About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants aged 60 to 75 years (inclusive) at the time of screening;
Willing and able to give informed consent by GCP and local guidance;
Meets the diagnostic criteria for subjective cognitive impairment (SCI) and the following criteria
Subjective decline in memory, rather than other domains of cognition
Disqualifiers
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;
Abnormal folate, thyroid, and/or vitamin B12 values that cannot be corrected before baseline visit;
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;
Geriatric Depression Scale-15(GDS-15) total score > 7 at screening;
Trial design
Parallel
Treatments tested in this trial
Tai chi training
BehavioralTai 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.
Group activity
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Memory
Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
Attention
Attention will be evaluated by Trial Making Test (TMT).
Executive function
Executive function will be evaluated by the Stroop task.
Language
Language will be assessed by Boston naming test (30-item version), and Verbal Fluency.
Sponsors and contacts
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Ruijin Hospital
Lead sponsor
Zhangjiagang Aoyang Hospital of Jiangsu Province
Collaborator
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