Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tai Chi exercise
self management
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- Chungnam National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tai Chi intervention
self management
Arm Description
Tai Chi exercise intervention provided twice a week for one hour for 12 weeks
self management program provided 6 sessions (one hour per session) for 12 weeks
Outcomes
Primary Outcome Measures
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
Change in blood pressure
systolic and diastolic blood pressure (mmHg)
change in lipid profile
high density lipoprotein(HDL), low density lipoprotein(LDL), total cholesterol, triglyceride
Change in blood glucose
HbA1C
Change in abdominal obesity
waist circumference (in centimeters) will be measured with indicator on upper hip bone
Secondary Outcome Measures
Change in quality of life
health related quality of life (by SF36 v.2) to calculate mental and physical components in 100 points
Full Information
NCT ID
NCT04734613
First Posted
January 26, 2021
Last Updated
March 7, 2022
Sponsor
Chungnam National University
Collaborators
National Research Foundation, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT04734613
Brief Title
Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome
Official Title
Tai Chi Applied Behavioral Modification Program for Individuals With Metabolic Syndrome: Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
January 28, 2022 (Actual)
Study Completion Date
January 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chungnam National University
Collaborators
National Research Foundation, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized trial to assign the participants either to intervention group 1 (Tai Chi exercise) or to intervention group 2 (self management)
Masking
Outcomes Assessor
Masking Description
blood sample will be analyzed by the lab technician without identity of the group assignment. self-reported questionnaire is also used
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi intervention
Arm Type
Experimental
Arm Description
Tai Chi exercise intervention provided twice a week for one hour for 12 weeks
Arm Title
self management
Arm Type
Active Comparator
Arm Description
self management program provided 6 sessions (one hour per session) for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi exercise
Intervention Description
Yang style Tai Chi 16 movements
Intervention Type
Behavioral
Intervention Name(s)
self management
Intervention Description
health education and dietary counseling
Primary Outcome Measure Information:
Title
Change in Cardiac health behavior scale
Description
cardiac health behaviors scale including exercise, diet, stress management, health responsibility, and smoking - 25 items in 4 point Likert scale
Time Frame
change from baseline health behavior score at 3 months
Title
Change in blood pressure
Description
systolic and diastolic blood pressure (mmHg)
Time Frame
change from baseline blood pressure at 3 months
Title
change in lipid profile
Description
high density lipoprotein(HDL), low density lipoprotein(LDL), total cholesterol, triglyceride
Time Frame
change from baseline lipid profile at 3 months
Title
Change in blood glucose
Description
HbA1C
Time Frame
change from baseline blood glucose at 3 months
Title
Change in abdominal obesity
Description
waist circumference (in centimeters) will be measured with indicator on upper hip bone
Time Frame
change from baseline waist circumference at 3 months
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
health related quality of life (by SF36 v.2) to calculate mental and physical components in 100 points
Time Frame
change from baseline QOL score at 3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhayun Song
Organizational Affiliation
Chungnam National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
34885
Country
Korea, Republic of
12. IPD Sharing Statement
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Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome
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