Tai Chi for Behavioral Modification Among Individuals With Metabolic Syndrome

NCT04734613 | Completed

• 1 other identifier: ChungnamNU2
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

• Change in blood pressure

  systolic and diastolic blood pressure (mmHg)

  change from baseline blood pressure at 3 months

• change in lipid profile

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

  change from baseline lipid profile at 3 months

• Change in blood glucose

  HbA1C

  change from baseline blood glucose at 3 months

• 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 Outcomes (1)

• Change in quality of life

  change from baseline QOL score at 3 months

Study Arms (2)

Tai Chi intervention

EXPERIMENTAL

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

Behavioral: Tai Chi exercise

self management

ACTIVE COMPARATOR

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

Behavioral: self management

Interventions

Tai Chi exercise BEHAVIORAL

Yang style Tai Chi 16 movements

Tai Chi intervention

self management BEHAVIORAL

health education and dietary counseling

self management

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• who attend regular exercise program past 6 months

Sponsors & Collaborators

• Chungnam National University: lead
• National Research Foundation, Singapore: collaborator

Study Sites (1)

Chungnam National University Hospital

Daejeon, 34885, South Korea

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Aquatic Therapy; Self-Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rhayun Song

  Chungnam National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blood sample will be analyzed by the lab technician without identity of the group assignment. self-reported questionnaire is also used
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized trial to assign the participants either to intervention group 1 (Tai Chi exercise) or to intervention group 2 (self management)

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 2, 2021
• Study Start: December 10, 2020
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

KR (1)