Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia

Study Overview
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Brief Summary
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This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the treatment response to clarify the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function and energy metabolites in schizophrenia.

Detailed Description
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This 12-week randomized-controlled clinical trial will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. The wearable watch will be used during the participants join the walking programs. We will measure the treatment response to investigate the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function in schizophrenia.

Official Title
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Cognitive Function and Energy Metabolites in Schizophrenia: the Effect of Wearable Device-assisted Walking

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: treatment-as-usual plus aerobic walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria The patient has the ability to complete the written informed consent Exclusion Criteria: The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases The patient has certified as physical disability The patient is pregnant or has genetic diseases or infectious conditions

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: treatment-as-usual<br> | |
| Experimental: treatment-as-usual plus aerobic walking<br> | Other: treatment-as-usual plus aerobic walking<br>* aerobic walking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function change | cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia | week 12 | 
| treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate) | change assessment | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment change assessed by the Positive and Negative Syndrome Scale | minimum value 30, maximum value 210; higher scores mean a worse outcome | week 12 | 
| treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level) | change assessment | week 12 | 
| treatment change assessed by metabolic profiles (e.g., body weight in kilograms) | change assessment | week 6, week 12 | 
| treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8) | change assessment | week 12 | 
| treatment change assessed by 6-minute walk test | change assessment | week 12 |