Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

NCT05658354 | Completed

• 1 other identifier: 27819
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Cognitive Deficit

Keywords

metabolic syndrome; mild cognitive deficits; computerized cognitive rehabilitation

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Change in scores of Everyday Cognition-II (Ecog-II)

  baseline, follow-up (1 year from baseline)

Study Arms (2)

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.

Other: Computerized cognitive program

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.

Interventions

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.

Computerized cognitive program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of any serious neurological or psychiatric condition

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina

Ioannina, 45110, Greece

Location

MeSH Terms

Conditions

Metabolic Syndrome; Cognition Disorders

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 20, 2022
• Study Start: December 1, 2022
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)