Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia (exergames)
Primary Purpose
Gambling
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
playing exergames
scheduled activities
Sponsored by
About this trial
This is an interventional prevention trial for Gambling focused on measuring schizophrenia, cognitive functions, social function, exergames, sugar control
Eligibility Criteria
Inclusion Criteria: schizophrenia aged 20-65 years Exclusion Criteria: Violence or suicidal behavior Dementia
Sites / Locations
- Kaohsiung Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental group
control group
Arm Description
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"
The control group will be maintained with their scheduled activities in daycare as usual.
Outcomes
Primary Outcome Measures
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.
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.
One touch' s AC sugar
One touch' s AC sugar
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05933356
First Posted
May 23, 2023
Last Updated
July 5, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05933356
Brief Title
Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia
Acronym
exergames
Official Title
Effectiveness of Exergames on Cognitive, Social Function and Sugar Control Among Chronic Schizophrenia Patients With Diabetes Mellitus in Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling
Keywords
schizophrenia, cognitive functions, social function, exergames, sugar control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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"
Arm Title
control group
Arm Type
Other
Arm Description
The control group will be maintained with their scheduled activities in daycare as usual.
Intervention Type
Behavioral
Intervention Name(s)
playing exergames
Intervention Description
will be provided with the "individual brain training exergames three times a week and 30 minutes each time
Intervention Type
Other
Intervention Name(s)
scheduled activities
Intervention Description
scheduled activities
Primary Outcome Measure Information:
Title
Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
Change from MMSEat week 0, 3, 6, 9, and 12.
Title
Behavioral intentions
Description
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.
Time Frame
Change from baseline behavioral intentions at week 0, 3, 6, 9, and 12.
Title
One touch' s AC sugar
Description
One touch' s AC sugar
Time Frame
Change from baseline AC sugar at week 0, 3, 6, 9, and 12.
Title
The Positive and Negative Syndrome Scale (PANSS)
Description
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.
Time Frame
Change from baseline Positive and Negative Syndrome at week 0, 3, 6, 9, and 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
schizophrenia
aged 20-65 years
Exclusion Criteria:
Violence or suicidal behavior
Dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiu-Fen Hsieh, PhD
Phone
+88673121101
Ext
2626
Email
hsiufen96@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen, BS
Phone
+88673121101
Ext
6645
Email
irb-training@kmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen Hsueh-Wei
Organizational Affiliation
Approval of Clinical Trail/Research
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
80708
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiu-Fen Hsieh, PhD
Phone
+88673121101
Ext
2626
Email
hsiufen96@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia
We'll reach out to this number within 24 hrs