Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia

NCT05933356 | Unknown

• 1 other identifier: KMURCT-SV(I)-20200105
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Gambling

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Change from baseline behavioral intentions at week 0, 3, 6, 9, and 12.

• One touch' s AC sugar

  One touch' s AC sugar

  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.

  Change from baseline Positive and Negative Syndrome at week 0, 3, 6, 9, and 12.

Study Arms (2)

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"

Behavioral: playing exergames; Other: scheduled activities

control group

OTHER

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

Other: scheduled activities

Interventions

playing exergames BEHAVIORAL

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

Experimental group

scheduled activities OTHER

scheduled activities

Experimental group; control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• schizophrenia
• aged 20-65 years

You may not qualify if:

• Violence or suicidal behavior
• Dementia

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 80708, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 41032869 DERIVED

MeSH Terms

Conditions

Gambling; Schizophrenia; Social Adjustment

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Social Behavior

Study Officials

• Yen Hsueh-Wei

  Approval of Clinical Trail/Research

  STUDY CHAIR

Central Study Contacts

Hsiu-Fen Hsieh, PhD

CONTACT

+88673121101; hsiufen96@gmail.com

Chen, BS

CONTACT

+88673121101; irb-training@kmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 6, 2023
• Study Start: July 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 31, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)