Randomized Controlled TrialNCT04027634
Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia
A study testing Baduanjin program in people with Randomized Controlled Trial, run by National Yang Ming Chiao Tung University.
Trial summary
Introduction Low levels of physical activity and central obesity contribute to metabolic syndrome in patients with schizophrenia. Aim This study was to examine the effectiveness of Baduanjin program on body mass index (BMI) and five metabolic parameters 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2014
- 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
- People were diagnosed with schizophrenia at the age of 20-65 years.
- People had taken regular antipsychotic medication for more than 10 weeks
- People lacked regular exercise in the past 3 months.
- People consented to receive blood collection and complete a questionnaire.
- People satisfied the modified Adult Treatment Panel III criteria for Asians i.e., three abnormal results for metabolic syndrome or two abnormal results with BMI > 25)
Who cannot join
- People with organic mental disorders, alcohol dependence, and substance abuse.
- people who are not willing to sign the consent.
About this study
Official title: Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia: A Pilot Randomized Controlled Trial
Introduction Low levels of physical activity and central obesity contribute to metabolic syndrome in patients with schizophrenia.
Aim This study was to examine the effectiveness of Baduanjin program on body mass index (BMI) and five metabolic parameters in participants with chronic schizophrenia.
Methods A randomized controlled trial was conducted in a psychiatric center in northern Taiwan. The eligibility criteria included BMI > 25 kg/m2, or with metabolic syndrome. Twenty-two participants were randomized to two groups using blocked randomization. The experimental group was provided with an 8-session Baduanjin program for 12 weeks (1 h, thrice times per week), while the control group received routine care.
Read the detailed description
This study was conducted in a large psychiatric center that has 10 residential rehabilitation units. Residents were allowed to walk for 20 min during 6-7 pm every day, and each unit could accommodate approximately 50 residents. In this study, patients on the schizophrenia spectrum were invited to receive screening for metabolic syndrome. A total of 108 patients agreed to undergo the screening, and forty-seven patients were confirmed to have metabolic syndrome. Patients with metabolic syndrome or BMIs > 25 kg/m2 were invited to participate in the research. In total, sixty-two patients satisfied the inclusion criteria, and 22 patients consented to participate in the experiment.
Each participant was assigned one number from 1 to 22 by the first author. The second author enrolled participants. They were randomized to either Baduanjin program group or routine care group in a 1:1 ratio using blocked randomization having a block size of 4 by the fourth author. Patients in the experimental group (EG) participated in the Baduanjin intervention in a privacy setting", which involved 60-min sessions 3 times per week, 1 h after dinner between 6 and 7 pm; the entire program continued for 12 weeks. The control group (CG) received routine care and was required to walk during 6-7 pm. The outcome indicators for this intervention program involved the risk factors for metabolic syndrome, BW, and BMI.
When schizophrenia becomes chronic, patients experience lack of motivation. This exercise program aimed to increase patient participation and control their BW through Baduanjin program. The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; 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. While these participants practiced the Baduanjin program, the CG participants walked for 15-20 min in their wards.
- Conditions
- Randomized Controlled Trial
- Being tested
- Baduanjin program
- Keywords
- Baduanjin program, body mass index, metabolic parameters, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin programOther
This exercise program aimed to increase patient participation and control their BW through Baduanjin program. The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group (CG) received routine care and was required to walk during 6-7 pm. |
| Baduanjin program | Experimental | The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; 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: Other: Baduanjin program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Change from Baseline Body weight (kilograms) at 3 months
Measured: 3 months
body Mass Index (BMI).
