NCT03860441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

October 2, 2018

Last Update Submit

March 1, 2019

Conditions

Cognitive DeclineCognitive ImpairmentAgingMotor Coordination or Function

Keywords

cognitionmobilitycognitive reserveEEG/ERP

Outcome Measures

Primary Outcomes (1)

  • Change in gait speed

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

    up to 8 weeks

Secondary Outcomes (3)

  • Executive control (Trail-Making Task Forms A and B)

    up to 8 weeks

  • Sensorimotor integration measured with EEG/ERP methodology

    up to 8 weeks

  • Brain-derived neurotrophic factor (BDNF) extracted from peripheral blood sampling

    up to 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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.

Other: Computerized cognitive training

Interventions

Computerized cognitive trainingOTHER

Intervention used CogniFit platform with Personalized brain training sub-option

Also known as: cognitive remediation, cognitive training
Active control groupIntervention group

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Daily Activity Koper (Slovenia)

Koper, 6000, Slovenia

Location

Related Publications (3)

  • 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.

    PMID: 25938245BACKGROUND

  • 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.

    PMID: 20643703RESULT

  • 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.

    PMID: 29680203RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive RemediationCognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A single-blind randomized controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants in the intervention group followed a computerized cognitive training program for 2-months, 3x/week, 40min/session
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

March 4, 2019

Study Start

July 1, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

SL(1)