Long Term Prospective Study of Tai Chi Intervention to Delay the Progression of Subjective Cognitive Impairment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorRuijin Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tai chi training

    Behavioral

    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.

  • Group activity

    Behavioral

    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.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Tai chi training plus group activityExperimental treatment 2 interventions
Group B: Only group activityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Other outcomes

Sponsors and contacts

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Ruijin Hospital

Lead sponsor

Zhangjiagang Aoyang Hospital of Jiangsu Province

Collaborator

This trial is not recruiting at the moment. You can still explore other options: