Clinical trial NCT04411979: Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
Official title: Cognitive Function and Energy Metabolites in Schizophrenia: the Effect of Wearable Device-assisted Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2020-06-02
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cognitive function change
timeFrame: week 12
measure: treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)
timeFrame: week 12
Secondary outcomes:
measure: treatment change assessed by the Positive and Negative Syndrome Scale
timeFrame: week 12
measure: treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)
timeFrame: week 12
measure: treatment change assessed by metabolic profiles (e.g., body weight in kilograms)
timeFrame: week 6, week 12
measure: treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)
timeFrame: week 12
measure: treatment change assessed by 6-minute walk test
timeFrame: week 12
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
name: Yu-Chi Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: