Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

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 Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Cognitive Deficit
• Intervention / Treatment: Other: Computerized cognitive program

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Ioánnina, Greece, 45110
    • Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized cognitive program; 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.	Other: Computerized 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University of Ioannina

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): March 20, 2025

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: metabolic syndrome; computerized cognitive rehabilitation; mild cognitive deficits
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Metabolic Diseases; Disease; Neurocognitive Disorders; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Cognitive Dysfunction; Metabolic Syndrome; Cognition Disorders
• Other Study ID Numbers: 27819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No