- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05485025
Long Term Prospective Study of Tai Chi Intervention to Delay the Progression of Subjective Cognitive Impairment (TIPS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai, China
- Shanghai Jiao Tong University School of Medicine affiliated Ruijin Hospital
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Contact:
- Shengdi Chen, Ph.D, MD
- Phone Number: 86-21-6445-4473
- Email: chensd@rjh.com.cn
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Contact:
- Chao Gao, Ph.D, MD
- Phone Number: 86-18217590273
- Email: anshangaochao@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Onset of SCI within the last 5 y
- Concerns (worries) associated with SCI
- Feeling of worse performance than others of the same age group
- Confirmation of cognitive decline by an informant.
- Have the physical, cognitive, listening, speech, literacy and language skills necessary to participate in all tests;
- Capable of performing MR.
Exclusion Criteria:
- 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;
- MOCA<26 points;
- CDR global score >0;
- Hachinski ischemia score >4;
During the clinical study, the following drugs are prohibited:
Acetylcholinesterase inhibitors, N-methyl-D-aspartate (NMDA) antagonists (eg, memantine), central nervous system stimulants, and various medicines that can improve memory or cognition; Antipsychotics
- 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.
- DSM V diagnosis of alcohol or other substance abuse dependence within the last 12 months.
- 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.
- 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.
Cancer except:
History of any cancer that has been in remission (no evidence of recurrence) for > 5 years from the screening Participants with basal cell or stage I squamous cell carcinoma of the skin, stable untreated cancer as prostate or meningioma.
- Active physical activity for 6 months prior to screening.
Participants are excluded if they
- have participated in any other clinical study within 4 weeks prior to screening visit
- have participated in another Tai chi clinical study at any time
- plan to take part in another clinical study during this study.
- The researcher estimates that the subject's compliance is poor, and it is believed that the subject is unlikely to complete the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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. |
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.
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EXPERIMENTAL: Only group activity
Group activity: a organizer will lead the subjects to participate in group activities, once per quarter.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The global cognitive function of SCI subjects.
Time Frame: 36 months
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Repeatable Battery for the Assessment of Neuropsychological Status(RBANS) will be used to assess the global cognitive performance of SCI subjects.
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Memory
Time Frame: 18 months and 36 months
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Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
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18 months and 36 months
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Attention
Time Frame: 18 months and 36 months
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Attention will be evaluated by Trial Making Test (TMT).
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18 months and 36 months
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Executive function
Time Frame: 18 months and 36 months
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Executive function will be evaluated by the Stroop task.
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18 months and 36 months
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Language
Time Frame: 18 months and 36 months
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Language will be assessed by Boston naming test (30-item version), and Verbal Fluency.
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18 months and 36 months
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Working memory test
Time Frame: 18 months and 36 months
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Working memory test will be assessed by Number Span Forward and Backward.
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18 months and 36 months
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Visual spatial ability
Time Frame: 18 months and 36 months
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Visual spatial ability will be assessed by Clock Drawing Test.
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18 months and 36 months
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Change from baseline in MoCA score
Time Frame: 18 months and 36 months
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Change from baseline in Montreal Cognitive Assessment (MoCA) score.
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18 months and 36 months
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Change from baseline in CDR score
Time Frame: 18 months and 36 months
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Change from baseline in Clinical Dementia Rating (CDR) Scale score.
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18 months and 36 months
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Activities of daily living
Time Frame: 18 months and 36 months
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Activities of daily living will be assessed by functional activities questionnaire (FAQ).
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18 months and 36 months
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Anxiety
Time Frame: 18 months and 36 months
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Anxiety will be assessed by Hamilton Anxiety Rating Scale (HAMA).
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18 months and 36 months
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Depression
Time Frame: 18 months and 36 months
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Depression will be assessed by Hamilton Depression Rating Scale (HAMD).
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18 months and 36 months
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Sleep
Time Frame: 18 months and 36 months
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Sleep will be assessed by Pittsburgh Sleep Quality Index (PSQI).
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18 months and 36 months
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Brain activity
Time Frame: 36 months
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Detecting changes associated with blood flow by fMRI.
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36 months
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Neurodegeneration in brain structures
Time Frame: 36 months
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Brain atrophy will be assessed by Magnetic Resonance Volume Imaging.
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36 months
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Gut microbiota
Time Frame: 18 months and 36 months
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Gut microbiota will be assessed by 16S rRNA sequencing.
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18 months and 36 months
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Blood biomarkers
Time Frame: 18 months and 36 months
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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
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18 months and 36 months
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Gait and Hand writing Task
Time Frame: 18 months and 36 months
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Using wearable sensors to assess gait and hand writing task.
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18 months and 36 months
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Incidence of SCI converted to MCI and Alzheimer's disease.
Time Frame: 36 months
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The 3-year incidence of MCI and AD in each group will be compared.
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36 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIPS Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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