Clinical trial NCT05933356: Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia
Official title: Effectiveness of Exergames on Cognitive, Social Function and Sugar Control Among Chronic Schizophrenia Patients With Diabetes Mellitus in Taiwan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gambling
Keywords: schizophrenia
cognitive functions
social function
exergames
sugar control
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* schizophrenia
* aged 20-65 years

Exclusion Criteria:

* Violence or suicidal behavior
* Dementia

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Change from MMSEat week 0, 3, 6, 9, and 12.
measure: Behavioral intentions
timeFrame: Change from baseline behavioral intentions at week 0, 3, 6, 9, and 12.
measure: One touch' s AC sugar
timeFrame: Change from baseline AC sugar at week 0, 3, 6, 9, and 12.
measure: The Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from baseline Positive and Negative Syndrome at week 0, 3, 6, 9, and 12.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Approval of Clinical Trail/Research
name: Yen Hsueh-Wei
role: STUDY_CHAIR
References: