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

September 20, 2022 updated by: Jing Tao

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350122
        • Fujian University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.
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
Participants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global cognition-Montreal Cognitive Assessment at 36 Weeks
Time Frame: 36 weeks (post-intervention follow-up)
Montreal Cognitive Assessment
36 weeks (post-intervention follow-up)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose metabolism index at 24, 36 weeks
Time Frame: 24, 36 weeks
fasting blood glucose; glycosylated hemoglobin; fasting insulin
24, 36 weeks
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).
24, 36 weeks
Circulating levels of AGE and sRAGE at 24, 36 weeks
Time Frame: 24, 36 weeks
Circulating levels of AGE and sRAGE
24, 36 weeks
functional Magnetic Resonance Imaging (fMRI)
Time Frame: baseline, 24 weeks
functional Magnetic Resonance Imaging
baseline, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing Tao

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2020

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

August 20, 2022

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FujianUTCM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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