Metabolic SyndromeNCT04734613
Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome
A study testing Tai Chi exercise and self management in people with Metabolic Syndrome, run by Chungnam National University at 1 site in South Korea.
Trial summary
This is the randomized trial to explore the effect of behavioral modification program (Tai Chi vs. self management) on adults with metabolic syndrome. The outcome variables include health behavior, metabolic syndrome indicators, quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Tai Chi exercise and self management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Dec 2020to 28 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of metabolic syndrome
- adults who agree to participate either behavioral modification programs for 12 weeks
- be able to understand the questionnaire and follow the exercise or education program
Who cannot join
- who attend regular exercise program past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tai Chi Applied Behavioral Modification Program for Individuals With Metabolic Syndrome: Randomized Study
This is the randomized trial to explore the effect of behavioral modification program (Tai Chi vs. self management) on adults with metabolic syndrome. The outcome variables include health behavior, metabolic syndrome indicators, quality of life.
Read the detailed description
- venue: the individuals with diagnosis of metabolic syndrome are recruiting from university hospital outpatient clinic or primary clinic.
- inclusion criteria: diagnosed of metabolic syndrome, agree to participate either programs, no history of participating regular exercise program past 6 months.
- intervention: The behavioral modification program consisting of Tai Chi exercise (twice a week for 12 weeks) and self-management program (6 sessions every two weeks) is provided to the participants who randomly assigned to either group. Short form Yang style Tai Chi (16 movements) were led by trained Tai Chi practitioners, and self-management program were provided by nurse educators.
- Conditions
- Metabolic Syndrome
- Being tested
- Tai Chi exercise, self management
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi exerciseBehavioural
Yang style Tai Chi 16 movements
self managementBehavioural
health education and dietary counseling
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi intervention | Experimental | Tai Chi exercise intervention provided twice a week for one hour for 12 weeks Receives: Behavioral: Tai Chi exercise |
| self management | Active comparator | self management program provided 6 sessions (one hour per session) for 12 weeks Receives: Behavioral: self management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiac health behavior scale
cardiac health behaviors scale including exercise, diet, stress management, health responsibility, and smoking - 25 items in 4 point Likert scale
Measured: change from baseline health behavior score at 3 months
Change in blood pressure
systolic and diastolic blood pressure (mmHg)
Measured: change from baseline blood pressure at 3 months
change in lipid profile
high density lipoprotein(HDL), low density lipoprotein(LDL), total cholesterol, triglyceride
Measured: change from baseline lipid profile at 3 months
Change in blood glucose
HbA1C
Measured: change from baseline blood glucose at 3 months
Change in abdominal obesity
waist circumference (in centimeters) will be measured with indicator on upper hip bone
Measured: change from baseline waist circumference at 3 months
Secondary outcomes (1)
Change in quality of life
health related quality of life (by SF36 v.2) to calculate mental and physical components in 100 points
Measured: change from baseline QOL score at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start10 Dec 2020
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial to assign the participants either to intervention group 1 (Tai Chi exercise) or to intervention group 2 (self management)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation, Singapore
- Responsible party
- Principal investigator, Rhayun Song, Chungnam National University
- Investigators
- Rhayun Song, Principal investigator, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734613
- Sponsor's protocol ID
- ChungnamNU2
- Status last verified
- Mar 2022
- First submitted
- 26 Jan 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Applied Behavioral Modification Program for Individuals With Metabolic Syndrome: Randomized Study
- ClinicalTrials.gov ID
- NCT04734613
- Acronym / sponsor ID
- ChungnamNU2
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Chungnam National UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation, Singapore
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 2 Feb 2021 (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.
This is the randomized trial to explore the effect of behavioral modification program (Tai Chi vs. self management) on adults with metabolic syndrome. The outcome variables include health behavior, metabolic syndrome indicators, quality of life.
Detailed description
- venue: the individuals with diagnosis of metabolic syndrome are recruiting from university hospital outpatient clinic or primary clinic.
- inclusion criteria: diagnosed of metabolic syndrome, agree to participate either programs, no history of participating regular exercise program past 6 months.
- intervention: The behavioral modification program consisting of Tai Chi exercise (twice a week for 12 weeks) and self-management program (6 sessions every two weeks) is provided to the participants who randomly assigned to either group. Short form Yang style Tai Chi (16 movements) were led by trained Tai Chi practitioners, and self-management program were provided by nurse educators.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized trial to assign the participants either to intervention group 1 (Tai Chi exercise) or to intervention group 2 (self management)
| Arm | Type | Receives |
|---|---|---|
| Tai Chi intervention | Experimental | Behavioral: Tai Chi exerciseTai Chi exercise intervention provided twice a week for one hour for 12 weeks |
| self management | Active comparator | Behavioral: self managementself management program provided 6 sessions (one hour per session) for 12 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of metabolic syndrome
- adults who agree to participate either behavioral modification programs for 12 weeks
- be able to understand the questionnaire and follow the exercise or education program
Key exclusion criteria (1 listed)
- who attend regular exercise program past 6 months
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 |
|---|---|---|
| Tai Chi exerciseYang style Tai Chi 16 movements | Behavioural | Tai Chi intervention |
| self managementhealth education and dietary counseling | Behavioural | self management |
Primary outcome
Change in Cardiac health behavior scale
Time frame: change from baseline health behavior score at 3 months
cardiac health behaviors scale including exercise, diet, stress management, health responsibility, and smoking - 25 items in 4 point Likert scale
Change in blood pressure
Time frame: change from baseline blood pressure at 3 months
systolic and diastolic blood pressure (mmHg)
change in lipid profile
Time frame: change from baseline lipid profile at 3 months
high density lipoprotein(HDL), low density lipoprotein(LDL), total cholesterol, triglyceride
Change in blood glucose
Time frame: change from baseline blood glucose at 3 months
HbA1C
Change in abdominal obesity
Time frame: change from baseline waist circumference at 3 months
waist circumference (in centimeters) will be measured with indicator on upper hip bone
1 secondary outcome
Change in quality of life
Time frame: change from baseline QOL score at 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 9 Mar 2022.
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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.
Rhayun Song principal investigator
Chungnam National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi exercise and self management in people with Metabolic Syndrome, run by Chungnam National University at 1 site in South Korea.
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 1 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 9 Mar 2022. 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 South Korea. 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 in Cardiac health behavior scale (time frame: change from baseline health behavior score at 3 months). The study lists 5 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 9 Mar 2022.