Subjective Cognitive ImpairmentTIPSNCT05485025
Long Term Prospective Study of Tai Chi Intervention to Delay the Progression of Subjective Cognitive Impairment
A study testing Tai chi training and Group activity in people with Subjective Cognitive Impairment, run by Ruijin Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Subjective Cognitive Impairment
- What is being tested?
- Tai chi training and Group activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital
Shanghai
Shengdi Chen, Ph.D, MD, 86-21-6445-4473, chensd@rjh.com.cn
Chao Gao, Ph.D, MD, 86-18217590273, anshangaochao@163.com
About this study
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.
Read the 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 (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.
- Conditions
- Subjective Cognitive Impairment
- Being tested
- Tai chi training, Group activity
- Keywords
- subjective cognitive impairment, Tai Chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai chi trainingBehavioural
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 activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai chi training plus group activity | Experimental | 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. Receives: Behavioral: Tai chi training; Behavioral: Group activity |
| Only group activity | Experimental | Group activity: a organizer will lead the subjects to participate in group activities, once per quarter. Receives: Behavioral: Group activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (18)
Memory
Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
Measured: 18 months and 36 months
Attention
Attention will be evaluated by Trial Making Test (TMT).
Measured: 18 months and 36 months
Executive function
Executive function will be evaluated by the Stroop task.
Measured: 18 months and 36 months
Language
Language will be assessed by Boston naming test (30-item version), and Verbal Fluency.
Measured: 18 months and 36 months
Working memory test
Working memory test will be assessed by Number Span Forward and Backward.
Measured: 18 months and 36 months
Visual spatial ability
Visual spatial ability will be assessed by Clock Drawing Test.
Measured: 18 months and 36 months
Change from baseline in MoCA score
Change from baseline in Montreal Cognitive Assessment (MoCA) score.
Measured: 18 months and 36 months
Change from baseline in CDR score
Change from baseline in Clinical Dementia Rating (CDR) Scale score.
Measured: 18 months and 36 months
Activities of daily living
Activities of daily living will be assessed by functional activities questionnaire (FAQ).
Measured: 18 months and 36 months
Anxiety
Anxiety will be assessed by Hamilton Anxiety Rating Scale (HAMA).
Measured: 18 months and 36 months
Depression
Depression will be assessed by Hamilton Depression Rating Scale (HAMD).
Measured: 18 months and 36 months
Sleep
Sleep will be assessed by Pittsburgh Sleep Quality Index (PSQI).
Measured: 18 months and 36 months
Brain activity
Detecting changes associated with blood flow by fMRI.
Measured: 36 months
Neurodegeneration in brain structures
Brain atrophy will be assessed by Magnetic Resonance Volume Imaging.
Measured: 36 months
Gut microbiota
Gut microbiota will be assessed by 16S rRNA sequencing.
Measured: 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
Measured: 18 months and 36 months
Gait and Hand writing Task
Using wearable sensors to assess gait and hand writing task.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhangjiagang Aoyang Hospital of Jiangsu Province
- Responsible party
- Principal investigator, Shengdi Chen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485025
- Sponsor's protocol ID
- TIPS Study
- Acronym
- TIPS
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Prospective Study of Tai Chi Intervention to Delay the Progression of Subjective Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05485025
- Acronym / sponsor ID
- TIPS / TIPS Study
- Conditions
- Subjective Cognitive Impairment
- Keywords
- subjective cognitive impairment, Tai Chi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Zhangjiagang Aoyang Hospital of Jiangsu Province
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai chi training plus group activity | Experimental | Behavioral: Tai chi training, Behavioral: Group activityTai 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 | Experimental | Behavioral: Group activityGroup activity: a organizer will lead the subjects to participate in group activities, once per quarter. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Have the physical, cognitive, listening, speech, literacy and language skills necessary to participate in all tests;
- Capable of performing MR.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai chi trainingTai 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. | Behavioural | Tai chi training plus group activity |
| Group activityA 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. | Behavioural | Only group activity, Tai chi training plus group activity |
Primary outcome
The global cognitive function of SCI subjects.
Time frame: 36 months
Repeatable Battery for the Assessment of Neuropsychological Status(RBANS) will be used to assess the global cognitive performance of SCI subjects.
18 secondary outcomes
Memory
Time frame: 18 months and 36 months
Attention
Time frame: 18 months and 36 months
Executive function
Time frame: 18 months and 36 months
Language
Time frame: 18 months and 36 months
Working memory test
Time frame: 18 months and 36 months
Visual spatial ability
Time frame: 18 months and 36 months
Change from baseline in MoCA score
Time frame: 18 months and 36 months
Change from baseline in CDR score
Time frame: 18 months and 36 months
Activities of daily living
Time frame: 18 months and 36 months
Anxiety
Time frame: 18 months and 36 months
Depression
Time frame: 18 months and 36 months
Sleep
Time frame: 18 months and 36 months
Brain activity
Time frame: 36 months
Neurodegeneration in brain structures
Time frame: 36 months
Gut microbiota
Time frame: 18 months and 36 months
Blood biomarkers
Time frame: 18 months and 36 months
Gait and Hand writing Task
Time frame: 18 months and 36 months
Incidence of SCI converted to MCI and Alzheimer's disease.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai chi training and Group activity in people with Subjective Cognitive Impairment, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The global cognitive function of SCI subjects. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.