Clinical trial NCT03562078: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Tai Chi Quan
HbA1c
quality of life
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2018-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Hemoglobin
timeFrame: change from Baseline to 12 weeks
Secondary outcomes:
measure: fasting blood glucose
timeFrame: change from Baseline to 12 weeks
measure: triglycerides
timeFrame: change from Baseline to 12 weeks
measure: high and low density lipoprotein
timeFrame: change from Baseline to 12 weeks
measure: creatinine
timeFrame: change from Baseline to 12 weeks
measure: estimated Glomerular Filtration Rate (eGFR)
timeFrame: change from Baseline to 12 weeks
measure: Glutamic-Pyruvic Transaminase (GPT)
timeFrame: change from Baseline to 12 weeks
measure: urine albumin/creatinine ratio (ACR)
timeFrame: change from Baseline to 12 weeks
measure: quality of life
timeFrame: change from Baseline to 12 weeks
measure: heart rate variability
timeFrame: change from Baseline to 12 weeks
measure: low frequency (LF)
timeFrame: change from Baseline to 12 weeks
measure: high frequency (HF)
timeFrame: change from Baseline to 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
Study officials:
affiliation: Taipei City Hospital
name: Chien-Jung Huang, Bachelor
role: STUDY_CHAIR
References: