GamblingexergamesNCT05933356
Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia
A study testing playing exergames and scheduled activities in people with Gambling, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
An experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=77), and control group (n=77). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Gambling
- What is being tested?
- playing exergames and scheduled activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2023to 31 May 2024
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- schizophrenia
- aged 20-65 years
Who cannot join
- Violence or suicidal behavior
- Dementia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University
Kaohsiung City, 80708
Hsiu-Fen Hsieh, PhD, +88673121101 ext. 2626, hsiufen96@gmail.com
About this study
Official title: Effectiveness of Exergames on Cognitive, Social Function and Sugar Control Among Chronic Schizophrenia Patients With Diabetes Mellitus in Taiwan
An experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=77), and control group (n=77). Experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. The control group will be maintained with their scheduled activities in daycare as usual. Behavioral intentions, cognitive function, social function, and hand-eye coordination will be measured at 0, 3, 6, 9, 12 weeks.
Read the detailed description
In the first year, an experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=77), and control group (n=77). Experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. The control group will be maintained with their scheduled activities in daycare as usual. Behavioral intentions, cognitive function and hand-eye coordination will be measured at 0, 3, 6, 9, 12 weeks.
In the second year, the investigators continue first year study, the experimental group will be provided with the "team cooperation training exergames (a new program for improving sugar control, cognitive and social function)" three times a week and 30 minutes each time. The control group will still be maintained with their scheduled activities in daycare as usual. Cognitive and social function and related physiological indices (muscle mass, fasting blood sugar, glycosylated hemoglobin (HbA1c) and reduction body fat will be measured before intervention and at 0, 3, 6, 9, 12 weeks.
In the third year, in the first three months, the investigators will use the concept of "empowerment" to design a seed program for training 2-3 patients to be "exergame instructors". Experimental group A will be provided with the "team cooperation exergames" three times a week and 30 minutes each time by research team. Experimental group B will be provided with the "team cooperation exergames (teamwork and exercise)" three times a week and 30 minutes each time by "exergame seed ". The control group will be maintained with their scheduled activities in daycare as usual. Cognitive and social function, and related physiological indices will be measured at 0 3, 6, 9, 12 weeks.
The investigators expect this research project can improve the cognitive, social function and sugar control among chronic schizophrenia patients with diabetes mellitus, and the "exergames" can be extended.
- Conditions
- Gambling
- Being tested
- playing exergames, scheduled activities
- Keywords
- schizophrenia, cognitive functions, social function, exergames, sugar control
- Medical subject headings
- Gambling, Schizophrenia, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
playing exergamesBehavioural
will be provided with the "individual brain training exergames three times a week and 30 minutes each time
scheduled activitiesOther
scheduled activities
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time.
"Exergame" and "no intervention" are more informative than "1" and "2" Receives: Behavioral: playing exergames; Other: scheduled activities |
| control group | Other | The control group will be maintained with their scheduled activities in daycare as usual. Receives: Other: scheduled activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
Cognitive functions were conducted using the MMSE (Folstein et al., 1975). The MMSE is, in some way, the best known and most widely used measure of cognition in clinical practice worldwide. The MMSE consists of 30 questions for assessing the following seven cognitive domains: orientation in time and place, memory registration and recall, attention and calculation, and language. The total MMSE score ranged from 0 to 30, and higher scores indicate better cognitive functions.
Measured: Change from MMSEat week 0, 3, 6, 9, and 12.
Behavioral intentions
We measured participants' behavioral intention to play exergames using a questionnaire on the behavioral intention, which consisted of four items, and each item used a 5-point Likert scale to assess the levels of agreement with each statement. The contents of this questionnaire were as follows: "In your opinion, will you play and try different exergames in the future? Do you think that exergames can make you relaxed or vigorous?" The total score for the four items ranged from 0 to 16. Higher scores indicate a stronger intention to play exergames. The test-retest (two weeks) intraclass correlation coefficient was 0.88.
Measured: Change from baseline behavioral intentions at week 0, 3, 6, 9, and 12.
One touch' s AC sugar
One touch' s AC sugar
Measured: Change from baseline AC sugar at week 0, 3, 6, 9, and 12.
The Positive and Negative Syndrome Scale (PANSS)
The PANSS is among the best-validated instrument for assessing positive, negative, and general psychopathology symptoms associated with schizophrenic patients. It is a standardised clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology symptoms (e.g., anxiety, depression, etc.) within the past week for schizophrenic patients.
Measured: Change from baseline Positive and Negative Syndrome at week 0, 3, 6, 9, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GamblingStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. The control group will be maintained with their scheduled activities in daycare as usual.
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen Hsueh-Wei, Study chair, Approval of Clinical Trail/Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933356
- Sponsor's protocol ID
- KMURCT-SV(I)-20200105
- Acronym
- exergames
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen HH, Lin CC, Yu ML, Wu HL, Shen HC, Hsieh HF. Active Video Games to Improve Behavioral Intentions and Cognitive Function in Patients With Schizophrenia: Randomized Controlled Trial. JMIR Serious Games. 2025 Oct 1;13:e69116. doi: 10.2196/69116.
