NCT04301960

Brief Summary

The aim of this study is to compare the effects of single and dual-task training on processing speed, cognitive functions, walking speed, dual-task performance and balance functions in individuals with mild cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

February 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

March 6, 2020

Last Update Submit

June 16, 2021

Conditions

Keywords

Single-taskDual-taskProcessing SpeedCognitive FunctionsWalking SpeedBalance Function

Outcome Measures

Primary Outcomes (1)

  • Choice Stepping Reaction Time Test (CSRT)

    A custom-made Choice Stepping Reaction Time step pad (CSRT-MAT) and a computer unit will be used to evaluate the processing speed. The system is consisted of a CSRT-MAT having pressure-sensitive panels and a display monitor connected to a computer unit. The computer unit recorded the timing of foot lift and landing. The step direction is indicated by one arrow changing its color. The CSRT device included 2 tests: Stepping Reaction Time (SRT) and Stroop Test (ST). In this study, only the SRT test will be done. In the SRT test, the participants are asked to step as quickly as possible onto the corresponding arrow on the CSRT-MAT and then return to the center. The reaction time (RT) measured from stimulus occurrence to movement initiation (lift off), movement time (MT) measured from movement initiation to step finalization (step down) and total response time (RsT) measured as the sum of RT and MT.

    8 weeks

Secondary Outcomes (8)

  • Stroop Test

    8 weeks

  • Verbal Fluency Test (VFT)

    8 weeks

  • Serial Subtraction Test (SST)

    8 weeks

  • 10 Meter Walking Test (10 MWT)

    8 weeks

  • 10 Meter Walking Test with Verbal Fluency Test (10 MWT-VFT)

    8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Single task group

EXPERIMENTAL

The single task group includes balance gaining and cognitive training. The single task group will have 30-40 minutes of single-task training for 3 sessions per week for 8 weeks.

Other: Single task training

Dual-task

EXPERIMENTAL

The dual-task group includes CSRT Mat training. The dual-task group will have CSRT Mat training for 30-40 minutes of dual-task training for 3 sessions per week for 8 weeks.

Other: Dual task training

Interventions

The single task group includes balance gaining and cognitive training. The single task group will have 30-40 minutes of single-task training for 3 sessions per week for 8 weeks.

Single task group

The dual-task group includes CSRT Mat training. The dual-task group will have CSRT Mat training for 30-40 minutes of dual-task training for 3 sessions per week for 8 weeks.

Dual-task

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participants who are between 65-85 years of age,
  • Who has the Montreal Cognitive Assessment score between 13-26,
  • Who has the Quick Mild Cognitive Impairment screen score between 48-67,
  • Who has Instrumental Activities of Daily Living Scale score ≥6/8,
  • Who says yes to "Do you have a memory problem?" question,
  • Who can walk independently without using any walking aids and
  • Who is likely to have mild cognitive impairment as a result of the tests will be referred to the neurologist and those whose diagnosis is confirmed will be included in this study.

You may not qualify if:

  • Participants who have any musculoskeletal disorders that may cause balance and gait disorders,
  • Who have central or peripheral neurological diseases (eg. stroke, Parkinson's disease or polyneuropathies),
  • Who are using psychiatric drugs that may affect psychiatric disease and/or cognitive performance,
  • Who has daltonism and
  • Who attends any exercise program will not be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, Eyalet/Yerleşke, 99450, Cyprus

Location

Related Publications (4)

  • Schoene D, Delbaere K, Lord SR. Impaired Response Selection During Stepping Predicts Falls in Older People-A Cohort Study. J Am Med Dir Assoc. 2017 Aug 1;18(8):719-725. doi: 10.1016/j.jamda.2017.03.010. Epub 2017 May 16.

    PMID: 28526585BACKGROUND
  • Faria CA, Alves HVD, Charchat-Fichman H. The most frequently used tests for assessing executive functions in aging. Dement Neuropsychol. 2015 Apr-Jun;9(2):149-155. doi: 10.1590/1980-57642015DN92000009.

    PMID: 29213956BACKGROUND
  • Iyigun G, Kirmizigil B, Angin E, Oksuz S, Can F, Eker L, Rose DJ. The reliability and validity of the Turkish version of Fullerton Advanced Balance (FAB-T) scale. Arch Gerontol Geriatr. 2018 Sep-Oct;78:38-44. doi: 10.1016/j.archger.2018.05.022. Epub 2018 Jun 4.

    PMID: 29886283BACKGROUND
  • Bilgin BF, Iyigun G. Multitask Versus Multicomponent Training on Cognitive and Motor Functions in Persons With Mild Cognitive Impairment: A Randomized Trial. J Aging Phys Act. 2022 Apr 20;30(6):1024-1037. doi: 10.1123/japa.2021-0408. Print 2022 Dec 1.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Betül Fatma Bilgin, PT

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Gözde İyigün, PhD

    Eastern Mediterranean University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

February 16, 2021

Primary Completion

June 16, 2021

Study Completion

June 16, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations