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Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

Primary Purpose

Metabolic Syndrome, Cognitive Deficit

Status

Recruiting

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Computerized cognitive program

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring metabolic syndrome, mild cognitive deficits, computerized cognitive rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Computerized cognitive program

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

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

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

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

Change in scores of Flanker task

Flanker task assesses executive function and inhibition; range 0-48, higher scores represent better cognitive function

Change in scores of Continuous Performance Test (CPT)

CPT assesses executive function and inhibition; range 0-100, higher scores represent better cognitive function

Change in scores of Set Shifting

Set Shifting assesses executive function and set-shifting; range 0-104, higher scores represent better cognitive function

Change in scores of N-back

N-back assesses working memory; range 0-30, higher scores represent better cognitive function

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05658354

First Posted

December 8, 2022

Last Updated

December 16, 2022

Sponsor

University of Ioannina

1. Study Identification

Unique Protocol Identification Number

NCT05658354

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Ioannina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Cognitive Deficit

Keywords

metabolic syndrome, mild cognitive deficits, computerized cognitive rehabilitation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Computerized cognitive program

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Computerized cognitive program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in scores of the Montreal Cognitive Assessment (MoCA) test

Description

MoCA is a screening test for mild cognitive dysfunction; range 0-30, higher scores represent better cognitive function

Time Frame