NCT06226779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

July 29, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

January 18, 2024

Last Update Submit

July 24, 2025

Conditions

Keywords

schizophrenia, mindful exercise, exercise, cognition

Outcome Measures

Primary Outcomes (6)

  • Change score of the Brief Assessment of Cognition in Schizophrenia (BACS)

    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.

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of 6-minute walk test

    This test evaluates cardiovascular fitness and walking speed.

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of 30-second chair stand test

    This test evaluates muscular endurance of lower-extremities.

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of Timed up-and-go test

    This test evaluates functional mobility, agility and balance

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of dual task Timed up-and-go test (manual)

    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.

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of dual task Timed up-and-go test (cognitive)

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

    Baseline, immediate after treatment, 4-week follow up

Secondary Outcomes (2)

  • Change score of Depression, Anxiety Stress Scales-21 (DASS-21)

    Baseline, immediate after treatment, 4-week follow up

  • Change score of Pittsburg Sleep Quality Index

    Baseline, immediate after treatment, 4-week follow up

Study Arms (3)

Baduanjin

EXPERIMENTAL

Parcipants will practice baduanjin exercise.

Behavioral: Baduanjin exercsie

Brisk walking

ACTIVE COMPARATOR

Parcipants will perform brisk walking activities.

Behavioral: Brisk walking

health education

OTHER

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

Behavioral: Health education

Interventions

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.

Also known as: Mindful baduanjin
Baduanjin
Brisk walkingBEHAVIORAL

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.

Also known as: aerobic walking
Brisk walking

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

Also known as: video watching
health education

Eligibility Criteria

Age20 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital, Kaohsiung Medical Center

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaMotor ActivityDisease

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chen Chyi-Rong, Master

    Chang gung memorial hospital, Kaohsiung branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational therapist

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 26, 2024

Study Start

January 16, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

July 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations