Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ioannina
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)
Time Frame: 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 the Montreal Cognitive Assessment (MoCA) test
Time Frame: 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
Time Frame: 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 Continuous Performance Test (CPT)
Time Frame: 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
Change in scores of Digit Span test
Time Frame: 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
Time Frame: 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
Time Frame: 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 Set Shifting
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- Change in scores of Everyday Cognition-II (Ecog-II)(baseline, follow-up (1 year from baseline))
Investigators
Myrto Koutsonida
PhD candidate
University of Ioannina