Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia

NCT04411979 | Completed

• 2 other identifiers: MOST 107-2635-B-182A-002201702283A3C601
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• treatment change assessed by the Positive and Negative Syndrome Scale

  week 12

• treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)

  week 12

• treatment change assessed by metabolic profiles (e.g., body weight in kilograms)

  week 6, week 12

• treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)

  week 12

• treatment change assessed by 6-minute walk test

  week 12

Study Arms (2)

treatment-as-usual

NO INTERVENTION

treatment-as-usual plus aerobic walking

EXPERIMENTAL

Other: treatment-as-usual plus aerobic walking

Interventions

treatment-as-usual plus aerobic walking OTHER

aerobic walking

treatment-as-usual plus aerobic walking

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Yu-Chi Huang, MD

  Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 2, 2020
• Study Start: September 27, 2018
• Primary Completion: July 17, 2019
• Study Completion: October 15, 2019
• Last Updated: June 2, 2020

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)