Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia

NCT ID: NCT05933356

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-05-31

Brief Summary

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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

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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

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Gambling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental group

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"

Group Type EXPERIMENTAL

playing exergames

Intervention Type BEHAVIORAL

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

scheduled activities

Intervention Type OTHER

scheduled activities

control group

The control group will be maintained with their scheduled activities in daycare as usual.

Group Type OTHER

scheduled activities

Intervention Type OTHER

scheduled activities

Interventions

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playing exergames

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

Intervention Type BEHAVIORAL

scheduled activities

scheduled activities

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* schizophrenia
* aged 20-65 years

Exclusion Criteria

* Violence or suicidal behavior
* Dementia
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yen Hsueh-Wei

Role: STUDY_CHAIR

Approval of Clinical Trail/Research

Locations

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Kaohsiung Medical University

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsiu-Fen Hsieh, PhD

Role: CONTACT

+88673121101 ext. 2626

Chen, BS

Role: CONTACT

+88673121101 ext. 6645

Facility Contacts

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Hsiu-Fen Hsieh, PhD

Role: primary

+88673121101 ext. 2626

References

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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.

Reference Type DERIVED
PMID: 41032869 (View on PubMed)

Other Identifiers

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KMURCT-SV(I)-20200105

Identifier Type: -

Identifier Source: org_study_id

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