase according to rating of perceived exertion for participants.
Video based exerciseOther
Also called exergame
Exergame training include virtual reality games by xbox kinect.
Control groupOther
Also called no intervention
first and last evaluations will be made
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise group | Experimental | Aerobic exercise group is received treadmill training. Receives: Other: aerobic exercise |
| Video based exercise group | Experimental | Video based exercise group is received exergame training. Receives: Other: Video based exercise |
| Control group | Experimental | Control group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)
It consists of 9 questions. The scores that can be obtained from the scale vary between 9 and 45 and the increase in the scores, especially 36 points and above, indicates the high risk of game addiction.
Measured: 2 Monthly change
The International Physical Activity Questionnaire (IPAQ)
Used to calculate weekly physical activity level and METs
Measured: 2 Monthly change
Secondary outcomes (4)
Quality of Life Assessment: Short Form-36.
Short Form-36., quality of life questionnaire will be used. This questionnaire consists of questions measuring physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitations, and mental health status. The scores that can be obtained from the scale vary between 0 and 100 and the increase in the scores indicates that the quality of life is high.
Measured: 2 Monthly change
Anxiety Scale
Beck Anxiety Scale will be used to determine the anxiety levels of individuals.The scores that can be obtained from the scale vary between 0 and 30 and the increase in the scores indicates that the anxiety is high.
Measured: 2 Monthly change
Senior Fitness Test (SFT)
It is a test with seven physical fitness test parameters. Time and length measurements are saved in these parameters.
Measured: 2 Monthly change
20m-Shuttle Run Test
It is used to assess aerobic capacity with the treadmill. The maximum oxygen consumption is saved.
Measured: 2 Monthly change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start10 May 2020
- Primary completion5 Oct 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gaming DisorderStudies 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
- Factorial
- Model description
- participants are grouped randomly, the first group is the aerobic exercise group, the second group is the video based exercise group and the third group is the combination of these.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cagtay Maden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cagtay Maden, Hasan Kalyoncu University
- Investigators
- Çağtay maden, MSc, Pt, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226677
- Sponsor's protocol ID
- 2019/111
- Status last verified
- Oct 2021
- First submitted
- 8 Jan 2020
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Video Based Training and Aerobic Exercise Training on Game Addiction Level and Functional Performance in Individuals With Internet Gaming Disorder
- ClinicalTrials.gov ID
- NCT04226677
- Acronym / sponsor ID
- 2019/111
- Conditions
- Gaming Disorder, Sedentary Behavior
- Keywords
- gaming disorder, aerobic exercise, exergame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cagtay MadenUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 13 Jan 2020 (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.
In this study, video-based training, aerobic training and both training will be applied to individuals with internet gaming disorder. Addiction levels and functional performance will be evaluated before and after treatment.
Detailed description
The aim of this study is to investigate the effect of game-based training and aerobic exercise training on game addiction level, functional performance and exercise capacity in individuals with internet play disorder. In addition, the investigators think that facilitate the transition to exercise by using game-based training in order to gain exercise habit and reduce sedentary behaviours in individuals with internet gaming disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- participants are grouped randomly, the first group is the aerobic exercise group, the second group is the video based exercise group and the third group is the combination of these.
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise group | Experimental | Other: aerobic exerciseAerobic exercise group is received treadmill training. |
| Video based exercise group | Experimental | Other: Video based exerciseVideo based exercise group is received exergame training. |
| Control group | Experimental | Other: Control groupControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM V (Diagnostic and Statistical Manual of Mental Disorders, revision 5) Internet Gaming Impairment (IOOB) Diagnostic criteria: approval of five to nine items
- No communication barrier
- Playing game (smart phone,Play Station 4, Xbox, Personal Computer) at least 2 hours a day in the last year
Key exclusion criteria (5 listed)
- Cigarette use over 10 packsXyear
- be using any medicine
- Be actively involved in any sport.
- Having chronic disease
- Having physical disability
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 |
|---|---|---|
| aerobic exerciseAlso: Treadmill trainingTreadmill training is include warming, cooling and training phase according to rating of perceived exertion for participants. | Other | aerobic exercise group |
| Video based exerciseAlso: exergameExergame training include virtual reality games by xbox kinect. | Other | Video based exercise group |
| Control groupAlso: no interventionfirst and last evaluations will be made | Other | Control group |
Primary outcome
Internet Gaming Disorder Scale-Short-Form (IGDS9-SF)
Time frame: 2 Monthly change
It consists of 9 questions. The scores that can be obtained from the scale vary between 9 and 45 and the increase in the scores, especially 36 points and above, indicates the high risk of game addiction.
The International Physical Activity Questionnaire (IPAQ)
Time frame: 2 Monthly change
Used to calculate weekly physical activity level and METs
4 secondary outcomes
Quality of Life Assessment: Short Form-36.
Time frame: 2 Monthly change
Anxiety Scale
Time frame: 2 Monthly change
Senior Fitness Test (SFT)
Time frame: 2 Monthly change
20m-Shuttle Run Test
Time frame: 2 Monthly change
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 28 Oct 2021.
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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.
Çağtay maden, MSc, Pt principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and Video based exercise in people with Gaming Disorder and Sedentary Behavior, run by Cagtay Maden 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 5 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 28 Oct 2021. 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?
Internet Gaming Disorder Scale-Short-Form (IGDS9-SF) (time frame: 2 Monthly change). The study lists 2 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 28 Oct 2021.