Cognitive DeclineGIBKOPNCT03860441
Effects of Cognitive Intervention on Cognition, Mobility and Brain Electrocortical Activity
A study testing Computerized cognitive training in people with Cognitive Decline and Cognitive Impairment, run by Science and Research Centre Koper at 1 site in Slovenia.
Trial summary
Within this project the investigators tested the effectiveness of 2-month of computerized cognitive training (CCT) on CogniFit online platform on 77 older adults, which were randomly divided into intervention and control group. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Impairment, Aging
- What is being tested?
- Computerized cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jul 2017to 30 Sep 2018
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- active and healthy older adults with no major health issues
- members of the Center for Daily Activity Koper (Slovenia)
- had normal or corrected-to-normal vision;
- reported no history of cardiovascular, neurological, or psychiatric conditions
Who cannot join
- younger than 60
- smoking; regular alcohol consumption;
- acute or chronic skeletal, neuromuscular, metabolic and cardiovascular disease condition;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Holistic Approach for Active and Healthy Aging: Physical and Cognitive Activity, and Nutrition
Within this project the investigators tested the effectiveness of 2-month of computerized cognitive training (CCT) on CogniFit online platform on 77 older adults, which were randomly divided into intervention and control group. The investigators tested close (battery of cognitive functions) and far transfer (postural and mobility control, EEG, blood samples) of the CCT. Additionally, the investigators were interested into seeing a long-lasting effect, therefore participants were brought back to the laboratory 1 year post CCT.
- Being tested
- Computerized cognitive training
- Keywords
- cognition, mobility, cognitive reserve, EEG/ERP
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive trainingOther
Also called cognitive remediation, cognitive training
Intervention used CogniFit platform with Personalized brain training sub-option
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group received 24 sessions of computerized cognitive training, with a total time of 960 min. Receives: Other: Computerized cognitive training |
| Active control group | Active comparator | Participants in the control group attended activities separate activities, such as learning about healthy lifestyle, had cooking and other social lessons for the same amount as the intervention group performed cognitive training. Receives: Other: Computerized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed
The primary outcome is change in gait speed during single- and dual-task conditions from baseline to post-intervention.
Measured: up to 8 weeks
Secondary outcomes (3)
Executive control (Trail-Making Task Forms A and B)
Secondary outcome is change in executive control, measured with TMT A and B tests
Measured: up to 8 weeks
Sensorimotor integration measured with EEG/ERP methodology
Secondary outcome is change ERP components P1, N1, P2 and P3 (amplitudes and latencies)
Measured: up to 8 weeks
Brain-derived neurotrophic factor (BDNF) extracted from peripheral blood sampling
Secondary outcome is change in plasma BDNF plasma extraction evaluated in pg/mL
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 Jul 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the intervention group followed a computerized cognitive training program for 2-months, 3x/week, 40min/session
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- University of Primorska, Albert Einstein College of Medicine, Vrije Universiteit Brussel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860441
- Sponsor's protocol ID
- GIBKOP2017
- Acronym
- GIBKOP
- Status last verified
- Mar 2019
- First submitted
- 2 Oct 2018
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marusic U, Kavcic V, Giordani B, Gerzevic M, Meeusen R, Pisot R. Computerized spatial navigation training during 14 days of bed rest in healthy older adult men: Effect on gait performance. Psychol Aging. 2015 Jun;30(2):334-340. doi: 10.1037/pag0000021. Epub 2015 May 4.
PubMed 25938245Verghese J, Mahoney J, Ambrose AF, Wang C, Holtzer R. Effect of cognitive remediation on gait in sedentary seniors. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1338-43. doi: 10.1093/gerona/glq127. Epub 2010 Jul 19.
PubMed 20643703Marusic U, Verghese J, Mahoney JR. Cognitive-Based Interventions to Improve Mobility: A Systematic Review and Meta-analysis. J Am Med Dir Assoc. 2018 Jun;19(6):484-491.e3. doi: 10.1016/j.jamda.2018.02.002. Epub 2018 Apr 19.
PubMed 29680203
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Approach for Active and Healthy Aging: Physical and Cognitive Activity, and Nutrition
- ClinicalTrials.gov ID
- NCT03860441
- Acronym / sponsor ID
- GIBKOP / GIBKOP2017
- Keywords
- cognition, mobility, cognitive reserve, EEG/ERP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- University of Primorska, Albert Einstein College of Medicine, Vrije Universiteit Brussel
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 4 Mar 2019 (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.
Within this project the investigators tested the effectiveness of 2-month of computerized cognitive training (CCT) on CogniFit online platform on 77 older adults, which were randomly divided into intervention and control group. The investigators tested close (battery of cognitive functions) and far transfer (postural and mobility control, EEG, blood samples) of the CCT. Additionally, the investigators were interested into seeing a long-lasting effect, therefore participants were brought back to the laboratory 1 year post CCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants in the intervention group followed a computerized cognitive training program for 2-months, 3x/week, 40min/session
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Computerized cognitive trainingParticipants in the intervention group received 24 sessions of computerized cognitive training, with a total time of 960 min. |
| Active control group | Active comparator | Other: Computerized cognitive trainingParticipants in the control group attended activities separate activities, such as learning about healthy lifestyle, had cooking and other social lessons for the same amount as the intervention group performed cognitive training. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- active and healthy older adults with no major health issues
- members of the Center for Daily Activity Koper (Slovenia)
- had normal or corrected-to-normal vision;
- reported no history of cardiovascular, neurological, or psychiatric conditions
Key exclusion criteria (3 listed)
- younger than 60
- smoking; regular alcohol consumption;
- acute or chronic skeletal, neuromuscular, metabolic and cardiovascular disease 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 trainingAlso: cognitive remediation, cognitive trainingIntervention used CogniFit platform with Personalized brain training sub-option | Other | Active control group, Intervention group |
Primary outcome
Change in gait speed
Time frame: up to 8 weeks
The primary outcome is change in gait speed during single- and dual-task conditions from baseline to post-intervention.
3 secondary outcomes
Executive control (Trail-Making Task Forms A and B)
Time frame: up to 8 weeks
Sensorimotor integration measured with EEG/ERP methodology
Time frame: up to 8 weeks
Brain-derived neurotrophic factor (BDNF) extracted from peripheral blood sampling
Time frame: up to 8 weeks
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 5 Mar 2019.
- Background: PubMed 25938245Marusic U, Kavcic V, Giordani B, Gerzevic M, Meeusen R, Pisot R. Computerized spatial navigation training during 14 days of bed rest in healthy older adult men: Effect on gait performance. Psychol Aging. 2015 Jun;30(2):334-340. doi: 10.1037/pag0000021. Epub 2015 May 4.
- Results publication: PubMed 20643703Verghese J, Mahoney J, Ambrose AF, Wang C, Holtzer R. Effect of cognitive remediation on gait in sedentary seniors. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1338-43. doi: 10.1093/gerona/glq127. Epub 2010 Jul 19.
- Results publication: PubMed 29680203Marusic U, Verghese J, Mahoney JR. Cognitive-Based Interventions to Improve Mobility: A Systematic Review and Meta-analysis. J Am Med Dir Assoc. 2018 Jun;19(6):484-491.e3. doi: 10.1016/j.jamda.2018.02.002. Epub 2018 Apr 19.
- Individual participant dataSharing planned: Undecided
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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 training in people with Cognitive Decline and Cognitive Impairment, run by Science and Research Centre Koper at 1 site in Slovenia.
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 3 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 5 Mar 2019. 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 Slovenia. 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 gait speed (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860441, which also lists 3 linked publications.
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 5 Mar 2019.