Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome

Sponsor
Chungnam National University (Other)
Overall Status
Completed
CT.gov ID
NCT04734613
Collaborator
National Research Foundation, Singapore (Other)
65
1
2
13.6
4.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tai Chi exercise
  • Behavioral: self management
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized trial to assign the participants either to intervention group 1 (Tai Chi exercise) or to intervention group 2 (self management)randomized trial to assign the participants either to intervention group 1 (Tai Chi exercise) or to intervention group 2 (self management)
Masking:
Single (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
Primary Purpose:
Supportive Care
Official Title:
Tai Chi Applied Behavioral Modification Program for Individuals With Metabolic Syndrome: Randomized Study
Actual Study Start Date :
Dec 10, 2020
Actual Primary Completion Date :
Jan 28, 2022
Actual Study Completion Date :
Jan 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tai Chi intervention

Tai Chi exercise intervention provided twice a week for one hour for 12 weeks

Behavioral: Tai Chi exercise
Yang style Tai Chi 16 movements

Active Comparator: self management

self management program provided 6 sessions (one hour per session) for 12 weeks

Behavioral: self management
health education and dietary counseling

Outcome Measures

Primary Outcome Measures

  1. Change in Cardiac health behavior scale [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

  2. Change in blood pressure [change from baseline blood pressure at 3 months]

    systolic and diastolic blood pressure (mmHg)

  3. change in lipid profile [change from baseline lipid profile at 3 months]

    high density lipoprotein(HDL), low density lipoprotein(LDL), total cholesterol, triglyceride

  4. Change in blood glucose [change from baseline blood glucose at 3 months]

    HbA1C

  5. Change in abdominal obesity [change from baseline waist circumference at 3 months]

    waist circumference (in centimeters) will be measured with indicator on upper hip bone

Secondary Outcome Measures

  1. Change in quality of life [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chungnam National University Hospital Daejeon Korea, Republic of 34885

Sponsors and Collaborators

  • Chungnam National University
  • National Research Foundation, Singapore

Investigators

  • Principal Investigator: Rhayun Song, Chungnam National University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rhayun Song, Professor, Chungnam National University
ClinicalTrials.gov Identifier:
NCT04734613
Other Study ID Numbers:
  • ChungnamNU2
First Posted:
Feb 2, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022