Schizophrenia
Conditions
Brief summary
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
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.
Interventions
OTHERtreatment-as-usual plus aerobic walking
aerobic walking
Sponsors
Ministry of Science and Technology, Taiwan
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria 2. The patient has the ability to complete the written informed consent
Exclusion criteria
1. The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder 2. The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases 3. The patient has certified as physical disability 4. The patient is pregnant or has genetic diseases or infectious conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive function change | week 12 | cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia |
| treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate) | week 12 | change assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment change assessed by metabolic profiles (e.g., body weight in kilograms) | week 6, week 12 | change assessment |
| treatment change assessed by the Positive and Negative Syndrome Scale | week 12 | minimum value 30, maximum value 210; higher scores mean a worse outcome |
| treatment change assessed by 6-minute walk test | week 12 | change assessment |
| treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8) | week 12 | change assessment |
| treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level) | week 12 | change assessment |
Countries
Taiwan
Outcome results
None listed