Effects of Cognitive Intervention on Cognition, Mobility and Brain Electrocortical Activity (GIBKOP)

March 1, 2019 updated by: Science and Research Centre Koper

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Koper, Slovenia, 6000
        • Center for Daily Activity Koper (Slovenia)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • younger than 60
  • smoking; regular alcohol consumption;
  • acute or chronic skeletal, neuromuscular, metabolic and cardiovascular disease condition;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants in the intervention group received 24 sessions of computerized cognitive training, with a total time of 960 min.
Other: Computerized cognitive training
Intervention used CogniFit platform with Personalized brain training sub-option
Other Names:
  • cognitive training
  • cognitive remediation
Active Comparator: Active control group
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.
Other: Computerized cognitive training
Intervention used CogniFit platform with Personalized brain training sub-option
Other Names:
  • cognitive training
  • cognitive remediation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive control (Trail-Making Task Forms A and B)
Time Frame: up to 8 weeks
Secondary outcome is change in executive control, measured with TMT A and B tests
up to 8 weeks
Sensorimotor integration measured with EEG/ERP methodology
Time Frame: up to 8 weeks
Secondary outcome is change ERP components P1, N1, P2 and P3 (amplitudes and latencies)
up to 8 weeks
Brain-derived neurotrophic factor (BDNF) extracted from peripheral blood sampling
Time Frame: up to 8 weeks
Secondary outcome is change in plasma BDNF plasma extraction evaluated in pg/mL
up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Science and Research Centre Koper

Collaborators

Albert Einstein College of Medicine
University of Primorska
Vrije Universiteit Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIBKOP2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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