Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia (exergames)

July 5, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 80708
        • Recruiting
        • Kaohsiung Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • schizophrenia
  • aged 20-65 years

Exclusion Criteria:

  • Violence or suicidal behavior
  • Dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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"
Behavioral: playing exergames
will be provided with the "individual brain training exergames three times a week and 30 minutes each time
Other: scheduled activities
scheduled activities
Other: control group
The control group will be maintained with their scheduled activities in daycare as usual.
Other: scheduled activities
scheduled activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from MMSEat week 0, 3, 6, 9, and 12.
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.
Change from baseline behavioral intentions at week 0, 3, 6, 9, and 12.
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
Change from baseline AC sugar at week 0, 3, 6, 9, and 12.
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.
Change from baseline Positive and Negative Syndrome at week 0, 3, 6, 9, and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Chair: Yen Hsueh-Wei, Approval of Clinical Trail/Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMURCT-SV(I)-20200105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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