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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tai Chi Quan
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Tai Chi Quan, HbA1c, quality of life

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Linsen Chinese Medicine and Kunming Branch, Taipei City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tai Chi Quan for Type 2 Diabetes

Control Group for Type 2 Diabetes

Arm Description

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.

diabetic patients care education

Outcomes

Primary Outcome Measures

Hemoglobin
HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2018
Last Updated
June 18, 2018
Sponsor
Taipei City Hospital
Collaborators
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT03562078
Brief Title
Tai Chi Quan Improving Biochemistry and Quality of Life in Type 2 Diabetes
Official Title
Tai Chi Quan Improving Blood Glucose, Blood Lipid, and Quality of Life in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei City Hospital
Collaborators
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Tai Chi Quan, HbA1c, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi Quan for Type 2 Diabetes
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group for Type 2 Diabetes
Arm Type
No Intervention
Arm Description
diabetic patients care education
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi Quan
Intervention Description
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
Primary Outcome Measure Information:
Title
Hemoglobin
Description
HbA1c
Time Frame
change from Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
fasting blood glucose
Description
blood sample after 8-hour fasting
Time Frame
change from Baseline to 12 weeks
Title
triglycerides
Description
blood sample after 8-hour fasting
Time Frame
change from Baseline to 12 weeks
Title
high and low density lipoprotein
Description
blood sample after 8-hour fasting
Time Frame
change from Baseline to 12 weeks
Title
creatinine
Description
blood sample after 8-hour fasting
Time Frame
change from Baseline to 12 weeks
Title
estimated Glomerular Filtration Rate (eGFR)
Description
blood sample after 8-hour fasting
Time Frame
change from Baseline to 12 weeks
Title
Glutamic-Pyruvic Transaminase (GPT)
Description
blood sample after 8-hour fasting
Time Frame
change from Baseline to 12 weeks
Title
urine albumin/creatinine ratio (ACR)
Description
from urine sample
Time Frame
change from Baseline to 12 weeks
Title
quality of life
Description
WHOQOL-BREF Taiwan
Time Frame
change from Baseline to 12 weeks
Title
heart rate variability
Description
represent for balance of autonomic nervous system
Time Frame
change from Baseline to 12 weeks
Title
low frequency (LF)
Description
Low frequency is the frequency domain analysis from heart rate variability, and is represent for sympathetic nervous system
Time Frame
change from Baseline to 12 weeks
Title
high frequency (HF)
Description
High frequency is the frequency domain analysis from heart rate variability, and is represent for parasympathetic nervous system
Time Frame
change from Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Jung Huang, Bachelor
Phone
(+886)2-2591-6681
Ext
1262
Email
DAI62@tpech.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Jung Huang, Bachelor
Organizational Affiliation
Taipei City Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Jung Huang, Bachelor

12. IPD Sharing Statement

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

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