Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome; Cognitive Deficit
• Interventions: Other: Computerized cognitive program

• Registration Number: NCT05658354
• Lead Sponsor: University of Ioannina

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-01
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-16
• Last Update Submitted: 2022-12-16
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized cognitive program	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.

Primary Outcome Measures

Name	Time	Method
Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)	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	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	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)	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Change in scores of Everyday Cognition-II (Ecog-II)	baseline, follow-up (1 year from baseline)	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

Trial Locations

Locations (1)

Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina; 🇬🇷 Ioánnina, Greece