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Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia

Effectiveness of Exergames on Cognitive, Social Function and Sugar Control Among Chronic Schizophrenia Patients With Diabetes Mellitus in Taiwan

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05933356
Acronym
exergames
Enrollment
154
Registered
2023-07-06
Start date
2023-07-01
Completion date
2024-05-31
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gambling

Keywords

schizophrenia, cognitive functions, social function, exergames, sugar control

Brief 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). 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.

Interventions

BEHAVIORALplaying exergames

will be provided with the individual brain training exergames three times a week and 30 minutes each time

OTHERscheduled activities

scheduled activities

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* schizophrenia * aged 20-65 years

Exclusion criteria

* Violence or suicidal behavior * Dementia

Design outcomes

Primary

MeasureTime frameDescription
Mini-Mental State Examination (MMSE)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 intentionsChange 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 sugarChange from baseline AC sugar at week 0, 3, 6, 9, and 12.One touch' s AC sugar
The Positive and Negative Syndrome Scale (PANSS)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.

Countries

Taiwan

Contacts

Primary ContactHsiu-Fen Hsieh, PhD
hsiufen96@gmail.com+88673121101
Backup ContactChen, BS
irb-training@kmuh.org.tw+88673121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026