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

Primary Purpose

Diabetes Mellitus, Type 2, Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tai Chi Chuan
Fitness Walking
Standard Diabetic Care Education
Sponsored by
Jing Tao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Tai Chi Chuan, Cognitive Function, Postural Balance

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fujian University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Tai Chi Chuan Group

Fitness Walking Group

Control group

Arm Description

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.

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

In addition to conventional medical treatment, participants will receive standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.

Outcomes

Primary Outcome Measures

Global cognition-Montreal Cognitive Assessment at 36 Weeks
Montreal Cognitive Assessment

Secondary Outcome Measures

Global cognition-Montreal Cognitive Assessment at 24 weeks
Montreal Cognitive Assessment
Memory function-Wechsler Memory Scale at 24, 36 Weeks
Wechsler Memory Scale
Digital Symbol test at 24, 36 weeks
Digital Symbol test
Trial Making Test part B at 24, 36 weeks
Trial Making Test part B
Stroop color word test at 24, 36 weeks
Stroop color word test
Boston naming test at 24, 36 weeks
Boston naming test
Rey-Osterrieth complex graphics test at 24, 36 weeks
Rey-Osterrieth complex graphics 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
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.
Functional reach test at 24, 36 weeks
Functional reach test
One leg stance test at 24, 36 weeks
One leg stance test
Grip strength at 24, 36 weeks
Grip strength
Five times sit-to-stand test at 24, 36 weeks
Five times sit-to-stand test
Sensation function at 24, 36 weeks
Tactile sensation; Two-point discrimination sensation; Vibration sensation.
Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks
Modified Falls Efficacy Scale
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)

Full Information

First Posted
May 26, 2020
Last Updated
September 20, 2022
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
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1. Study Identification

Unique Protocol Identification Number
NCT04416841
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cognitive Dysfunction
Keywords
Tai Chi Chuan, Cognitive Function, Postural Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi Chuan Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Fitness Walking Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
Other
Arm Description
In addition to conventional medical treatment, participants will receive standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi Chuan
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fitness Walking
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Diabetic Care Education
Intervention Description
Participants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
Primary Outcome Measure Information:
Title
Global cognition-Montreal Cognitive Assessment at 36 Weeks
Description
Montreal Cognitive Assessment
Time Frame
36 weeks (post-intervention follow-up)
Secondary Outcome Measure Information:
Title
Global cognition-Montreal Cognitive Assessment at 24 weeks
Description
Montreal Cognitive Assessment
Time Frame
24 weeks (post-intervention)
Title
Memory function-Wechsler Memory Scale at 24, 36 Weeks
Description
Wechsler Memory Scale
Time Frame
24, 36 weeks
Title
Digital Symbol test at 24, 36 weeks
Description
Digital Symbol test
Time Frame
24, 36 weeks
Title
Trial Making Test part B at 24, 36 weeks
Description
Trial Making Test part B
Time Frame
24, 36 weeks
Title
Stroop color word test at 24, 36 weeks
Description
Stroop color word test
Time Frame
24, 36 weeks
Title
Boston naming test at 24, 36 weeks
Description
Boston naming test
Time Frame
24, 36 weeks
Title
Rey-Osterrieth complex graphics test at 24, 36 weeks
Description
Rey-Osterrieth complex graphics test
Time Frame
24, 36 weeks
Title
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
Description
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
Title
Functional reach test at 24, 36 weeks
Description
Functional reach test
Time Frame
24, 36 weeks
Title
One leg stance test at 24, 36 weeks
Description
One leg stance test
Time Frame
24, 36 weeks
Title
Grip strength at 24, 36 weeks
Description
Grip strength
Time Frame
24, 36 weeks
Title
Five times sit-to-stand test at 24, 36 weeks
Description
Five times sit-to-stand test
Time Frame
24, 36 weeks
Title
Sensation function at 24, 36 weeks
Description
Tactile sensation; Two-point discrimination sensation; Vibration sensation.
Time Frame
24, 36 weeks
Title
Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks
Description
Modified Falls Efficacy Scale
Time Frame
24, 36 weeks
Title
Quality of life-Medical Outcomes Study 36-item Short-Form Health Survey at 24, 36 weeks
Description
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
Time Frame
24, 36 weeks
Other Pre-specified Outcome Measures:
Title
Blood glucose metabolism index at 24, 36 weeks
Description
fasting blood glucose; glycosylated hemoglobin; fasting insulin
Time Frame
24, 36 weeks
Title
Blood lipid metabolism index at 24, 36 weeks
Description
total cholesterol (TC); total triglyceride (TG); low density lipoprotein (LDL),;high density lipoprotein (HDL).
Time Frame
24, 36 weeks
Title
Circulating levels of AGE and sRAGE at 24, 36 weeks
Description
Circulating levels of AGE and sRAGE
Time Frame
24, 36 weeks
Title
functional Magnetic Resonance Imaging (fMRI)
Description
functional Magnetic Resonance Imaging
Time Frame
baseline, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fujian University of Traditional Chinese Medicine
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350122
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33417039
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.
Results Reference
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PubMed Identifier
33542702
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.
Results Reference
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PubMed Identifier
33594445
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.
Results Reference
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PubMed Identifier
33706749
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.
Results Reference
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PubMed Identifier
35002958
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.
Results Reference
background
PubMed Identifier
35859047
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.
Results Reference
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Tai Chi Chuan as Rehabilitation Program for Mild Cognitive Impairment in Type 2 Diabetes Mellitus Patients

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