Long Term Prospective Study of Tai Chi Intervention to Prevent MCI From Conversion to Dementia
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: Tai chi trainingBehavioral: Group activity
- Registration Number
- NCT05310890
- Lead Sponsor
- Ruijin Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 206
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tai chi training plus group activity 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. Only group activity Group activity Group activity: a organizer will lead the subjects to participate in group activities, once per quarter. Tai chi training plus group activity Tai chi training 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.
- Primary Outcome Measures
Name Time Method Incidence of MCI converted to Alzheimer's disease. 36 months The 3-year incidence of AD in each group will be compared.
The global cognitive function of MCI patients. 18 months and 36 months 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.
- Secondary Outcome Measures
Name Time Method Memory 18 months and 36 months Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
Attention 18 months and 36 months Attention will be evaluated by Trial Making Test (TMT).
Executive function 18 months and 36 months Executive function will be evaluated by the Stroop task.
Language 18 months and 36 months Language will be assessed by Boston naming test (30-item version), and Verbal Fluency.
Working memory test 18 months and 36 months Working memory test will be assessed by Number Span Forward and Backward.
Visual spatial ability 18 months and 36 months Visual spatial ability will be assessed by Clock Drawing Test.
Change from baseline in MMSE score 18 months and 36 months 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.
Change from baseline in MoCA score 18 months and 36 months Change from baseline in Montreal Cognitive Assessment (MoCA) score. The total score of MoCA is 0-30, with higher scores mean a better outcome.
Change from baseline in CDR score 18 months and 36 months Change from baseline in Clinical Dementia Rating (CDR) Scale score.
Activities of daily living 18 months and 36 months 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.
Anxiety 18 months and 36 months 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.
Depression 18 months and 36 months Depression will be assessed by Hamilton Depression Rating Scale (HAMD).
Sleep 18 months and 36 months 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.
Brain activity 36 months Detecting changes associated with blood flow by fMRI.
Neurodegeneration in brain structures 36 months Brain atrophy will be assessed by Magnetic Resonance Volume Imaging.
Gut microbiota 18 months and 36 months Gut microbiota will be assessed by 16S rRNA sequencing.
Blood biomarkers 18 months and 36 months 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.