search
Back to results

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
Sponsored by
University of Ioannina
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
December 8, 2022
Last Updated
December 16, 2022
Sponsor
University of Ioannina
search

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
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
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Title
Change in scores of Complex Figure tests
Description
Complex Figures assess visuo-constructional ability and visual memory; range 0-36, higher scores represent better cognitive function
Time Frame
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Title
Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)
Description
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
Time Frame
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Title
Change in scores of Digit Span test
Description
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
Time Frame
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Title
Change in scores of semantic Verbal Fluency test
Description
Verbal Fluency assesses executive function that also relies on language component; higher scores represent better cognitive function
Time Frame
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Title
Change in scores of Flanker task
Description
Flanker task assesses executive function and inhibition; range 0-48, higher scores represent better cognitive function
Time Frame
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Title
Change in scores of Continuous Performance Test (CPT)
Description
CPT assesses executive function and inhibition; range 0-100, higher scores represent better cognitive function
Time Frame
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Title
Change in scores of Set Shifting
Description
Set Shifting assesses executive function and set-shifting; range 0-104, higher scores represent better cognitive function
Time Frame
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Title
Change in scores of N-back
Description
N-back assesses working memory; range 0-30, higher scores represent better cognitive function
Time Frame
baseline, post-intervention (3 months), follow-up (1 year from baseline)
Secondary Outcome Measure Information:
Title
Change in scores of Everyday Cognition-II (Ecog-II)
Description
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
Time Frame
baseline, follow-up (1 year from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos K Tsilidis, Associate Professor
Phone
26510 0 7734
Ext
0030
Email
ktsilidi@uoi.gr
Facility Information:
Facility Name
Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina
City
Ioánnina
ZIP/Postal Code
45110
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos K Tsilidis, Associate Professor
Phone
0030 26510 0 7734
Email
ktsilidi@uoi.gr
First Name & Middle Initial & Last Name & Degree
Konstantinos K Tsilidis, Associate Professor
First Name & Middle Initial & Last Name & Degree
Eleni Aretouli, Associate Professor
First Name & Middle Initial & Last Name & Degree
Myrto Koutsonida, PhD candidate

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

We'll reach out to this number within 24 hrs