Diabetes Mellitus, Type 2NCT04416841

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

A study testing Tai Chi Chuan, Fitness Walking and Standard Diabetic Care Education in people with Diabetes Mellitus, Type 2 and Cognitive Dysfunction, run by Jing Tao at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Cognitive Dysfunction
What is being tested?: Tai Chi Chuan, Fitness Walking and Standard Diabetic Care Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 328 participants
Where: 1 siteChina
Study dates: 3 Jun 2020to 20 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350122

Other trials in China

About this study

Official title: 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.

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.

Conditions: Diabetes Mellitus, Type 2, Cognitive Dysfunction
Being tested: Tai Chi Chuan, Fitness Walking, Standard Diabetic Care Education
Keywords: Tai Chi Chuan, Cognitive Function, Postural Balance
Medical subject headings: Diabetes Mellitus, Type 2, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tai Chi ChuanBehavioural
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 WalkingBehavioural
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 EducationBehavioural
Participants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.

Study groups in NCT04416841
Study group	Role	What they receive
Tai Chi Chuan Group	Experimental	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. Receives: Behavioral: Tai Chi Chuan
Fitness Walking Group	Active comparator	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 Receives: Behavioral: Fitness Walking
Control group	Other	In addition to conventional medical treatment, participants will receive standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months. Receives: Behavioral: Standard Diabetic Care Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Global cognition-Montreal Cognitive Assessment at 36 Weeks
Montreal Cognitive Assessment
Measured: 36 weeks (post-intervention follow-up)

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202020 Aug 2022

First posted4 Jun 2020
Study start3 Jun 2020
Primary completion15 Mar 2022
Study completion20 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04416841
Sponsor's protocol ID: FujianUTCM
Status last verified: Sep 2022
First submitted: 26 May 2020
Last updated: 22 Sep 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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
Chen Y, Qin J, Tao L, Liu Z, Huang J, Liu W, Xu Y, Tang Q, Liu Y, Chen Z, Chen S, Liang S, Chen C, Xie J, Liu J, Chen L, Tao J. Effects of Tai Chi Chuan on Cognitive Function in Adults 60 Years or Older With Type 2 Diabetes and Mild Cognitive Impairment in China: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e237004. doi: 10.1001/jamanetworkopen.2023.7004.
PubMed 37022680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Tai Chi Chuan on Cognitive Function in Type 2 Diabetes Mellitus Patients Accompanied With Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT04416841
Acronym / sponsor ID: FujianUTCM
Conditions: Diabetes Mellitus, Type 2, Cognitive Dysfunction
Keywords: Tai Chi Chuan, Cognitive Function, Postural Balance
Study type: Interventional
Recruitment status: Completed
Enrolment: 328 participants (actual)
Lead sponsor: Jing TaoUniversity, hospital or other
Collaborators: Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Shenzhen Baoan District People's Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Peking University, University of Electronic Science and Technology of China
Study start: 3 Jun 2020 (actual)
Primary completion: 15 Mar 2022 (actual)
Study completion: 20 Aug 2022 (actual)
First posted: 4 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Tai Chi Chuan Group	Experimental	Behavioral: Tai Chi ChuanIn 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.
Fitness Walking Group	Active comparator	Behavioral: Fitness WalkingIn 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
Control group	Other	Behavioral: Standard Diabetic Care EducationIn addition to conventional medical treatment, participants will receive standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tai Chi ChuanParticipants 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.	Behavioural	Tai Chi Chuan Group
Fitness WalkingParticipants 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.	Behavioural	Fitness Walking Group
Standard Diabetic Care EducationParticipants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.	Behavioural	Control group

Primary outcome

Global cognition-Montreal Cognitive Assessment at 36 Weeks
Time frame: 36 weeks (post-intervention follow-up)
Montreal Cognitive Assessment

15 secondary outcomes

Global cognition-Montreal Cognitive Assessment at 24 weeks
Time frame: 24 weeks (post-intervention)
Memory function-Wechsler Memory Scale at 24, 36 Weeks
Time frame: 24, 36 weeks
Digital Symbol test at 24, 36 weeks
Time frame: 24, 36 weeks
Trial Making Test part B at 24, 36 weeks
Time frame: 24, 36 weeks
Stroop color word test at 24, 36 weeks
Time frame: 24, 36 weeks
Boston naming test at 24, 36 weeks
Time frame: 24, 36 weeks
Rey-Osterrieth complex graphics test at 24, 36 weeks
Time frame: 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
Functional reach test at 24, 36 weeks
Time frame: 24, 36 weeks
One leg stance test at 24, 36 weeks
Time frame: 24, 36 weeks
Grip strength at 24, 36 weeks
Time frame: 24, 36 weeks
Five times sit-to-stand test at 24, 36 weeks
Time frame: 24, 36 weeks
Sensation function at 24, 36 weeks
Time frame: 24, 36 weeks
Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks
Time frame: 24, 36 weeks
Quality of life-Medical Outcomes Study 36-item Short-Form Health Survey at 24, 36 weeks
Time frame: 24, 36 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
Background: PubMed 33417039You 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.
Background: PubMed 33542702Qin 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.
Background: PubMed 33594445Guo 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.
Background: PubMed 33706749Bai 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.
Background: PubMed 35002958Yin 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.
Background: PubMed 35859047Xie 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.
Derived from this study: PubMed 37022680Chen Y, Qin J, Tao L, Liu Z, Huang J, Liu W, Xu Y, Tang Q, Liu Y, Chen Z, Chen S, Liang S, Chen C, Xie J, Liu J, Chen L, Tao J. Effects of Tai Chi Chuan on Cognitive Function in Adults 60 Years or Older With Type 2 Diabetes and Mild Cognitive Impairment in China: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e237004. doi: 10.1001/jamanetworkopen.2023.7004.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi Chuan, Fitness Walking and Standard Diabetic Care Education in people with Diabetes Mellitus, Type 2 and Cognitive Dysfunction, run by Jing Tao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global cognition-Montreal Cognitive Assessment at 36 Weeks (time frame: 36 weeks (post-intervention follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04416841, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.