Clinical trial NCT04416841: Tai Chi Chuan as Rehabilitation Program for Mild Cognitive Impairment in Type 2 Diabetes Mellitus Patients
Official title: Efficacy of Tai Chi Chuan on Cognitive Function in Type 2 Diabetes Mellitus Patients Accompanied With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Cognitive Dysfunction
Keywords: Tai Chi Chuan
Cognitive Function
Postural Balance
Lead sponsor: Fujian University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
name: Bao'an District People's Hospital of Shenzhen
name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Peking University
name: University of Electronic Science and Technology of China
First posted: 2020-06-04
Enrollment: 328
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global cognition-Montreal Cognitive Assessment at 36 Weeks
timeFrame: 36 weeks (post-intervention follow-up)
Secondary outcomes:
measure: Global cognition-Montreal Cognitive Assessment at 24 weeks
timeFrame: 24 weeks (post-intervention)
measure: Memory function-Wechsler Memory Scale at 24, 36 Weeks
timeFrame: 24, 36 weeks
measure: Digital Symbol test at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Trial Making Test part B at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Stroop color word test at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Boston naming test at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Rey-Osterrieth complex graphics test at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: 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
timeFrame: 24, 36 weeks
measure: Functional reach test at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: One leg stance test at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Grip strength at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Five times sit-to-stand test at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Sensation function at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Quality of life-Medical Outcomes Study 36-item Short-Form Health Survey at 24, 36 weeks
timeFrame: 24, 36 weeks
Other outcomes:
measure: Blood glucose metabolism index at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Blood lipid metabolism index at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: Circulating levels of AGE and sRAGE at 24, 36 weeks
timeFrame: 24, 36 weeks
measure: functional Magnetic Resonance Imaging (fMRI)
timeFrame: baseline, 24 weeks
Locations:
city: Fuzhou
country: China
facility: Fujian University of Traditional Chinese Medicine
state: Fujian
Study officials:
References:
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.
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.
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.
citation: 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.
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.
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.