PubMed 41032869
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exergames on Cognitive, Social Function and Sugar Control Among Chronic Schizophrenia Patients With Diabetes Mellitus in Taiwan
- ClinicalTrials.gov ID
- NCT05933356
- Acronym / sponsor ID
- exergames / KMURCT-SV(I)-20200105
- Conditions
- Gambling
- Keywords
- schizophrenia, cognitive functions, social function, exergames, sugar control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 6 Jul 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.
An experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=77), and control group (n=77). Experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. The control group will be maintained with their scheduled activities in daycare as usual. Behavioral intentions, cognitive function, social function, and hand-eye coordination will be measured at 0, 3, 6, 9, 12 weeks.
Detailed description
In the first year, an experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=77), and control group (n=77). Experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. The control group will be maintained with their scheduled activities in daycare as usual. Behavioral intentions, cognitive function and hand-eye coordination will be measured at 0, 3, 6, 9, 12 weeks.
In the second year, the investigators continue first year study, the experimental group will be provided with the "team cooperation training exergames (a new program for improving sugar control, cognitive and social function)" three times a week and 30 minutes each time. The control group will still be maintained with their scheduled activities in daycare as usual. Cognitive and social function and related physiological indices (muscle mass, fasting blood sugar, glycosylated hemoglobin (HbA1c) and reduction body fat will be measured before intervention and at 0, 3, 6, 9, 12 weeks.
In the third year, in the first three months, the investigators will use the concept of "empowerment" to design a seed program for training 2-3 patients to be "exergame instructors". Experimental group A will be provided with the "team cooperation exergames" three times a week and 30 minutes each time by research team. Experimental group B will be provided with the "team cooperation exergames (teamwork and exercise)" three times a week and 30 minutes each time by "exergame seed ". The control group will be maintained with their scheduled activities in daycare as usual. Cognitive and social function, and related physiological indices will be measured at 0 3, 6, 9, 12 weeks.
The investigators expect this research project can improve the cognitive, social function and sugar control among chronic schizophrenia patients with diabetes mellitus, and the "exergames" can be extended.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. The control group will be maintained with their scheduled activities in daycare as usual.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: playing exergames, Other: scheduled activitiesThe experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. "Exergame" and "no intervention" are more informative than "1" and "2" |
| control group | Other | Other: scheduled activitiesThe control group will be maintained with their scheduled activities in daycare as usual. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- schizophrenia
- aged 20-65 years
Key exclusion criteria (2 listed)
- Violence or suicidal behavior
- Dementia
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 |
|---|---|---|
| playing exergameswill be provided with the "individual brain training exergames three times a week and 30 minutes each time | Behavioural | Experimental group |
| scheduled activitiesscheduled activities | Other | Experimental group, control group |
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: Change from MMSEat week 0, 3, 6, 9, and 12.
Cognitive functions were conducted using the MMSE (Folstein et al., 1975). The MMSE is, in some way, the best known and most widely used measure of cognition in clinical practice worldwide. The MMSE consists of 30 questions for assessing the following seven cognitive domains: orientation in time and place, memory registration and recall, attention and calculation, and language. The total MMSE score ranged from 0 to 30, and higher scores indicate better cognitive functions.
Behavioral intentions
Time frame: Change from baseline behavioral intentions at week 0, 3, 6, 9, and 12.
We measured participants' behavioral intention to play exergames using a questionnaire on the behavioral intention, which consisted of four items, and each item used a 5-point Likert scale to assess the levels of agreement with each statement. The contents of this questionnaire were as follows: "In your opinion, will you play and try different exergames in the future? Do you think that exergames can make you relaxed or vigorous?" The total score for the four items ranged from 0 to 16. Higher scores indicate a stronger intention to play exergames. The test-retest (two weeks) intraclass correlation coefficient was 0.88.
One touch' s AC sugar
Time frame: Change from baseline AC sugar at week 0, 3, 6, 9, and 12.
One touch' s AC sugar
The Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline Positive and Negative Syndrome at week 0, 3, 6, 9, and 12.
The PANSS is among the best-validated instrument for assessing positive, negative, and general psychopathology symptoms associated with schizophrenic patients. It is a standardised clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology symptoms (e.g., anxiety, depression, etc.) within the past week for schizophrenic patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 41032869Chen HH, Lin CC, Yu ML, Wu HL, Shen HC, Hsieh HF. Active Video Games to Improve Behavioral Intentions and Cognitive Function in Patients With Schizophrenia: Randomized Controlled Trial. JMIR Serious Games. 2025 Oct 1;13:e69116. doi: 10.2196/69116.
- 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.
Yen Hsueh-Wei study chair
Approval of Clinical Trail/Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing playing exergames and scheduled activities in people with Gambling, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jul 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiu-Fen Hsieh, PhD (+88673121101 ext. 2626, hsiufen96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: Change from MMSEat week 0, 3, 6, 9, and 12.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933356, which also lists 1 linked publication.
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 6 Jul 2023.