Cognitive Deficit, Metabolic Syndrome
Conditions
Keywords
metabolic syndrome, mild cognitive deficits, computerized cognitive rehabilitation
Brief summary
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.
Interventions
OTHERComputerized cognitive program
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.
Sponsors
University of Ioannina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Presence of metabolic syndrome according to the criteria of IDF (2005) or revised NCEP-ATP III (2005) * Presence of mild cognitive deficit (-1.5 SD below age and education-adjusted normative mean) in previously administered neuropsychological tests of Trail Making test (Part A & B), Verbal Fluency test (animals and letter x), Logical Memory test (immediate and delayed recall) * Written informed consent to participate
Exclusion criteria
* Presence of any serious neurological or psychiatric condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores of Set Shifting | baseline, post-intervention (3 months), follow-up (1 year from baseline) | Set Shifting assesses executive function and set-shifting; range 0-104, higher scores represent better cognitive function |
| Change in scores of N-back | baseline, post-intervention (3 months), follow-up (1 year from baseline) | N-back assesses working memory; range 0-30, higher scores represent better cognitive function |
| Change in scores of the Montreal Cognitive Assessment (MoCA) test | baseline, post-intervention (3 months), follow-up (1 year from baseline) | MoCA is a screening test for mild cognitive dysfunction; range 0-30, higher scores represent better cognitive function |
| Change in scores of Complex Figure tests | baseline, post-intervention (3 months), follow-up (1 year from baseline) | Complex Figures assess visuo-constructional ability and visual memory; range 0-36, higher scores represent better cognitive function |
| Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R) | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 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 |
| Change in scores of Digit Span test | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 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 |
| Change in scores of semantic Verbal Fluency test | baseline, post-intervention (3 months), follow-up (1 year from baseline) | Verbal Fluency assesses executive function that also relies on language component; higher scores represent better cognitive function |
| Change in scores of Flanker task | baseline, post-intervention (3 months), follow-up (1 year from baseline) | Flanker task assesses executive function and inhibition; range 0-48, higher scores represent better cognitive function |
| Change in scores of Continuous Performance Test (CPT) | baseline, post-intervention (3 months), follow-up (1 year from baseline) | CPT assesses executive function and inhibition; range 0-100, higher scores represent better cognitive function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores of Everyday Cognition-II (Ecog-II) | baseline, follow-up (1 year from baseline) | 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 |
Countries
Greece
Outcome results
None listed