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

NCT ID: NCT04416841

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2022-08-20

Brief Summary

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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

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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

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Diabetes Mellitus, Type 2 Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tai Chi Chuan

Intervention Type 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 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

Group Type ACTIVE_COMPARATOR

Fitness Walking

Intervention Type 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.

Control group

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

Group Type OTHER

Standard Diabetic Care Education

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Standard Diabetic Care Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

OTHER

Sponsor Role collaborator

Bao'an District People's Hospital of Shenzhen

UNKNOWN

Sponsor Role collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role collaborator

University of Electronic Science and Technology of China

OTHER

Sponsor Role collaborator

Jing Tao

OTHER

Sponsor Role lead

Responsible Party

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Jing Tao

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 33417039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33542702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33594445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33706749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35002958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35859047 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37022680 (View on PubMed)

Other Identifiers

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FujianUTCM

Identifier Type: -

Identifier Source: org_study_id

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