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

Jing Tao

Status: Completed

Conditions: Cognitive Dysfunction; Diabetes Mellitus, Type 2

Treatments: Behavioral: Tai Chi Chuan; Behavioral: Fitness Walking; Behavioral: Standard Diabetic Care Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04416841

FujianUTCM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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328 participants in 3 patient groups

Tai Chi Chuan Group

Experimental group

Description:

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.

Treatment:

Behavioral: Tai Chi Chuan

Fitness Walking Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Fitness Walking

Control group

Other group

Description:

In addition to conventional medical treatment, participants will receive standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.

Treatment:

Behavioral: Standard Diabetic Care Education