Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411979
• Other study ID #: MOST 107-2635-B-182A-002
• Secondary ID: 201702283A3C601
• Status: Completed
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: October 15, 2019

Study information

• Verified date: February 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 15, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• treatment-as-usual plus aerobic walking
aerobic walking

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function change	cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia	week 12
Primary	treatment change assessed by serum levels of energy metabolites (e.g., ß-hydroxybutyrate)	change assessment	week 12
Secondary	treatment change assessed by the Positive and Negative Syndrome Scale	minimum value 30, maximum value 210; higher scores mean a worse outcome	week 12
Secondary	treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)	change assessment	week 12
Secondary	treatment change assessed by metabolic profiles (e.g., body weight in kilograms)	change assessment	week 6, week 12
Secondary	treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)	change assessment	week 12
Secondary	treatment change assessed by 6-minute walk test	change assessment	week 12