This study evaluates the effects of 3 years-Tai Chi exercise intervention on cognitive function in subjects with subjective cognitive impairment (SCI). Participants will be randomized into the Tai chi training group and the control group.
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 (AD) 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. In recent years, studies have found that there is an earlier stage before MCI, that is, the stage of subjective cognitive impairment (SCI). SCI is a stage between normal aging and MCI, which is manifested by the self-reported experience of worsening or more frequent memory loss but not supported by objective evidence. Subjects with SCI are more likely to develop AD. According to the US CDC data, the prevalence of SCI among adults aged 65 years and older is 11.7%. Therefore, it is crucial to find intervention strategies to prevent the progression of SCI to MCI and dementia. However, drug interventions are currently ineffective in the prevention and treatment of such diseases. Based on the synaptic plasticity, more and more studies focus on non-drug interventions. Our research group previously found non-drug interventions (cognitive training, exercise therapy) can effectively delay cognitive decline 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 SCI subjects and to provide a new clinical basis for the prevention and treatment of cognitive disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
134
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.
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.
Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital
Shanghai, China
The global cognitive function of SCI subjects.
Repeatable Battery for the Assessment of Neuropsychological Status(RBANS) will be used to assess the global cognitive performance of SCI subjects.
Time frame: 36 months
Memory
Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
Time frame: 18 months and 36 months
Attention
Attention will be evaluated by Trial Making Test (TMT).
Time frame: 18 months and 36 months
Executive function
Executive function will be evaluated by the Stroop task.
Time frame: 18 months and 36 months
Language
Language will be assessed by Boston naming test (30-item version), and Verbal Fluency.
Time frame: 18 months and 36 months
Working memory test
Working memory test will be assessed by Number Span Forward and Backward.
Time frame: 18 months and 36 months
Visual spatial ability
Visual spatial ability will be assessed by Clock Drawing Test.
Time frame: 18 months and 36 months
Change from baseline in MoCA score
Change from baseline in Montreal Cognitive Assessment (MoCA) score.
Time frame: 18 months and 36 months
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Change from baseline in CDR score
Change from baseline in Clinical Dementia Rating (CDR) Scale score.
Time frame: 18 months and 36 months
Activities of daily living
Activities of daily living will be assessed by functional activities questionnaire (FAQ).
Time frame: 18 months and 36 months
Anxiety
Anxiety will be assessed by Hamilton Anxiety Rating Scale (HAMA).
Time frame: 18 months and 36 months
Depression
Depression will be assessed by Hamilton Depression Rating Scale (HAMD).
Time frame: 18 months and 36 months
Sleep
Sleep will be assessed by Pittsburgh Sleep Quality Index (PSQI).
Time frame: 18 months and 36 months
Brain activity
Detecting changes associated with blood flow by fMRI.
Time frame: 36 months
Neurodegeneration in brain structures
Brain atrophy will be assessed by Magnetic Resonance Volume Imaging.
Time frame: 36 months
Gut microbiota
Gut microbiota will be assessed by 16S rRNA sequencing.
Time frame: 18 months and 36 months
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. Nfl, Aβ40, Aβ42,T-tau, p-tau
Time frame: 18 months and 36 months
Gait and Hand writing Task
Using wearable sensors to assess gait and hand writing task.
Time frame: 18 months and 36 months
Incidence of SCI converted to MCI and Alzheimer's disease.
The 3-year incidence of MCI and AD in each group will be compared.
Time frame: 36 months