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

Primary Purpose

Cognitive Decline, Cognitive Impairment, Aging

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Computerized cognitive training
Sponsored by
Science and Research Centre Koper
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Decline focused on measuring cognition, mobility, cognitive reserve, EEG/ERP

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Center for Daily Activity Koper (Slovenia)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Active control group

Arm Description

Participants in the intervention group received 24 sessions of computerized cognitive training, with a total time of 960 min.

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.

Outcomes

Primary Outcome Measures

Change in gait speed
The primary outcome is change in gait speed during single- and dual-task conditions from baseline to post-intervention.

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2018
Last Updated
March 1, 2019
Sponsor
Science and Research Centre Koper
Collaborators
University of Primorska, Albert Einstein College of Medicine, Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03860441
Brief Title
Effects of Cognitive Intervention on Cognition, Mobility and Brain Electrocortical Activity
Acronym
GIBKOP
Official Title
Holistic Approach for Active and Healthy Aging: Physical and Cognitive Activity, and Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Science and Research Centre Koper
Collaborators
University of Primorska, Albert Einstein College of Medicine, Vrije Universiteit Brussel

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Cognitive Impairment, Aging, Motor Coordination or Function
Keywords
cognition, mobility, cognitive reserve, EEG/ERP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants in the intervention group followed a computerized cognitive training program for 2-months, 3x/week, 40min/session
Masking
Participant
Masking Description
A single-blind randomized controlled trial
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in the intervention group received 24 sessions of computerized cognitive training, with a total time of 960 min.
Arm Title
Active control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Computerized cognitive training
Other Intervention Name(s)
cognitive remediation, cognitive training
Intervention Description
Intervention used CogniFit platform with Personalized brain training sub-option
Primary Outcome Measure Information:
Title
Change in gait speed
Description
The primary outcome is change in gait speed during single- and dual-task conditions from baseline to post-intervention.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Executive control (Trail-Making Task Forms A and B)
Description
Secondary outcome is change in executive control, measured with TMT A and B tests
Time Frame
up to 8 weeks
Title
Sensorimotor integration measured with EEG/ERP methodology
Description
Secondary outcome is change ERP components P1, N1, P2 and P3 (amplitudes and latencies)
Time Frame
up to 8 weeks
Title
Brain-derived neurotrophic factor (BDNF) extracted from peripheral blood sampling
Description
Secondary outcome is change in plasma BDNF plasma extraction evaluated in pg/mL
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
Center for Daily Activity Koper (Slovenia)
City
Koper
ZIP/Postal Code
6000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25938245
Citation
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.
Results Reference
background
PubMed Identifier
20643703
Citation
Verghese 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 Reference
result
PubMed Identifier
29680203
Citation
Marusic 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.
Results Reference
result

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

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