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

Detailed 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.

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.

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

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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