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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03860441
Other study ID # GIBKOP2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date September 30, 2018

Study information

Verified date March 2019
Source Science and Research Centre Koper
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 90 Years
Eligibility 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 Design


Intervention

Other:
Computerized cognitive training
Intervention used CogniFit platform with Personalized brain training sub-option

Locations

Country Name City State
Slovenia Center for Daily Activity Koper (Slovenia) Koper

Sponsors (4)

Lead Sponsor Collaborator
Science and Research Centre Koper Albert Einstein College of Medicine, University of Primorska, Vrije Universiteit Brussel

Country where clinical trial is conducted

Slovenia, 

References & Publications (3)

Marusic U, Kavcic V, Giordani B, Gerževic M, Meeusen R, Pišot 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. — View 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. Review. — View 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. — View Citation

Outcome

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