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| Name | Class |
|---|---|
| Shanghai Sinopharm Nursing Care Center | UNKNOWN |
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This study is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease.
This is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease. Patients who eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into three groups by a 1:1:1 ratio. Patients in first arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. Patients in the second arm will receive intervention of exercise and cognitive training. Patients in the third arm will receive regular health advice. We hypothesize that the multi-domain intervention will reduce impairment in the study group compared to the control group during the 2-year intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-domain intervention group | Experimental | Patients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. |
|
| Exercise and cognitive training | Experimental | Patients in this arm will receive the intervention of exercise and cognitive training. |
|
| Standard health counseling at baseline | No Intervention | Patients in this arm will have their habitual diet and life style. No particular intervention or consultation would be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet intervention | Behavioral | Low inflammatory-index diet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline global cognitive function at one year | Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE) | One year |
| Change from baseline memory at one year | Change from baseline verbal memory using the Auditory verbal learning test (AVLT) | One year |
| Change from baseline visual spatial ability and visual memory at one year | Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT) | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test | Executive function | One year |
| Changes in hippocampus related neural circuit-specific resting-state connectivity (FC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binyin Li, Dr | Contact | 021-64370045 | lby11917@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200002 | China |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise |
| Behavioral |
Guided muscle strength training and stretching exercises |
|
| Cognitive training | Behavioral | Cognitive training will be implemented in person |
|
Neural connectivity by functional MRI |
| One year |
| Changes in structural brain MRI including volume of hippocampus and other specific brain regions | Brain structure by MRI | One year |
| Changes in Inflammatory biomarkers | Serum interleukins and tumor necrosis factors | One year |
| Changes in gut microbiota | Number of genera and abundance of microbiota in feces and blood | One year |
| Changes in Metabolic biomarkers | Low-density lipoprotein, high-density lipoprotein, and total cholesterol | One year |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |