Tai Chi Chuan as Rehabilitation Program for Mild Cognitive Impairment in Type 2 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Tai Chi Chuan on Cognitive Function in Type 2 Diabetes Mellitus Patients Accompanied With Mild Cognitive Impairment

Conditions
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Diabetes Mellitus, Type 2, Cognitive Dysfunction

Intervention / Treatment
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* Behavioral: Tai Chi Chuan
* Behavioral: Fitness Walking
* Behavioral: Standard Diabetic Care Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinician diagnosis of T2DM; presence of mild cognitive impairment, not demented; age ≥ 60 years old; 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); informed consent and voluntary participation. Exclusion Criteria: cognitive impairment caused by other reasons, taking drugs, poisoning, etc; 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; participating in other experiments that influence this study.

Ages Eligible for Study
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Minimum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi Chuan Group<br>In addition to conventional medical treatment, participants will receive 3 sessions of 1-hour Tai Chi Chuan training per week for 24 weeks and standard diabetic care education. | Behavioral: Tai Chi Chuan<br>* 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.<br>|
| Active Comparator: Fitness Walking Group<br>In addition to conventional medical treatment, participants will receive 3 sessions of 1-hour fitness walking training per week for 24 weeks and standard diabetic care education | Behavioral: Fitness Walking<br>* 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.<br>|
| Other: Control group<br>In addition to conventional medical treatment, participants will receive standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months. | Behavioral: Standard Diabetic Care Education<br>* Participants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cognition-Montreal Cognitive Assessment at 36 Weeks | Montreal Cognitive Assessment | 36 weeks (post-intervention follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cognition-Montreal Cognitive Assessment at 24 weeks | Montreal Cognitive Assessment | 24 weeks (post-intervention) | 
| Memory function-Wechsler Memory Scale at 24, 36 Weeks | Wechsler Memory Scale | 24, 36 weeks | 
| Digital Symbol test at 24, 36 weeks | Digital Symbol test | 24, 36 weeks | 
| Trial Making Test part B at 24, 36 weeks | Trial Making Test part B | 24, 36 weeks | 
| Stroop color word test at 24, 36 weeks | Stroop color word test | 24, 36 weeks | 
| Boston naming test at 24, 36 weeks | Boston naming test | 24, 36 weeks | 
| Rey-Osterrieth complex graphics test at 24, 36 weeks | Rey-Osterrieth complex graphics test | 24, 36 weeks | 
| 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 | 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. | 24, 36 weeks | 
| Functional reach test at 24, 36 weeks | Functional reach test | 24, 36 weeks | 
| One leg stance test at 24, 36 weeks | One leg stance test | 24, 36 weeks | 
| Grip strength at 24, 36 weeks | Grip strength | 24, 36 weeks | 
| Five times sit-to-stand test at 24, 36 weeks | Five times sit-to-stand test | 24, 36 weeks | 
| Sensation function at 24, 36 weeks | Tactile sensation; Two-point discrimination sensation; Vibration sensation. | 24, 36 weeks | 
| Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks | Modified Falls Efficacy Scale | 24, 36 weeks | 
| Quality of life-Medical Outcomes Study 36-item Short-Form Health Survey at 24, 36 weeks | Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | 24, 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tai Chi Chuan, Cognitive Function, Postural Balance