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Status unknownNCT05310890TIMEUpdated Aug 1, 2022

Long Term Prospective Study of Tai Chi Intervention to Prevent MCI From Conversion to Dementia

An interventional study of Tai chi training and Group activity in Mild Cognitive Impairment, sponsored by Ruijin Hospital. Status unknown. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-01.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study summary

This study evaluates the effects of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia. Patients will be randomized into the Tai chi training group and the control group.

Read the detailed description

Dementia is a syndrome of impairments of cortical functions caused by brain diseases. More than 55 million people worldwide are currently living with dementia, with nearly 10 million new cases each year. Alzheimer's disease is the most common form of dementia and may account for 60-70% of patients with dementia. Mild cognitive impairment (MCI) is an intermediate state between normal cognitive aging and dementia. About 10% to 15% of patients with MCI progress to dementia each year. Therefore, it is crucial to find intervention strategies to prevent the progression of MCI to dementia. However, drug interventions are currently ineffective in the prevention of dementia. Based on the synaptic plasticity, more and more studies focus on non-drug interventions. Our research group previously found 6-months non-drug interventions (cognitive training, exercise therapy) can effectively delay cognitive decline in the elderly, providing a new strategy for the improvement of cognition in the elderly. Therefore, this project plans to conduct a multi-site, randomized, parallel-controlled clinical trial to examine the effect of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Mild Cognitive Impairment
  • Tai Chi
03

In context

Cognitive Dysfunction

3,932 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's planned enrollment of 206 is above the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 668 studies on the registry; 377 are open to participants now.

Browse Ruijin Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female participants aged 55 to 85 years (inclusive) at the time of screening
  2. Willing and able to give informed consent by GCP and local guidance.
  3. Meets the National Institute on Aging of the National Institutes of Health and Alzheimer's Association (NIA-AA) diagnostic criteria for "Mild Cognitive Impairment Due to Alzheimer's Disease" (2011); does not meet the American Psychiatric Association's diagnostic criteria Diagnostic and Statistical Manual of Mental Disorders, Revised IV (DSM-IV-R) diagnostic criteria for dementia;
  4. Main complaint of memory loss, 24≤MMSE and/or 17≤MOCA\<26 points, with one or more cognitive domains impairments;
  5. CDR global score of 0.5, with memory box score ≥0.5
  6. Functional activities questionnaire (FAQ) \<5
  7. Hachinski ischemia score ≤4;
  8. Have the physical, cognitive, listening, speech, literacy and language skills necessary to participate in all tests;
  9. Capable of performing MR
  10. Allowed and Prohibited concomitant and treatments.

During the clinical study, the following drugs are prohibited:

Acetylcholinesterase inhibitors, N-methyl-D-aspartate (NMDA) antagonists (eg, memantine, amantadine, ketamine, and dextromethorphan), adrenal corticosteroids, central nervous system stimulants, traditional Chinese medicine and various medicines that can improve memory or cognition;

During the clinical study, the following drugs cannot be added:

Antipsychotics, antidepressants, sedative-hypnotics for sleep (zopiclone, alprazolam, estazolam can be used temporarily if necessary) For long-term use of the above drugs, the dose should be kept as stable as possible during the study.

Exclusion criteria

Exclusion Criteria

  1. Cognitive impairment caused by other reasons (for example) cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, dementia with Lewy bodies, trauma, other physical and chemical factors (drugs, alcohol, CO, etc.), important physical diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), brain tumor, endocrine diseases (thyroid disease, parathyroid disease), and vitamin deficiency or any other cause of dementia;
  2. Abnormal folate, thyroid, and/or vitamin B12 values that cannot be corrected before baseline visit.
  3. Major structural brain disease as judged by central MRI Diagnostic Imaging Review Team (eg, ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions. or a single lesion in a critical region [eg, thalamus]). Mild white matter changes without clinical significance and no more than 2 lacunar infarcts are permitted.
  4. Mental illness determined by Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria, that is unstable within 12 months, or would interfere with study assessments, including schizophrenia or other psychotic disorders, bipolar disorder, severe depression, or delirium.
  5. DSM V diagnosis of alcohol or other substance abuse dependence within the last 12 months.
  6. History or current diagnosis of significant cardiac arrhythmias, myocardial infarction, transient ischemic attack, or cerebrovascular accident, uncompensated congestive heart failure New York Heart Association class III and IV.
  7. Major medical illness or unstable medical condition within 6 months of screening that in the opinion of the investigator may interfere with the participant's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data, including any physical disability (eg. blindness. deafness, non-cognitive related speech impairment, sensory or motor dysfunction) that would prevent completion of study procedures or assessments.

  8. Cancer except:

    1. History of any cancer that has been in remission (no evidence of recurrence) for > 3 years from the screening
    2. Participants with basal cell or stage I squamous cell carcinoma of the skin, stable untreated cancer as prostate or meningioma.
  9. Exercise regularly within 6 months prior to screening.

