Metabolic SyndromeNCT05658354
Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits
A study testing Computerized cognitive program in people with Metabolic Syndrome and Cognitive Deficit, run by University of Ioannina at 1 site in Greece.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Cognitive Deficit
- What is being tested?
- Computerized cognitive program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2022to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of any serious neurological or psychiatric condition
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina
Ioannina, 45110
About this study
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
- Being tested
- Computerized cognitive program
- Keywords
- metabolic syndrome, mild cognitive deficits, computerized cognitive rehabilitation
- Medical subject headings
- Metabolic Syndrome, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, post-intervention (3 months), follow-up (1 year from baseline)
Secondary outcomes (1)
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
Measured: baseline, follow-up (1 year from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Dec 2022
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myrto Koutsonida, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658354
- Sponsor's protocol ID
- 27819
- Status last verified
- Jun 2025
- First submitted
- 8 Dec 2022
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits
- ClinicalTrials.gov ID
- NCT05658354
- Acronym / sponsor ID
- 27819
- Conditions
- Metabolic Syndrome, Cognitive Deficit
- Keywords
- metabolic syndrome, mild cognitive deficits, computerized cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized cognitive program | Experimental | Other: Computerized cognitive program25 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of any serious neurological or psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized cognitive programBrainHQ 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. | Other | Computerized cognitive program |
Primary outcome
Change in scores of the Montreal Cognitive Assessment (MoCA) test
Time frame: 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
Time frame: 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 Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: 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 Digit Span test
Time frame: 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
Time frame: 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
Time frame: 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 Continuous Performance Test (CPT)
Time frame: 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 Set Shifting
Time frame: 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
Time frame: 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
1 secondary outcome
Change in scores of Everyday Cognition-II (Ecog-II)
Time frame: baseline, follow-up (1 year from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive program in people with Metabolic Syndrome and Cognitive Deficit, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores of the Montreal Cognitive Assessment (MoCA) test (time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.