Randomized Controlled TrialNCT04069988
Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia
A study testing Baduanjin program in people with Randomized Controlled Trial, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Baduanjin seems to be effective for improving body mass index and fasting sugar in male individuals with schizophrenia. Aim This study was to explore the effect of Baduanjin on the five metabolic parameters and body mass index in participants with chronic schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Randomized Controlled Trial
- What is being tested?
- Baduanjin program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2016to Oct 2016
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of schizophrenia
- between 20-65 years of age
- BMI ≥ 24 kg/m2 or at least one metabolic parameter abnormality
- ability to listen, speak and write Chinese
- no additional exercise beyond normal exercise.
Who cannot join
- patients in acute phase requiring hospitalization;
- patients with severe and unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia: A Randomized Controlled Trial
Baduanjin seems to be effective for improving body mass index and fasting sugar in male individuals with schizophrenia.
Aim This study was to explore the effect of Baduanjin on the five metabolic parameters and body mass index in participants with chronic schizophrenia.
Methods We recruited 92 participants from 3 chronic wards and nursing homes in eastern and northern Taiwan. Participants were assigned by blocked randomization into experimental group and control group. Those in the experimental group received 60 minutes, three times a week for 12 weeks of Baduanjin program training, while those in the control group received physical activity for thirty minutes. We collected the blood pressure, fasting blood sugar, triglyceride, high density cholesterol, waist circumference, and body mass index three times: before the intervention, end of the intervention immediately and 3-month follow up. Chi-squared and independent samples t test were used to compare the groups differences in the demographic characteristics and outcome indicators at the baseline for male and female separately. Demographic variables were controlled. Generalized Estimating Equations (GEE) were used to examine the effects of groups, time, group and time interaction by sex.
Read the detailed description
This study explored the effect of Baduanjin on metabolic parameters and body mass index in people with schizophrenia. We recruited 92 participants from 3 rehabilitation units in Taiwan. Participants were assigned by blocked randomization into an experimental group or control group. Those in the experimental group received 60 minutes of Baduanjin three times a week for 12-weeks, while those in the control group received physical activity for thirty minutes. We assessed five metabolic parameters and body mass index at three timepoints: baseline, posttest and 3-month follow up.
- Conditions
- Randomized Controlled Trial
- Being tested
- Baduanjin program
- Keywords
- Baduanjin, body mass index, metabolic parameters, metabolic syndrome, schizophrenia
- Medical subject headings
- Metabolic Syndrome, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin programBehavioural
This exercise program aimed to increase patient participation and control their metabolic parameters and body mass index through Baduanjin program. The entire program continued for 6 months (March to October 2016), and the intervention was performed for 60 min 3 times for 12-weeks; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warmup, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group (CG) received routine care and was required to physical activity for thirty minutes |
| Baduanjin program | Experimental | The entire program continued for 6 months (March to October 2016), and the intervention was performed for 60 min 3 times for 12-weeks ; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warm-up, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program. Receives: Behavioral: Baduanjin program |
What is being measured
The primary outcome is the main question the study is designed to answer.
body Mass Index
BMI is defined as Body weight(kilograms) divided by height (meter) squared
Measured: 6 months
Fasting blood sugar
Change from Baseline Fasting blood sugar (mg/dl) at 3 months and 6 months
Measured: 6 months
Waist circumference
Change from Baseline Waist circumference (inches) at 3 months and 6 months
Measured: 6 months
triglyceride
Change from Baseline triglyceride (mg/dl) at 3 months and 6 months
Measured: 6 months
Blood pressure
Change from Baseline Blood pressure (mmHg) at 3 months and 6 months
Measured: 6 months
high-density lipoprotein
Change from Baseline high-density lipoprotein (mg/dl) at 3 months and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startMar 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Randomized Controlled TrialStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were divided into experimental and control groups through block randomization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069988
- Sponsor's protocol ID
- TSGHIRB2-105-05-005
- Status last verified
- Jul 2019
- First submitted
- 25 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song MH, Liu CY, Chiou AF, Yang CY. Sex-Stratified Effects of a Baduanjin Qigong Program for People with Chronic Schizophrenia: A Multicenter Randomized Controlled Trial. J Am Psychiatr Nurses Assoc. 2026 Sep 16:10783903261485882. doi: 10.1177/10783903261485882. Online ahead of print.
