## Protocol Section
### Identification Module
**NCT ID:** NCT04411979

**Brief Title:** 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

#### Organization Study ID Info
**ID:** MOST 107-2635-B-182A-002
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
#### Secondary ID Infos
**Domain:** Chang Gung Memorial Hospital
**ID:** 201702283A3C601
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2019-10-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-02

**Type:** ACTUAL

**Last Update Submit Date:** 2020-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-07-17

**Type:** ACTUAL

#### Start Date
**Date:** 2018-09-27

**Type:** ACTUAL

**Status Verified Date:** 2018-02

#### Study First Post Date
**Date:** 2020-06-02
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-22
**Study First Submit QC Date:** 2020-05-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Ministry of Science and Technology, Taiwan

#### Lead Sponsor

**Class:** OTHER

**Name:** Chang Gung Memorial Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Schizophrenia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 85

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** treatment-as-usual

**Type:** NO_INTERVENTION

#### Arm Group 2

**Intervention Names:**

- Other: treatment-as-usual plus aerobic walking

**Label:** treatment-as-usual plus aerobic walking

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- treatment-as-usual plus aerobic walking

**Description:** aerobic walking

**Name:** treatment-as-usual plus aerobic walking

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia

**Measure:** cognitive function change

**Time Frame:** week 12

**Description:** change assessment

**Measure:** treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)

**Time Frame:** week 12

#### Secondary Outcomes

**Description:** minimum value 30, maximum value 210; higher scores mean a worse outcome

**Measure:** treatment change assessed by the Positive and Negative Syndrome Scale

**Time Frame:** week 12

**Description:** change assessment

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

**Time Frame:** week 12

**Description:** change assessment

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

**Time Frame:** week 6, week 12

**Description:** change assessment

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

**Time Frame:** week 12

**Description:** change assessment

**Measure:** treatment change assessed by 6-minute walk test

**Time Frame:** week 12

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kaohsiung

**Country:** Taiwan

**Facility:** Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital

**Name:** Yu-Chi Huang, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15376

- Name: Schizophrenia

- Relevance: HIGH

- As Found: Schizophrenia

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012559

- Term: Schizophrenia

### Misc Info Module

- Version Holder: 2024-05-24
