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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Tai Chi Quan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi Quan for Type 2 Diabetes<br>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<br>* 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<br>|
| No Intervention: Control Group for Type 2 Diabetes<br>diabetic patients care education | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tai Chi Quan, HbA1c, quality of life