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Completed

NCT Number: NCT04416841

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cognition Disorders Cognitive Dysfunction Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, 350122, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinician diagnosis of T2DM;
  • presence of mild cognitive impairment, not demented;
  • age ≥ 60 years old;
  • 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);
  • informed consent and voluntary participation.

Exclusion criteria

  • cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
  • 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;
  • participating in other experiments that influence this study.

Treatment and study plan

Tai Chi Chuan

Behavioral

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

Behavioral

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

Behavioral

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

Primary outcomes

  1. Global cognition-Montreal Cognitive Assessment at 36 Weeks

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

    Montreal Cognitive Assessment

Secondary outcomes

  1. Global cognition-Montreal Cognitive Assessment at 24 weeks

    Time frame: 24 weeks (post-intervention)

    Montreal Cognitive Assessment

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

    Time frame: 24, 36 weeks

    Wechsler Memory Scale

  3. Digital Symbol test at 24, 36 weeks

    Time frame: 24, 36 weeks

    Digital Symbol test

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

    Time frame: 24, 36 weeks

    Trial Making Test part B

  5. Stroop color word test at 24, 36 weeks

    Time frame: 24, 36 weeks

    Stroop color word test

  6. Boston naming test at 24, 36 weeks

    Time frame: 24, 36 weeks

    Boston naming test

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

    Time frame: 24, 36 weeks

    Rey-Osterrieth complex graphics test

  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 frame: 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.

  9. Functional reach test at 24, 36 weeks

    Time frame: 24, 36 weeks

    Functional reach test

  10. One leg stance test at 24, 36 weeks

    Time frame: 24, 36 weeks

    One leg stance test

  11. Grip strength at 24, 36 weeks

    Time frame: 24, 36 weeks

    Grip strength

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

    Time frame: 24, 36 weeks

    Five times sit-to-stand test

  13. Sensation function at 24, 36 weeks

    Time frame: 24, 36 weeks

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

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

    Time frame: 24, 36 weeks

    Modified Falls Efficacy Scale

  15. Quality of life-Medical Outcomes Study 36-item Short-Form Health Survey at 24, 36 weeks

    Time frame: 24, 36 weeks

    Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)

Other outcomes

  1. Blood glucose metabolism index at 24, 36 weeks

    Time frame: 24, 36 weeks

    fasting blood glucose; glycosylated hemoglobin; fasting insulin

  2. Blood lipid metabolism index at 24, 36 weeks

    Time frame: 24, 36 weeks

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

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

    Time frame: 24, 36 weeks

    Circulating levels of AGE and sRAGE

  4. functional Magnetic Resonance Imaging (fMRI)

    Time frame: baseline, 24 weeks

    functional Magnetic Resonance Imaging

Sponsors and collaborators

Lead sponsor

Jing Tao

Other

Collaborators

  • Peking University
  • Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
  • Shenzhen Baoan District People's Hospital
  • University of Electronic Science and Technology of China
  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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