  10. Participants are excluded if they

    1. have participated in any other clinical study within 4 weeks prior to screening visit
    2. have participated in another Tai chi clinical study at any time
    3. plan to take part in another clinical study during this study.
  11. Geriatric Depression Scale-15(GDS-15) total score > 7 at screening
  12. The researcher estimates that the subject's compliance is poor, and it is believed that the subject is unlikely to complete the study.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
206 participants (estimated)

Study arms

  • Experimental
    Tai chi training plus group activity

    Tai chi training: a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction. Group activity: a organizer will lead the subjects to participate in group activities, once per quarter.

    Behavioral: Tai chi training · Behavioral: Group activity

  • Other
    Only group activity

    Group activity: a organizer will lead the subjects to participate in group activities, once per quarter.

    Behavioral: Group activity

Interventions

  • BehavioralTai chi training

    Tai chi, also called tai chi chuan, is an ancient Chinese form of exercise originally created as a fighting art. It is a kind of gentle physical exercise and stretching, which involves a series of movements performed in a slow, focused manner and accompanied by deep breathing.

  • BehavioralGroup activity

    A organizer will lead the subjects to participate in group activities once a quarter. In group activities, there will be popular science lectures and interactive games.

06

What researchers measure

Primary outcomes

  1. Incidence of MCI converted to Alzheimer's disease.

    The 3-year incidence of AD in each group will be compared.

    Time frame: 36 months

  2. The global cognitive function of MCI patients.

    11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog 11) will be used to assess the global cognitive performance of MCI patients. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.

    Time frame: 18 months and 36 months

Secondary outcomes

  1. Memory

    Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).

    Time frame: 18 months and 36 months

  2. Attention

    Attention will be evaluated by Trial Making Test (TMT).

    Time frame: 18 months and 36 months

  3. Executive function

    Executive function will be evaluated by the Stroop task.

    Time frame: 18 months and 36 months

  4. Language

    Language will be assessed by Boston naming test (30-item version), and Verbal Fluency.

    Time frame: 18 months and 36 months

  5. Working memory test

    Working memory test will be assessed by Number Span Forward and Backward.

    Time frame: 18 months and 36 months

  6. Visual spatial ability

    Visual spatial ability will be assessed by Clock Drawing Test.

    Time frame: 18 months and 36 months

  7. Change from baseline in MMSE score

    Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome.

    Time frame: 18 months and 36 months

  8. Change from baseline in MoCA score

    Change from baseline in Montreal Cognitive Assessment (MoCA) score. The total score of MoCA is 0-30, with higher scores mean a better outcome.

    Time frame: 18 months and 36 months

  9. Change from baseline in CDR score

    Change from baseline in Clinical Dementia Rating (CDR) Scale score.

    Time frame: 18 months and 36 months

  10. Activities of daily living

    Activities of daily living will be assessed by functional activities questionnaire (FAQ). The total score of FAQ is 0-30, with higher scores mean a worse outcome.

    Time frame: 18 months and 36 months

  11. Anxiety

    Anxiety will be assessed by Hamilton Anxiety Rating Scale (HAMA).The total score of HAMA is 0-56, with higher scores mean a worse outcome.

    Time frame: 18 months and 36 months

  12. Depression

    Depression will be assessed by Hamilton Depression Rating Scale (HAMD).

    Time frame: 18 months and 36 months

  13. Sleep

    Sleep will be assessed by Pittsburgh Sleep Quality Index (PSQI).The total score of PSQI is 0-21, with higher scores mean a worse outcome.

    Time frame: 18 months and 36 months

  14. Brain activity

    Detecting changes associated with blood flow by fMRI.

    Time frame: 36 months

  15. Neurodegeneration in brain structures

    Brain atrophy will be assessed by Magnetic Resonance Volume Imaging.

    Time frame: 36 months

  16. Gut microbiota

    Gut microbiota will be assessed by 16S rRNA sequencing.

    Time frame: 18 months and 36 months

  17. Blood biomarkers

    Inflammatory factors (FGF basic、Eotaxin、G-CSF、GM-CSF、IFN-γ、IL-1β、IL-1ra、IL-2、IL-4、IL-5、IL-6、IL-7、IL-8、IL-9、IL-10、IL-12 (p70)、IL-13、IL-15、IL-17、IP-10、MCP-1 (MCAF)、MIP-1α、MIP-1β、PDGF-BB、RANTES、TNF-α、VEGF) will be measured by Bio-Plex Human Cytokine Assays.

    Time frame: 18 months and 36 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2022; primary completion for Sep 2026, 48 months later.

Of 1,439 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 48 months is above that.

Counting every sponsor, half of 1,512 studies reached it within 26 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2022
First posted
Apr 5, 2022
StartEst.
Sep 2022
Primary completionEst.
Sep 2026
CompletionEst.
Sep 2026
Last update
Aug 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05310890
Lead sponsor
Ruijin Hospital
Collaborators
Zhangjiagang Aoyang Hospital of Jiangsu Province
Responsible party
Shengdi Chen (Professor, Ruijin Hospital) — Principal investigator
First posted
Apr 5, 2022
Start date
Sep 2022 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Aug 1, 2022

Study contacts

Shengdi Chen, PhD
Contact
chensd@rjh.com.cn
86-21-6445-4473
Chao Gao, PhD
Contact
anshangaochao@163.com
86-18217590273

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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