Tai Chi Quan Improving Biochemistry and Quality of Life in Type 2 Diabetes

June 18, 2018 updated by: Taipei City Hospital

Tai Chi Quan Improving Blood Glucose, Blood Lipid, and Quality of Life in Patients With Type 2 Diabetes

In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry profile, and also better quality of life and activity of autonomic nerve system (ANS). The subjects were randomize assigned to either Tai Chi group or control group. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose(FBG), triglycerides (TG), high and low density lipoprotein (HDL, LDL), creatinine(Cr), eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry index, and also better quality of life and activity of automatic nerve system. In the study, type 2 diabetes mellitus(T2DM) patients will be recruited as subjects. The subjects were randomized to either Tai Chi group or control group. Tai Chi group would take Tai Chi Quan training for 1hr, twice a week for 12 weeks. There were 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training. In this study, the 1st section of Yang style 108 form is chosen for the experiment group. Both group were given diabetic patients care education and the exercise recording book for encouraging the daily exercise habits. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose, triglycerides, high and low density lipid, creatinine, eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Taiwan
      • Taipei, Taiwan, 104
        • Recruiting
        • Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
        • Contact:
          • Chien-Jung Huang, Bachelor

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40~80 years old
  • Diagnosed type 2 diabetes mellitus, and without changing dietary pattern and medical treatment for blood glucose or blood lipid.
  • Consciousness clear and is voluntary to attend the project and with the agreement.
  • The functional movement ability is independent

Exclusion Criteria:

  • Pregnant or plan to be pregnant in six months, and breast feeding.
  • Severe complication in six months such as myocardial infarction, stroke, severe traumatic injury, major surgery. Other diseases evaluated by the doctor that are not suitable for the project.
  • Evaluated that the compliance for the intervention is not appropriate.
  • The blood glucose > 300mg/dl and unable to do vigorous exercise.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tai Chi Quan for Type 2 Diabetes
diabetic patients care education and Tai Chi Quan training, including 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training, twice a week for 12 weeks.
Behavioral: Tai Chi Quan
the first section of Yang style 108 form, including 10-minute warm-up, 40-minute training, and 10-minute cool-down exercise, twice a week
No Intervention: Control Group for Type 2 Diabetes
diabetic patients care education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: change from Baseline to 12 weeks
HbA1c
change from Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting blood glucose
Time Frame: change from Baseline to 12 weeks
blood sample after 8-hour fasting
change from Baseline to 12 weeks
triglycerides
Time Frame: change from Baseline to 12 weeks
blood sample after 8-hour fasting
change from Baseline to 12 weeks
high and low density lipoprotein
Time Frame: change from Baseline to 12 weeks
blood sample after 8-hour fasting
change from Baseline to 12 weeks
creatinine
Time Frame: change from Baseline to 12 weeks
blood sample after 8-hour fasting
change from Baseline to 12 weeks
estimated Glomerular Filtration Rate (eGFR)
Time Frame: change from Baseline to 12 weeks
blood sample after 8-hour fasting
change from Baseline to 12 weeks
Glutamic-Pyruvic Transaminase (GPT)
Time Frame: change from Baseline to 12 weeks
blood sample after 8-hour fasting
change from Baseline to 12 weeks
urine albumin/creatinine ratio (ACR)
Time Frame: change from Baseline to 12 weeks
from urine sample
change from Baseline to 12 weeks
quality of life
Time Frame: change from Baseline to 12 weeks
WHOQOL-BREF Taiwan
change from Baseline to 12 weeks
heart rate variability
Time Frame: change from Baseline to 12 weeks
represent for balance of autonomic nervous system
change from Baseline to 12 weeks
low frequency (LF)
Time Frame: change from Baseline to 12 weeks
Low frequency is the frequency domain analysis from heart rate variability, and is represent for sympathetic nervous system
change from Baseline to 12 weeks
high frequency (HF)
Time Frame: change from Baseline to 12 weeks
High frequency is the frequency domain analysis from heart rate variability, and is represent for parasympathetic nervous system
change from Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Collaborators

National Yang Ming University

Investigators

  • Study Chair: Chien-Jung Huang, Bachelor, Taipei City Hospital

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)

May 22, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TaipeiCityH

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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