CClinicalTrials.gg
CompletedNCT04416841Updated Sep 22, 2022

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

An interventional study of Tai Chi Chuan and Fitness Walking in Diabetes Mellitus, Type 2 and Cognitive Dysfunction, sponsored by Jing Tao. Completed at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-09-22.

Sponsored by Jing Tao · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
328
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Cognitive Dysfunction

Keywords

  • Tai Chi Chuan
  • Cognitive Function
  • Postural Balance
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 328 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Jing Tao is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
328 participants (actual)

Study arms

  • Experimental
    Tai Chi Chuan Group

    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

  • Active comparator
    Fitness Walking Group

    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

  • Other
    Control group

    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

Interventions

  • BehavioralTai 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.

  • BehavioralFitness 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.

  • BehavioralStandard Diabetic Care Education

    Participants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.

06

What researchers measure

Primary outcomes

  1. Global cognition-Montreal Cognitive Assessment at 36 Weeks

    Montreal Cognitive Assessment

    Time frame: 36 weeks (post-intervention follow-up)

Secondary outcomes

  1. Global cognition-Montreal Cognitive Assessment at 24 weeks

    Montreal Cognitive Assessment

    Time frame: 24 weeks (post-intervention)

  2. Memory function-Wechsler Memory Scale at 24, 36 Weeks

    Wechsler Memory Scale

    Time frame: 24, 36 weeks

  3. Digital Symbol test at 24, 36 weeks

    Digital Symbol test

    Time frame: 24, 36 weeks

  4. Trial Making Test part B at 24, 36 weeks

    Trial Making Test part B

    Time frame: 24, 36 weeks

  5. Stroop color word test at 24, 36 weeks

    Stroop color word test

    Time frame: 24, 36 weeks

  6. Boston naming test at 24, 36 weeks

    Boston naming test

    Time frame: 24, 36 weeks

  7. Rey-Osterrieth complex graphics test at 24, 36 weeks

    Rey-Osterrieth complex graphics test

    Time frame: 24, 36 weeks

  8. 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.

    Time frame: 24, 36 weeks

  9. Functional reach test at 24, 36 weeks

    Functional reach test

    Time frame: 24, 36 weeks

  10. One leg stance test at 24, 36 weeks

    One leg stance test

    Time frame: 24, 36 weeks

  11. Grip strength at 24, 36 weeks

    Grip strength

    Time frame: 24, 36 weeks

  12. Five times sit-to-stand test at 24, 36 weeks

    Five times sit-to-stand test

    Time frame: 24, 36 weeks

  13. Sensation function at 24, 36 weeks

    Tactile sensation; Two-point discrimination sensation; Vibration sensation.

    Time frame: 24, 36 weeks

  14. Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks

    Modified Falls Efficacy Scale

    Time frame: 24, 36 weeks

  15. 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)

    Time frame: 24, 36 weeks

Other outcomes

  1. Blood glucose metabolism index at 24, 36 weeks

    fasting blood glucose; glycosylated hemoglobin; fasting insulin

    Time frame: 24, 36 weeks

  2. Blood lipid metabolism index at 24, 36 weeks

    total cholesterol (TC); total triglyceride (TG); low density lipoprotein (LDL),;high density lipoprotein (HDL).

    Time frame: 24, 36 weeks

  3. Circulating levels of AGE and sRAGE at 24, 36 weeks

    Circulating levels of AGE and sRAGE

    Time frame: 24, 36 weeks

  4. functional Magnetic Resonance Imaging (fMRI)

    functional Magnetic Resonance Imaging

    Time frame: baseline, 24 weeks

07

Study locations

1 site
  • Fujian University of Traditional Chinese Medicine
    Fuzhou, Fujian 350122, China
08

References and documents

Publications

  • 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. PubMed 33417039 ↗
  • 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. PubMed 33542702 ↗
  • 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. PubMed 33594445 ↗
  • 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. PubMed 33706749 ↗
  • 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. PubMed 35002958 ↗
  • 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. PubMed 35859047 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04416841
Lead sponsor
Jing Tao
Collaborators
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Bao'an District People's Hospital of Shenzhen, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Peking University, University of Electronic Science and Technology of China
Responsible party
Jing Tao (PhD, Fujian University of Traditional Chinese Medicine) — Sponsor-investigator
First posted
Jun 4, 2020
Start date
Jun 3, 2020
Primary completion
Mar 15, 2022
Completion
Aug 20, 2022
Last update
Sep 22, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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