## Protocol Section
### Identification Module
**NCT ID:** NCT06226779

**Brief Title:** Baduanjin Versus Brisk Walking for Cognition in Schizophrenia

**Official Title:** Mindful Exercise Baduanjin Versus Brisk Walking for Cognitive Function in Patients With Schizophrenia

#### Organization Study ID Info
**ID:** 202400006B0
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2025-02-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-26

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-18

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-16

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-01-26
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-18
**Study First Submit QC Date:** 2024-01-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chang Gung Memorial Hospital

#### Responsible Party

**Investigator Affiliation:** Chang Gung Memorial Hospital

**Investigator Full Name:** Chen Chyi-Rong

**Investigator Title:** Occupational therapist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The current study intends to recruit participants with schizophrenia for the practice of Baduanjin, brisk walking, and health education after enrollment. The study also including a maintenance program. Cognitive and physical function assessments will be conducted before, after, and during follow-up tests. The research hypothesis posits that both Baduanjin and brisk walking will confer beneficial effects on various aspects of cognitive and physical functions.

**Detailed Description:** Cognitive function deficits are core features in patients with schizophrenia. These deficits need active intervention to prevent functional decline. Baduanjin and brisk walking show promise as interventions in patients with schizophrenia. This study investigated the effects of Baduanjin exercise versus brisk walking in patients with schizophrenia.

This study will be a single-blind, 3-arm, parallel, randomized controlled trial.

A total of 120 patients with schizophrenia will be enrolled and randomly assigned to the Baduanjin group, brisk walking group or control group. The intervention group will practice Badunjin exercise. While participants in brisk walking group will receive brisk walking at the same duration. The controls will watch videos that are not aimed at improving physical exertion. Maintenance programs will also be conducted for participants to encourage practicing in exercise after intervention. All group will undergo evaluation at three time points: baseline, immediately after intervention and 4-week follow up after intervention. The primary outcome will be cognitive function and physical function. Secondary outcomes will include mood, sleep quality, and quality of live.

### Conditions Module

**Conditions:**

- Schizophrenia

- Exercise

- Condition

**Keywords:**

- schizophrenia, mindful exercise, exercise, cognition

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Parcipants will practice baduanjin exercise.

**Intervention Names:**

- Behavioral: Baduanjin exercsie

**Label:** Baduanjin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Parcipants will perform brisk walking activities.

**Intervention Names:**

- Behavioral: Brisk walking

**Label:** Brisk walking

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Parcipants will receive health education classes and watch sport related videos.

**Intervention Names:**

- Behavioral: Health education

**Label:** health education

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Baduanjin

**Description:** The Baduanjin exercise consists of 8 postures, with emphasis on different body parts. The exercise is commonly practiced as follows: (1) 2 hands holding up the heavens, (2) drawing the bow to shoot the eagle, (3) separating the heaven and earth, (4) wise owl gazing backwards, (5) swaying the head and shaking the tail, (6) 2 hands holding the feet to strengthen the waist, (7) clenching the fists and glaring fiercely, and (8) bouncing on the toes.

**Name:** Baduanjin exercsie

**Other Names:**

- Mindful baduanjin

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Brisk walking

**Description:** The brisk walking will be gradually increased physical exertion from light to moderate of intensity. During the training period, the heart rate of participants will be monitored.

**Name:** Brisk walking

**Other Names:**

- aerobic walking

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- health education

**Description:** Health education will include lecture classes. Video watching will watch videos which were not aim at improving physical exertion, such as sports games or sports related variety shows

**Name:** Health education

**Other Names:**

- video watching

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** BACS is a battery of cognition tests that measure verbal memory, working memory, motor speed, verbal fluency, attention and processing speed, and executive function.The BACS is comprised of seven subtests: (1) the List Learning Test, (2) Digit Sequencing Test, (3) Token Motor Test, (4) Category Instance Test, (5) Controlled Oral Word Association Test, (6) Symbol Coding, and (7) Tower of London Test.

**Measure:** Change score of the Brief Assessment of Cognition in Schizophrenia (BACS)

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

**Description:** This test evaluates cardiovascular fitness and walking speed.

**Measure:** Change scores of 6-minute walk test

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

**Description:** This test evaluates muscular endurance of lower-extremities.

**Measure:** Change scores of 30-second chair stand test

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

**Description:** This test evaluates functional mobility, agility and balance

**Measure:** Change scores of Timed up-and-go test

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

**Description:** This test requires carry a cup of water 3 cm from the top of the cup while performing the Timed up-and-go test. It evaluates dual task performance.

**Measure:** Change scores of dual task Timed up-and-go test (manual)

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

**Description:** This test combine serial three counting and Timed up-and-go test simultaneously. It evaluates dual task performance.

**Measure:** Change scores of dual task Timed up-and-go test (cognitive)

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

#### Secondary Outcomes

**Description:** DASS-21 is a self-report questionnaire that measure symptoms of depression, anxiety, and stress.

**Measure:** Change score of Depression, Anxiety Stress Scales-21 (DASS-21)

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

**Description:** PSQI is a self-report assessment which contains 19 items to measure sleep quality

**Measure:** Change score of Pittsburg Sleep Quality Index

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

**Description:** EQ-5D is a self-reporting questionnaire that measures five dimensions of health state: (1) mobility, (2) self-care, (3)usual activities, (4) pain/discomfort, and (5) anxiety/depression.

**Measure:** Change score of Euro-Qol 5-Dimmensions (EQ-5D).

**Time Frame:** Baseline, immediate after treatment, 4-week follow up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Having a diagnosis of schizophrenia according to the DSM-5.
2. Who will be above 20-65 years of age .
3. Having a stable mental status without shift in medication and keep in same dose for at least one month.
4. Being able to walk independently for 50 meters.

Exclusion Criteria:

1. Serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease.
2. Visual or auditory impairment that precludes completion of assessment.
3. Acute psychosis requiring hospitalization.
4. Presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions.

**Gender Based:** True

**Gender Description:** Based on self-representation of gender identity.

**Maximum Age:** 65 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ccr776@cgmh.org.tw

**Name:** Chyi-Rong Chen, Master

**Phone:** 886-7-7317123

**Phone Ext:** 8755

**Role:** CONTACT

**Contact 2:**

**Email:** kehchunglin@ntu.edu.tw

**Name:** Keh-chung Lin, Doctor

**Phone:** 886-2-33668180

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Kaohsiung

**Contacts:**

***Contact 1:***

- **Email:** ccr776@cgmh.org.tw

- **Name:** Chyi-Rong Chen, Master

- **Phone:** +886-7-7317123

- **Phone Ext:** 8755

- **Role:** CONTACT

***Contact 2:***

- **Email:** tracy5824@hotmail.com

- **Name:** Tzu-Ting Chen, Master

- **Phone:** +886-7-7317123

- **Phone Ext:** 8755

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Chang Gung Memorial Hospital, Kaohsiung Medical Center

**Status:** RECRUITING

**Zip:** 833

#### Overall Officials

**Official 1:**

**Affiliation:** Chang gung memorial hospital, Kaohsiung branch

**Name:** Chen Chyi-Rong, Master

**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
