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Completed

NCT Number: NCT04734613

Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungnam National University Hospital

Daejeon, 34885, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi Exercise

Behavioral

Yang style Tai Chi 16 movements

Self Management

Behavioral

health education and dietary counseling

Primary outcomes

  1. 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

  2. Change in blood pressure

    Time frame: change from baseline blood pressure at 3 months

    systolic and diastolic blood pressure (mmHg)

  3. 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

  4. Change in blood glucose

    Time frame: change from baseline blood glucose at 3 months

    HbA1C

  5. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chungnam National University

Other

Collaborators

  • National Research Foundation, Singapore

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2021
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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