Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Tai Chi Applied Behavioral Modification Program for Individuals With Metabolic Syndrome: Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734613
• Other study ID #: ChungnamNU2
• Status: Completed
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: January 28, 2022

Study information

• Verified date: March 2022
• Source: Chungnam National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

1. venue: the individuals with diagnosis of metabolic syndrome are recruiting from university hospital outpatient clinic or primary clinic.

2. inclusion criteria: diagnosed of metabolic syndrome, agree to participate either programs, no history of participating regular exercise program past 6 months.

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• Tai Chi exercise
Yang style Tai Chi 16 movements
• self management
health education and dietary counseling

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (2)

Lead Sponsor	Collaborator
Chungnam National University	National Research Foundation, Singapore

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from baseline health behavior score at 3 months
Primary	Change in blood pressure	systolic and diastolic blood pressure (mmHg)	change from baseline blood pressure at 3 months
Primary	change in lipid profile	high density lipoprotein(HDL), low density lipoprotein(LDL), total cholesterol, triglyceride	change from baseline lipid profile at 3 months
Primary	Change in blood glucose	HbA1C	change from baseline blood glucose at 3 months
Primary	Change in abdominal obesity	waist circumference (in centimeters) will be measured with indicator on upper hip bone	change from baseline waist circumference at 3 months
Secondary	Change in quality of life	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