Clinical trial NCT05658354: Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits
Official title: Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Cognitive Deficit
Keywords: metabolic syndrome
mild cognitive deficits
computerized cognitive rehabilitation
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in scores of the Montreal Cognitive Assessment (MoCA) test
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
measure: Change in scores of Complex Figure tests
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
measure: Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
measure: Change in scores of Digit Span test
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
measure: Change in scores of semantic Verbal Fluency test
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
measure: Change in scores of Flanker task
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
measure: Change in scores of Continuous Performance Test (CPT)
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
measure: Change in scores of Set Shifting
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
measure: Change in scores of N-back
timeFrame: baseline, post-intervention (3 months), follow-up (1 year from baseline)
Secondary outcomes:
measure: Change in scores of Everyday Cognition-II (Ecog-II)
timeFrame: baseline, follow-up (1 year from baseline)
Other outcomes:
Locations:
city: Ioánnina
country: Greece
facility: Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina
Study officials:
References: