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The goal of this clinical trial is to investigate the possibility of rehabilitation of mild cognitive deficits in people with metabolic syndrome. We aim to implement a cognitive training program on patients with metabolic syndrome and cognitive deficits, and examine its effectiveness both post-intervention (3 months) and after 12 months.
Researchers will compare two groups, the experimental group that will receive the computerized cognitive training and the control group that will receive no training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized cognitive program | Experimental | 25 participants with metabolic syndrome and mild cognitive deficits; receive health advice using the World Health Organization's guidelines for Risk Reduction of Cognitive Decline and Dementia, and perform the computerized cognitive training program (BrainHQ) for 45 minutes per session, twice per week, over the 3-month intervention period. |
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| Control group | No Intervention | 25 participants with metabolic syndrome and mild cognitive deficits; receive health advice using the World Health Organization's guidelines for Risk Reduction of Cognitive Decline and Dementia. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized cognitive program | Other | BrainHQ was developed by Posit Science and includes computer-based brain-training exercises organized into six categories: Attention, Brain Speed, Memory, People Skills, Intelligence, and Navigation. Participants were instructed to perform a total of 24 sessions of computerized cognitive training at home, consisting of 45 minutes of training, twice per week, over a 3-month period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in scores of the Montreal Cognitive Assessment (MoCA) test | MoCA is a screening test for mild cognitive dysfunction; range 0-30, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| Change in scores of Complex Figure tests | Complex Figures assess visuo-constructional ability and visual memory; range 0-36, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R) | HVLT-R assesses verbal memory using a list of words; range 0-36 (immediate recall) and range 0-12 (delayed recall), higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| Change in scores of Digit Span test | Digit Span assesses working memory; range 0-14 (performance) and range 2-9 (span) for forward and backward condition, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| Change in scores of semantic Verbal Fluency test | Verbal Fluency assesses executive function that also relies on language component; higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| Change in scores of Flanker task | Flanker task assesses executive function and inhibition; range 0-48, higher scores represent better cognitive function |
| Measure | Description | Time Frame |
|---|---|---|
| Change in scores of Everyday Cognition-II (Ecog-II) | Ecog-II is a measure of everyday functioning that includes 41 items to assess memory, language, visual, spatial and perceptual abilities, planning, organization, and divided attention; higher scores represent worse everyday functioning | baseline, follow-up (1 year from baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina | Ioannina | 45110 | Greece |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| Change in scores of Continuous Performance Test (CPT) | CPT assesses executive function and inhibition; range 0-100, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| Change in scores of Set Shifting | Set Shifting assesses executive function and set-shifting; range 0-104, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| Change in scores of N-back | N-back assesses working memory; range 0-30, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |