Schizophrenia Clinical Trial
Official title:
Cognitive and Balance Dual Task Training for People With Schizophrenia - Program System Development and Effectiveness Analysis
Verified date | April 2024 |
Source | Kaohsiung Medical University Chung-Ho Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
After developing and pilot testing the training program, including the CogBals software, a 3-arm, single-blinded, randomized controlled trial is used to recruit 84 participants and then randomly allocated to the cognitive and balance dual task training group (COG&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.
Status | Completed |
Enrollment | 84 |
Est. completion date | September 15, 2023 |
Est. primary completion date | September 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. diagnosis of schizophrenia or schizoaffective disorder for more than 1 year by psychiatrist according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) 2. age 40-75 years old 3. have stable psychiatric symptoms currently (main psychotropic medications have not been adjusted for two months 4. being able to ambulate independently for more than 10 meters, without a walking device 5. not have significant cognitive impairment (Montreal Cognitive Assessment Taiwan Version, MoCA?20) 6. can follow study protocol and sign the informed consent form Exclusion Criteria: 1. currently in the psychiatric acute award 2. currently alcohol or drug use disorder 3. Pregnancy, head trauma and other neuromusculoskeletal injuries affect training safety and compliance 4. intellectual disability 5. Unconsciousness or confusion 6. According to the subject's self-report, those with the following medical history, including severe heart failure, myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, poor blood sugar control (i.e., renal dialysis treatment, diabetic neuropathy or retinopathy), no well-controlled hyperemia: systolic blood pressure> 160 mmHg or diastolic blood pressure> 110 mmHg 7. Currently participating in other interventional study |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Medical University | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung Medical University, Ministry of Science and Technology, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mini-Balance Evaluation System Test | score from 0-28; higher score is better | Change from baseline at 12 weeks | |
Primary | Timed up and go test under single and dual tasks | dual tasks include carrying a cup of water and calculation | Change from baseline at 12 weeks | |
Primary | Single leg stance test under single and dual tasks | dual tasks include carrying a cup of water and calculation | Change from baseline at 12 weeks | |
Primary | Chinese version of Activities-specific Balance Confidence Scale | score from 0-100; higher score is better | Change from baseline at 12 weeks | |
Primary | 6 meter walk test | Change from baseline at 12 weeks | ||
Secondary | Symbol Coding | The participant writes as many answers as possible within 90 seconds. | Change from baseline at 12 weeks | |
Secondary | Digit Span | score from 0-33; higher score is better | Change from baseline at 12 weeks | |
Secondary | Spatial Span | score from 0-32; higher score is better | Change from baseline at 12 weeks | |
Secondary | The Stroop Color and Word Test | The participant reads color words or names ink colors from different pages as quickly as possible within 45 seconds. | Change from baseline at 12 weeks | |
Secondary | Color Trials Test | Color Trials 1 and Color Trials 2 | Change from baseline at 12 weeks | |
Secondary | 30-second sit to stand test | The participant completes as many full stands as possible within 30 seconds. | Change from baseline at 12 weeks | |
Secondary | Bilateral standing heel-rise test | The participant performs the maximum number of plantar flexions possible, until the point of voluntary fatigue, as fast as possible. | Change from baseline at 12 weeks |
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