- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430309
Baduanjin on Patients With Schizophrenia
May 25, 2025 updated by: Chang Gung Memorial Hospital
The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial
As an ancient, popular Chinese exercise, Baduanjin is characterized by symmetrical posture, deep breathing and meditation and easy to learn.
Previous studies showed immediate effect of Baduanjin on cognition in patients with schizophrenia.The purpose of this study is to investigate the immediate effect and chronic effect of Baduanjin exercise on physical fitness, cognition and daily functions in middle-aged and older adults with schizophrenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A single-blind, 2-arm randomized controlled trial investigating the benefits of Baduanjin exercise on middle-aged and older patients with schizophrenia.
A total of 48 participants will be assigned to either 12 weeks of 60-minute two sessions per week Baduanjin exercise group or a brisk walking group.
Primary outcomes are physical fitness and cognition functions.
Secondary outcomes are dual task performance and daily functions.
Evaluation will be completed at baseline, immediately after treatment and 4-week follow up.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 833
- Chang Gung Memorial Hospital, Kaohsiung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having a diagnosis of schizophrenia according to the DSM-5.
- Independent adult aged 40 years or older in the day-care center.
- Having a stable mental status without shift in medication and keep in same dose for at least one month.
Exclusion Criteria:
- 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.
- Participating in another clinical trial at the same time.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Baduanjin exercise group
The intervention group will practice Badunjin in a group which include 6-8 participants and one trained medical staff. The Baduanjin is an ancient Chinese mind-body exercise, which comprised of eight simple movements. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks |
The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.
Other Names:
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Active Comparator: Control group
The control group will receive brisk walking activities.
The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks
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The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change scores of 6-minute walk test
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test evaluates cardiovascular fitness and walking speed.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of 30-second chair stand test
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test evaluates muscular endurance of lower-extremities.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of Timed up-and-go test
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test evaluates functional mobility, agility and balance
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Baseline, immediate after treatment, 4-week follow up
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Change scores of Montreal cognitive assessment
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test evaluates global cognition.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of Trail making test (part A and part B)
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test evaluates speed of processing, visual attention and cognitive flexibility.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of Logical Memory
Time Frame: Baseline, immediate after treatment, 4-week follow up
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It is a subtest of the Wechsler Memory Scale.
This test evaluates memory.
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Baseline, immediate after treatment, 4-week follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change scores of dual task Timed up-and-go test (manual)
Time Frame: Baseline, immediate after treatment, 4-week follow up
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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.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of dual task Timed up-and-go test (cognitive)
Time Frame: Baseline, immediate after treatment, 4-week follow up
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This test combine serial three counting and Timed up-and-go test simultaneously.
It evaluates dual task performance.
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Baseline, immediate after treatment, 4-week follow up
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Change scores of Activities of Daily Living Rating Scale III
Time Frame: Baseline, immediate after treatment, 4-week follow up
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It is a self-administered, paper-and-pencil test that evaluates daily functions
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Baseline, immediate after treatment, 4-week follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
June 3, 2020
First Submitted That Met QC Criteria
June 10, 2020
First Posted (Actual)
June 12, 2020
Study Record Updates
Last Update Posted (Actual)
May 30, 2025
Last Update Submitted That Met QC Criteria
May 25, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202000817B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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