Cognitive Dysfunction, Diabetes Mellitus, Type 2
Conditions
Keywords
Tai Chi Chuan, Cognitive Function, Postural Balance
Brief summary
The patients with type 2 diabetes mellitus (T2DM) is expected to rise to 439 million in 2030, accounting for 7.7% the population in the world. There are nearly 10 million T2DM patients with mild cognitive impairment (MCI) among people over 65 years old , accounting for about 8% of the people over 65 years old in China. The medical cost for patients with T2DM/MCI is 2.5 to 4 times higher than those without T2DM. And T2DM will increase the risk of cognitive impairment, and lead to various complications which will bring serious social and medical economic burden.
Detailed description
It is critically important to identify effective treatments to enhance functional status of T2DM/MCI patients. Exercise has been shown to be beneficial for T2DM/MCI patients. As a Chinese traditional mind-body exercise that consists of both physical and mediation components, Tai Chi Chuan has been proved to be helpful in global cognition, memory, executive function and attention of MCI, and blood sugar of T2DM. However, the evidence of the effect of Tai Chi Chuan on T2DM/MCI patients is limited. The purpose of this study is to explore the effect of Tai Chi Chuan treating T2DM/MCI patients in cognitive function, balance, motor and sensation function, blood sugar, biochemistry profile and quality of life.
Interventions
BEHAVIORALTai Chi Chuan
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
BEHAVIORALFitness Walking
Participants would take fitness walking training 1 hour/session, 3sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes fitness walking and 10 minutes cool-down exercises in the fitness walking training, the exercise intensity was 50% to 70% of the maximum heart rate. Besides, they would also take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
BEHAVIORALStandard Diabetic Care Education
Participants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
Sponsors
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Bao'an District People's Hospital of Shenzhen
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Peking University
University of Electronic Science and Technology of China
Jing Tao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. clinician diagnosis of T2DM; 2. presence of mild cognitive impairment, not demented; 3. age ≥ 60 years old; 4. did not engage in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time); 5. informed consent and voluntary participation.
Exclusion criteria
1. cognitive impairment caused by other reasons, taking drugs, poisoning, etc; 2. presence of medical conditions that unable or unsafe to exercise, such as depression symptoms, uncontrolled hypertension/ blood pressure/ blood glucose, nervous system diseases(stroke, Parkinson's disease, etc), musculoskeletal system diseases(arthritis, history of hip and/or knee joint replacement, etc), etc; 3. participating in other experiments that influence this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global cognition-Montreal Cognitive Assessment at 36 Weeks | 36 weeks (post-intervention follow-up) | Montreal Cognitive Assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rey-Osterrieth complex graphics test at 24, 36 weeks | 24, 36 weeks | Rey-Osterrieth complex graphics test |
| Five times sit-to-stand test at 24, 36 weeks | 24, 36 weeks | Five times sit-to-stand test |
| Sensation function at 24, 36 weeks | 24, 36 weeks | Tactile sensation; Two-point discrimination sensation; Vibration sensation. |
| Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks | 24, 36 weeks | Modified Falls Efficacy Scale |
| Quality of life-Medical Outcomes Study 36-item Short-Form Health Survey at 24, 36 weeks | 24, 36 weeks | Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) |
| Global cognition-Montreal Cognitive Assessment at 24 weeks | 24 weeks (post-intervention) | Montreal Cognitive Assessment |
| Memory function-Wechsler Memory Scale at 24, 36 Weeks | 24, 36 weeks | Wechsler Memory Scale |
| Digital Symbol test at 24, 36 weeks | 24, 36 weeks | Digital Symbol test |
| Trial Making Test part B at 24, 36 weeks | 24, 36 weeks | Trial Making Test part B |
| Stroop color word test at 24, 36 weeks | 24, 36 weeks | Stroop color word test |
| Boston naming test at 24, 36 weeks | 24, 36 weeks | Boston naming test |
| Multi-task balance test: Time up and go test; Time up and go test + cognitive task;Time up and go test + motor task;Time up and go test + cognitive task + motor task at 24, 36 weeks | 24, 36 weeks | Time up and go test; Time up and go test + cognitive task (animal naming); Time up and go test + motor task (holding a cup of water); Time up and go test + cognitive task + motor task. |
| Functional reach test at 24, 36 weeks | 24, 36 weeks | Functional reach test |
| One leg stance test at 24, 36 weeks | 24, 36 weeks | One leg stance test |
| Grip strength at 24, 36 weeks | 24, 36 weeks | Grip strength |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose metabolism index at 24, 36 weeks | 24, 36 weeks | fasting blood glucose; glycosylated hemoglobin; fasting insulin |
| functional Magnetic Resonance Imaging (fMRI) | baseline, 24 weeks | functional Magnetic Resonance Imaging |
| Blood lipid metabolism index at 24, 36 weeks | 24, 36 weeks | total cholesterol (TC); total triglyceride (TG); low density lipoprotein (LDL),;high density lipoprotein (HDL). |
| Circulating levels of AGE and sRAGE at 24, 36 weeks | 24, 36 weeks | Circulating levels of AGE and sRAGE |
Countries
China
Outcome results
None listed