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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Cognitive Dysfunction
• Interventions: Behavioral: Tai Chi Chuan; Behavioral: Fitness Walking; Behavioral: Standard Diabetic Care Education

• Registration Number: NCT04416841
• Lead Sponsor: Jing Tao

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.

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-01
• Study Start: 2020-06-03
• Study First Posted: 2020-06-04
• Primary Completion: 2022-03-15
• Study Completion: 2022-08-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai Chi Chuan Group	Tai Chi Chuan	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.
Fitness Walking Group	Fitness Walking	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
Control group	Standard Diabetic Care Education	In addition to conventional medical treatment, participants will receive standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.

Primary Outcome Measures

Name	Time	Method
Global cognition-Montreal Cognitive Assessment at 36 Weeks	36 weeks (post-intervention follow-up)	Montreal Cognitive Assessment

Secondary Outcome Measures

Name	Time	Method
Trial Making Test part B at 24, 36 weeks	24, 36 weeks	Trial Making Test part B
Grip strength at 24, 36 weeks	24, 36 weeks	Grip strength
Digital Symbol test at 24, 36 weeks	24, 36 weeks	Digital Symbol test
Global cognition-Montreal Cognitive Assessment at 24 weeks	24 weeks (post-intervention)	Montreal Cognitive Assessment
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.
Memory function-Wechsler Memory Scale at 24, 36 Weeks	24, 36 weeks	Wechsler Memory Scale
Functional reach test at 24, 36 weeks	24, 36 weeks	Functional reach 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
Rey-Osterrieth complex graphics test at 24, 36 weeks	24, 36 weeks	Rey-Osterrieth complex graphics test
One leg stance test at 24, 36 weeks	24, 36 weeks	One leg stance test
Five times sit-to-stand test at 24, 36 weeks	24, 36 weeks	Five times sit-to-stand test
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)

Trial Locations

Locations (1)

Fujian University of Traditional Chinese Medicine; 🇨🇳 Fuzhou, Fujian, China