SchizophreniaNCT04430309
Baduanjin on Patients With Schizophrenia
A study testing Baduanjin exercise program and Brisk walking program in people with Schizophrenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Baduanjin exercise program and Brisk walking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Apr 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital, Kaohsiung Medical Center
Kaohsiung City, 833
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Baduanjin exercise program, Brisk walking program
- Keywords
- Schizophrenia, mind body intervention ,Baduanjin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exercise programBehavioural
Also called Eight Silken Movements, Eight Silk Weaving
The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.
Brisk walking programBehavioural
The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin exercise group | Experimental | 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 Receives: Behavioral: Baduanjin exercise program |
| Control group | Active comparator | 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 Receives: Behavioral: Brisk walking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of 6-minute walk test
This test evaluates cardiovascular fitness and walking speed.
Measured: Baseline, immediate after treatment, 4-week follow up
Change scores of 30-second chair stand test
This test evaluates muscular endurance of lower-extremities.
Measured: Baseline, immediate after treatment, 4-week follow up
Change scores of Timed up-and-go test
This test evaluates functional mobility, agility and balance
Measured: Baseline, immediate after treatment, 4-week follow up
Change scores of Montreal cognitive assessment
This test evaluates global cognition.
Measured: Baseline, immediate after treatment, 4-week follow up
Change scores of Trail making test (part A and part B)
This test evaluates speed of processing, visual attention and cognitive flexibility.
Measured: Baseline, immediate after treatment, 4-week follow up
Change scores of Logical Memory
It is a subtest of the Wechsler Memory Scale. This test evaluates memory.
Measured: Baseline, immediate after treatment, 4-week follow up
Secondary outcomes (3)
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.
Measured: 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.
Measured: Baseline, immediate after treatment, 4-week follow up
Change scores of Activities of Daily Living Rating Scale III
It is a self-administered, paper-and-pencil test that evaluates daily functions
Measured: Baseline, immediate after treatment, 4-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start10 Apr 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430309
- Sponsor's protocol ID
- 202000817B0
- Status last verified
- May 2025
- First submitted
- 3 Jun 2020
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04430309
- Acronym / sponsor ID
- 202000817B0
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, mind body intervention ,Baduanjin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin exercise group | Experimental | Behavioral: Baduanjin exercise programThe 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 |
| Control group | Active comparator | Behavioral: Brisk walking programThe 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin exercise programAlso: Eight Silken Movements, Eight Silk WeavingThe sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down. | Behavioural | Baduanjin exercise group |
| Brisk walking programThe sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down. | Behavioural | Control group |
Primary outcome
Change scores of 6-minute walk test
Time frame: Baseline, immediate after treatment, 4-week follow up
This test evaluates cardiovascular fitness and walking speed.
Change scores of 30-second chair stand test
Time frame: Baseline, immediate after treatment, 4-week follow up
This test evaluates muscular endurance of lower-extremities.
Change scores of Timed up-and-go test
Time frame: Baseline, immediate after treatment, 4-week follow up
This test evaluates functional mobility, agility and balance
Change scores of Montreal cognitive assessment
Time frame: Baseline, immediate after treatment, 4-week follow up
This test evaluates global cognition.
Change scores of Trail making test (part A and part B)
Time frame: Baseline, immediate after treatment, 4-week follow up
This test evaluates speed of processing, visual attention and cognitive flexibility.
Change scores of Logical Memory
Time frame: Baseline, immediate after treatment, 4-week follow up
It is a subtest of the Wechsler Memory Scale. This test evaluates memory.
3 secondary outcomes
Change scores of dual task Timed up-and-go test (manual)
Time frame: Baseline, immediate after treatment, 4-week follow up
Change scores of dual task Timed up-and-go test (cognitive)
Time frame: Baseline, immediate after treatment, 4-week follow up
Change scores of Activities of Daily Living Rating Scale III
Time frame: Baseline, immediate after treatment, 4-week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercise program and Brisk walking program in people with Schizophrenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of 6-minute walk test (time frame: Baseline, immediate after treatment, 4-week follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.