Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: treatment-as-usual plus aerobic walking

• Registration Number: NCT04411979
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2018-02
• Study Start: 2018-09-27
• Primary Completion: 2019-07-17
• Study Completion: 2019-10-15
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment-as-usual plus aerobic walking	treatment-as-usual plus aerobic walking	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
treatment change assessed by metabolic profiles (e.g., body weight in kilograms)	week 6, week 12	change assessment
treatment change assessed by 6-minute walk test	week 12	change assessment
treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)	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 the Positive and Negative Syndrome Scale	week 12	minimum value 30, maximum value 210; higher scores mean a worse outcome

Trial Locations

Locations (1)

Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan