Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment
NCT ID: NCT03119051
Last Updated: 2020-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2017-05-15
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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online cognitive training
Patients will receive 3-4 times of 20-30 minutes' training game every week
Online cognitive training
A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
no training
Patients will not undergo preoperative cognitive training.
No interventions assigned to this group
Cognitive training and physical exercise
Patients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training
Cognitive training plus physical exercise
Online cognitive training A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
Physical Exercise 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.
Interventions
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Online cognitive training
A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
Cognitive training plus physical exercise
Online cognitive training A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
Physical Exercise 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.
Eligibility Criteria
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Inclusion Criteria
* MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups\[1\];
* 24≤Mini-Mental State Examination (MMSE) ≤28；
* The Hamilton Depression Scale/17-item (HAMD) score ≤10;
* Not on medication for dementia;
* MRI T2 weighted image (T2WI) scan: aged ≤70 , Fazeca scale for White Matter lesions rating level≤1; \>70 years, white matter damage rating scale ≤2. The number of lacunar infarcts larger than 2 cm in diameter ≤2. No infarcts in hypothalamus, entorhinal cortex, para-hypothalamus, cortical and subcortical cavity infarction near gray matter nuclei. The medial temporal lobe atrophy (MTA) score: Grade II or above.
* Accompanied by reliable caregivers (at least intensive contact of 4 days every week and 2 hours every day) who are expected to participate in the follow-up visits and provide useful information for scores of scales like ADCS-ADL;
* Education level: primary school (grade 6) or above.
* Expected good compliance with the therapy and follow-up. Each patient gives a written informed consent, and the study has been approved by Ruijin Hospital's ethical committees.
Exclusion Criteria
* Medical history of other neurological disorders (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.);
* Psychiatric disorders defined by (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria;
* Unstable or severe disease of heart, lung, liver, kidney or hematopoietic system;
* History of alcohol or drug abuse;
* Participation in other clinical trial less than 30 days before the screening of this study;
* Inability to complete the study.
50 Years
85 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Huashan Hospital
OTHER
Ruijin Hospital
OTHER
Responsible Party
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Binyin Li
Principle Investigator
Principal Investigators
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Sheng-Di Chen
Role: STUDY_DIRECTOR
Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Locations
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Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Lin Y, Li B, Tang H, Xu Q, Wu Y, Cheng Q, Li C, Xiao S, Shen L, Tang W, Yu H, He N, Lin H, Yan F, Cao W, Yang S, Liu Y, Zhao W, Lu D, Jiao B, Xiao X, Zhou L, Chen S. Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology. BMC Neurol. 2018 Jul 24;18(1):103. doi: 10.1186/s12883-018-1100-x.
Other Identifiers
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RuijinHSH
Identifier Type: -
Identifier Source: org_study_id
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