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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416841
• Other study ID #: FujianUTCM
• Status: Completed
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: August 20, 2022

Study information

• Verified date: September 2022
• Source: Fujian University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: August 20, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Tai 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.
• Fitness 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.
• Standard Diabetic Care Education
Participants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.

Locations

Country	Name	City	State
China	Fujian University of Traditional Chinese Medicine	Fuzhou	Fujian

Sponsors (6)

Lead Sponsor	Collaborator
Jing Tao	Bao'an District People's Hospital of Shenzhen, Peking University, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, University of Electronic Science and Technology of China, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (6)

Bai A, Tao L, Huang J, Tao J, Liu J. Effects of physical activity on cognitive function among patients with diabetes in China: a nationally longitudinal study. BMC Public Health. 2021 Mar 11;21(1):481. doi: 10.1186/s12889-021-10537-x. — View Citation

Guo S, Xu Y, Qin J, Chen Y, You Y, Tao J, Liu Z, Huang J. Effect of tai chi on glycaemic control, lipid metabolism and body composition in adults with type 2 diabetes: A meta-analysis and systematic review. J Rehabil Med. 2021 Mar 22;53(3):jrm00165. doi: 10.2340/16501977-2799. — View Citation

Qin J, Chen Y, Guo S, You Y, Xu Y, Wu J, Liu Z, Huang J, Chen L, Tao J. Effect of Tai Chi on Quality of Life, Body Mass Index, and Waist-Hip Ratio in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2021 Jan 19;11:543627. doi: 10.3389/fendo.2020.543627. eCollection 2020. — View Citation

Xie J, Yin L, Huang J, Xu Y, Chen Y, Qin J, Liu Z, Tao J. Correlation between impaired hemodynamic response and cardiopulmonary fitness in middle-aged type 2 diabetes mellitus patients: a case-control study. Eur J Appl Physiol. 2022 Oct;122(10):2295-2303. doi: 10.1007/s00421-022-05008-z. Epub 2022 Jul 20. — View Citation

Yin L, Qin J, Chen Y, Xie J, Hong C, Huang J, Xu Y, Liu Z, Tao J. Impact of Body Mass Index on Static Postural Control in Adults With and Without Diabetes: A Cross-Sectional Study. Front Endocrinol (Lausanne). 2021 Dec 24;12:768185. doi: 10.3389/fendo.2021.768185. eCollection 2021. — View Citation

You Y, Liu Z, Chen Y, Xu Y, Qin J, Guo S, Huang J, Tao J. The prevalence of mild cognitive impairment in type 2 diabetes mellitus patients: a systematic review and meta-analysis. Acta Diabetol. 2021 Jun;58(6):671-685. doi: 10.1007/s00592-020-01648-9. Epub 2021 Jan 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood glucose metabolism index at 24, 36 weeks	fasting blood glucose; glycosylated hemoglobin; fasting insulin	24, 36 weeks
Other	Blood lipid metabolism index at 24, 36 weeks	total cholesterol (TC); total triglyceride (TG); low density lipoprotein (LDL),;high density lipoprotein (HDL).	24, 36 weeks
Other	Circulating levels of AGE and sRAGE at 24, 36 weeks	Circulating levels of AGE and sRAGE	24, 36 weeks
Other	functional Magnetic Resonance Imaging (fMRI)	functional Magnetic Resonance Imaging	baseline, 24 weeks
Primary	Global cognition-Montreal Cognitive Assessment at 36 Weeks	Montreal Cognitive Assessment	36 weeks (post-intervention follow-up)
Secondary	Global cognition-Montreal Cognitive Assessment at 24 weeks	Montreal Cognitive Assessment	24 weeks (post-intervention)
Secondary	Memory function-Wechsler Memory Scale at 24, 36 Weeks	Wechsler Memory Scale	24, 36 weeks
Secondary	Digital Symbol test at 24, 36 weeks	Digital Symbol test	24, 36 weeks
Secondary	Trial Making Test part B at 24, 36 weeks	Trial Making Test part B	24, 36 weeks
Secondary	Stroop color word test at 24, 36 weeks	Stroop color word test	24, 36 weeks
Secondary	Boston naming test at 24, 36 weeks	Boston naming test	24, 36 weeks
Secondary	Rey-Osterrieth complex graphics test at 24, 36 weeks	Rey-Osterrieth complex graphics test	24, 36 weeks
Secondary	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
Secondary	Functional reach test at 24, 36 weeks	Functional reach test	24, 36 weeks
Secondary	One leg stance test at 24, 36 weeks	One leg stance test	24, 36 weeks
Secondary	Grip strength at 24, 36 weeks	Grip strength	24, 36 weeks
Secondary	Five times sit-to-stand test at 24, 36 weeks	Five times sit-to-stand test	24, 36 weeks
Secondary	Sensation function at 24, 36 weeks	Tactile sensation; Two-point discrimination sensation; Vibration sensation.	24, 36 weeks
Secondary	Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks	Modified Falls Efficacy Scale	24, 36 weeks
Secondary	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