- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734613
Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome
March 7, 2022 updated by: Rhayun Song, Chungnam National University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
65
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
-
-
-
Daejeon, Korea, Republic of, 34885
- Chungnam National University Hospital
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- who attend regular exercise program past 6 months
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tai Chi intervention
Tai Chi exercise intervention provided twice a week for one hour for 12 weeks
|
Yang style Tai Chi 16 movements
|
|
Active Comparator: self management
self management program provided 6 sessions (one hour per session) for 12 weeks
|
health education and dietary counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 from baseline health behavior score at 3 months
|
|
Change in blood pressure
Time Frame: change from baseline blood pressure at 3 months
|
systolic and diastolic blood pressure (mmHg)
|
change from baseline blood pressure at 3 months
|
|
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 from baseline lipid profile at 3 months
|
|
Change in blood glucose
Time Frame: change from baseline blood glucose at 3 months
|
HbA1C
|
change from baseline blood glucose at 3 months
|
|
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
|
change from baseline waist circumference at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of life
Time Frame: change from baseline QOL score at 3 months
|
health related quality of life (by SF36 v.2) to calculate mental and physical components in 100 points
|
change from baseline QOL score at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rhayun Song, Chungnam National University
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)
December 10, 2020
Primary Completion (Actual)
January 28, 2022
Study Completion (Actual)
January 28, 2022
Study Registration Dates
First Submitted
January 26, 2021
First Submitted That Met QC Criteria
January 28, 2021
First Posted (Actual)
February 2, 2021
Study Record Updates
Last Update Posted (Actual)
March 9, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChungnamNU2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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