BMI is defined as Body weight(kilograms) divided by height (meter) squared
Measured: 3 months
Secondary outcomes (5)
Fasting blood sugar
Change from Baseline Fasting blood sugar (mg/dl) at 3 months
Measured: 3 months
Waist circumference
Change from Baseline Waist circumference (inches) at 3 months
Measured: 3 months
triglyceride
Change from Baseline triglyceride (mg/dl) at 3 months
Measured: 3 months
Blood pressure
Change from Baseline Blood pressure (mmHg) at 3 months
Measured: 3 months
high-density lipoprotein
Change from Baseline high-density lipoprotein (mg/dl) at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Principal investigator, Chiu-Yueh Yang, National Yang Ming Chiao Tung University
- Investigators
- Chiu-Yueh Yang, Principal investigator, ICMJE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027634
- Sponsor's protocol ID
- JIRB12-S-019
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effect of Baduanjin Program for People Diagnosed With Schizophrenia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04027634
- Acronym / sponsor ID
- JIRB12-S-019
- Conditions
- Randomized Controlled Trial
- Keywords
- Baduanjin program, body mass index, metabolic parameters, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jul 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.
Introduction Low levels of physical activity and central obesity contribute to metabolic syndrome in patients with schizophrenia.
Aim This study was to examine the effectiveness of Baduanjin program on body mass index (BMI) and five metabolic parameters in participants with chronic schizophrenia.
Methods A randomized controlled trial was conducted in a psychiatric center in northern Taiwan. The eligibility criteria included BMI > 25 kg/m2, or with metabolic syndrome. Twenty-two participants were randomized to two groups using blocked randomization. The experimental group was provided with an 8-session Baduanjin program for 12 weeks (1 h, thrice times per week), while the control group received routine care.
Detailed description
This study was conducted in a large psychiatric center that has 10 residential rehabilitation units. Residents were allowed to walk for 20 min during 6-7 pm every day, and each unit could accommodate approximately 50 residents. In this study, patients on the schizophrenia spectrum were invited to receive screening for metabolic syndrome. A total of 108 patients agreed to undergo the screening, and forty-seven patients were confirmed to have metabolic syndrome. Patients with metabolic syndrome or BMIs > 25 kg/m2 were invited to participate in the research. In total, sixty-two patients satisfied the inclusion criteria, and 22 patients consented to participate in the experiment.
Each participant was assigned one number from 1 to 22 by the first author. The second author enrolled participants. They were randomized to either Baduanjin program group or routine care group in a 1:1 ratio using blocked randomization having a block size of 4 by the fourth author. Patients in the experimental group (EG) participated in the Baduanjin intervention in a privacy setting", which involved 60-min sessions 3 times per week, 1 h after dinner between 6 and 7 pm; the entire program continued for 12 weeks. The control group (CG) received routine care and was required to walk during 6-7 pm. The outcome indicators for this intervention program involved the risk factors for metabolic syndrome, BW, and BMI.
When schizophrenia becomes chronic, patients experience lack of motivation. This exercise program aimed to increase patient participation and control their BW through Baduanjin program. The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; 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. While these participants practiced the Baduanjin program, the CG participants walked for 15-20 min in their wards.
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 walk during 6-7 pm. |
| Baduanjin program | Experimental | Other: Baduanjin programThe entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; 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)
- People were diagnosed with schizophrenia at the age of 20-65 years.
- People had taken regular antipsychotic medication for more than 10 weeks
- People lacked regular exercise in the past 3 months.
- People consented to receive blood collection and complete a questionnaire.
- People satisfied the modified Adult Treatment Panel III criteria for Asians i.e., three abnormal results for metabolic syndrome or two abnormal results with BMI > 25)
Key exclusion criteria (2 listed)
- People with organic mental disorders, alcohol dependence, and substance abuse.
- people who are not willing to sign the consent.
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 BW through Baduanjin program. The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; 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. | Other | Baduanjin program |
Primary outcome
Body weight
Time frame: 3 months
Change from Baseline Body weight (kilograms) at 3 months
body Mass Index (BMI).
Time frame: 3 months
BMI is defined as Body weight(kilograms) divided by height (meter) squared
5 secondary outcomes
Fasting blood sugar
Time frame: 3 months
Waist circumference
Time frame: 3 months
triglyceride
Time frame: 3 months
Blood pressure
Time frame: 3 months
high-density lipoprotein
Time frame: 3 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 22 Jul 2019.
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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.
Chiu-Yueh Yang principal investigator
ICMJE
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.
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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 weight (time frame: 3 months). The study lists 2 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 22 Jul 2019.