PubMed 42746918
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Baduanjin on the Metabolic Parameters and Body Mass Index of People With Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04069988
- Acronym / sponsor ID
- TSGHIRB2-105-05-005
- Conditions
- Randomized Controlled Trial
- Keywords
- Baduanjin, body mass index, metabolic parameters, metabolic syndrome, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Aug 2019 (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.
Baduanjin seems to be effective for improving body mass index and fasting sugar in male individuals with schizophrenia.
Aim This study was to explore the effect of Baduanjin on the five metabolic parameters and body mass index in participants with chronic schizophrenia.
Methods We recruited 92 participants from 3 chronic wards and nursing homes in eastern and northern Taiwan. Participants were assigned by blocked randomization into experimental group and control group. Those in the experimental group received 60 minutes, three times a week for 12 weeks of Baduanjin program training, while those in the control group received physical activity for thirty minutes. We collected the blood pressure, fasting blood sugar, triglyceride, high density cholesterol, waist circumference, and body mass index three times: before the intervention, end of the intervention immediately and 3-month follow up. Chi-squared and independent samples t test were used to compare the groups differences in the demographic characteristics and outcome indicators at the baseline for male and female separately. Demographic variables were controlled. Generalized Estimating Equations (GEE) were used to examine the effects of groups, time, group and time interaction by sex.
Detailed description
This study explored the effect of Baduanjin on metabolic parameters and body mass index in people with schizophrenia. We recruited 92 participants from 3 rehabilitation units in Taiwan. Participants were assigned by blocked randomization into an experimental group or control group. Those in the experimental group received 60 minutes of Baduanjin three times a week for 12-weeks, while those in the control group received physical activity for thirty minutes. We assessed five metabolic parameters and body mass index at three timepoints: baseline, posttest and 3-month follow up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants were divided into experimental and control groups through block randomization.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group (CG) received routine care and was required to physical activity for thirty minutes |
| Baduanjin program | Experimental | Behavioral: Baduanjin programThe entire program continued for 6 months (March to October 2016), and the intervention was performed for 60 min 3 times for 12-weeks ; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warm-up, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of schizophrenia
- between 20-65 years of age
- BMI ≥ 24 kg/m2 or at least one metabolic parameter abnormality
- ability to listen, speak and write Chinese
- no additional exercise beyond normal exercise.
Key exclusion criteria (2 listed)
- patients in acute phase requiring hospitalization;
- patients with severe and unstable
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 programThis exercise program aimed to increase patient participation and control their metabolic parameters and body mass index through Baduanjin program. The entire program continued for 6 months (March to October 2016), and the intervention was performed for 60 min 3 times for 12-weeks; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warmup, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program. | Behavioural | Baduanjin program |
Primary outcome
body Mass Index
Time frame: 6 months
BMI is defined as Body weight(kilograms) divided by height (meter) squared
Fasting blood sugar
Time frame: 6 months
Change from Baseline Fasting blood sugar (mg/dl) at 3 months and 6 months
Waist circumference
Time frame: 6 months
Change from Baseline Waist circumference (inches) at 3 months and 6 months
triglyceride
Time frame: 6 months
Change from Baseline triglyceride (mg/dl) at 3 months and 6 months
Blood pressure
Time frame: 6 months
Change from Baseline Blood pressure (mmHg) at 3 months and 6 months
high-density lipoprotein
Time frame: 6 months
Change from Baseline high-density lipoprotein (mg/dl) at 3 months and 6 months
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 28 Aug 2019.
- Derived from this study: PubMed 42746918Song MH, Liu CY, Chiou AF, Yang CY. Sex-Stratified Effects of a Baduanjin Qigong Program for People with Chronic Schizophrenia: A Multicenter Randomized Controlled Trial. J Am Psychiatr Nurses Assoc. 2026 Sep 16:10783903261485882. doi: 10.1177/10783903261485882. Online ahead of print.
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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 program in people with Randomized Controlled Trial, run by National Yang Ming Chiao Tung University 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 5 inclusion and 2 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 28 Aug 2019. 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?
body Mass Index (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT04069988, which also lists 1 linked publication.
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 28 Aug 2019.