NCT04416841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

June 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

1.8 years

First QC Date

May 26, 2020

Last Update Submit

September 20, 2022

Conditions

Diabetes Mellitus, Type 2Cognitive Dysfunction

Keywords

Tai Chi ChuanCognitive FunctionPostural Balance

Outcome Measures

Primary Outcomes (1)

  • Global cognition-Montreal Cognitive Assessment at 36 Weeks

    Montreal Cognitive Assessment

    36 weeks (post-intervention follow-up)

Secondary Outcomes (15)

  • Global cognition-Montreal Cognitive Assessment at 24 weeks

    24 weeks (post-intervention)

  • Memory function-Wechsler Memory Scale at 24, 36 Weeks

    24, 36 weeks

  • Digital Symbol test at 24, 36 weeks

    24, 36 weeks

  • Trial Making Test part B at 24, 36 weeks

    24, 36 weeks

  • Stroop color word test at 24, 36 weeks

    24, 36 weeks

  • +10 more secondary outcomes

Other Outcomes (4)

  • Blood glucose metabolism index at 24, 36 weeks

    24, 36 weeks

  • Blood lipid metabolism index at 24, 36 weeks

    24, 36 weeks

  • Circulating levels of AGE and sRAGE at 24, 36 weeks

    24, 36 weeks

  • +1 more other outcomes

Study Arms (3)

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.

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

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.

Behavioral: Standard Diabetic Care Education

Interventions

Tai Chi ChuanBEHAVIORAL

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.

Tai Chi Chuan Group
Fitness WalkingBEHAVIORAL

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.

Fitness Walking Group
Standard Diabetic Care EducationBEHAVIORAL

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

Control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian University of Traditional Chinese Medicine

Fuzhou, Fujian, 350122, China

Location

Related Publications (7)

  • 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.

    PMID: 33417039BACKGROUND

  • 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.

    PMID: 33542702BACKGROUND

  • 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.

    PMID: 33594445BACKGROUND

  • 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.

    PMID: 33706749BACKGROUND

  • 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.

    PMID: 35002958BACKGROUND

  • 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.

    PMID: 35859047BACKGROUND

  • 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.

    PMID: 37022680DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cognitive Dysfunction

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 4, 2020

Study Start

June 3, 2020

Primary Completion

March 15, 2022

Study Completion

August 20, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

CN(1)