NCT05855785

Brief Summary

The purpose of this study is to investigate the effect of the dual task exercise program on cognitive and physical function in the elderly with mild cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

March 30, 2023

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Dual task cost in Timed up and go (TUG)

    Participants completed both single-task (ST) and dual-task (DT) tests at baseline and post-intervention. For a ST condition, participants performed motor task only such as Timed up and go (TUG). TUG measured the time of taking to rise from a chair, walking three meters, turning around 180 degrees, walking back to the chair, and sitting down while turning 180 degrees. For a DT condition, participants performed TUG while performing serial 3 simultaneously. Serial 3 is descending subtraction task, where the patient counts down from one hundred by threes. In the DT condition, participants were given no instruction regarding the prioritization of one task over the other. We calculated TUG duration in both conditions. Dual task cost(DTC) were calculated as a percentage as follows: (%DTC) = \[dual task duration or speed - single task duration or speed\] / \[single task duration or speed\] \* 100%. The lower DTC indicates efficiency in cognitive-motor interplay and good dual task ability.

    Baseline

  • Dual task cost in 10-meter walking test

    Participants completed both single-task (ST) and dual-task (DT) tests at baseline and post-intervention. For a ST condition, participants performed motor task only such as 10-meter walking test (10MWT). 10MWT is a performance measure used to assess walking speed over a short distance. For a DT condition, participants performed 10MWT while performing serial 3 simultaneously. Serial 3 is descending subtraction task, where the patient counts down from one hundred by threes. In the DT condition, participants were given no instruction regarding the prioritization of one task over the other. We calculated 10MWT gait speed in both conditions. Dual task cost(DTC) were calculated as a percentage as follows: (%DTC) = \[dual task duration or speed - single task duration or speed\] / \[single task duration or speed\] \* 100%. The lower DTC indicates efficiency in cognitive-motor interplay and good dual task ability.

    Baseline

  • Dual task cost in Timed up and go (TUG)

    Participants completed both single-task (ST) and dual-task (DT) tests at baseline and post-intervention. For a ST condition, participants performed motor task only such as Timed up and go (TUG). TUG measured the time of taking to rise from a chair, walking three meters, turning around 180 degrees, walking back to the chair, and sitting down while turning 180 degrees. For a DT condition, participants performed TUG while performing serial 3 simultaneously. Serial 3 is descending subtraction task, where the patient counts down from one hundred by threes. In the DT condition, participants were given no instruction regarding the prioritization of one task over the other. We calculated TUG duration in both conditions. Dual task cost(DTC) were calculated as a percentage as follows: (%DTC) = \[dual task duration or speed - single task duration or speed\] / \[single task duration or speed\] \* 100%. The lower DTC indicates efficiency in cognitive-motor interplay and good dual task ability.

    immediately after the 8-week intervention

  • Dual task cost in 10-meter walking test

    Participants completed both single-task (ST) and dual-task (DT) tests at baseline and post-intervention. For a ST condition, participants performed motor task only such as 10-meter walking test (10MWT). 10MWT is a performance measure used to assess walking speed over a short distance. For a DT condition, participants performed 10MWT while performing serial 3 simultaneously. Serial 3 is descending subtraction task, where the patient counts down from one hundred by threes. In the DT condition, participants were given no instruction regarding the prioritization of one task over the other. We calculated 10MWT gait speed in both conditions. Dual task cost(DTC) were calculated as a percentage as follows: (%DTC) = \[dual task duration or speed - single task duration or speed\] / \[single task duration or speed\] \* 100%. The lower DTC indicates efficiency in cognitive-motor interplay and good dual task ability.

    immediately after the 8-week intervention

Secondary Outcomes (30)

  • Korean Montreal Cognitive Assessment (MoCA-K)

    Baseline

  • Korean Montreal Cognitive Assessment (MoCA-K)

    immediately after the 8-week intervention

  • Korean Mini Mental Status Examination (K-MMSE)

    Baseline

  • Korean Mini Mental Status Examination (K-MMSE)

    immediately after the 8-week intervention

  • Computerized cognitive test(digit span test, visual learning test, verbal learning test, the Stroop Color and Word test, Boston naming test, trail making test, and verbal fluency test)

    Baseline

  • +25 more secondary outcomes

Study Arms (2)

The exercise group

EXPERIMENTAL

The exercise group underwent 8-week, 3 times a week, 60-minute group exercise sessions, which were comprised of moderate-to-high intensity exercise and simultaneous cognitive tasks. The exercise group also performed moderate-intensity home aerobic exercises for at least 60 minutes per week.

Behavioral: dual task exercise

The control group

OTHER

The control group performed 60-minute light intensity home exercise, 4 times a week for 8 weeks.

Behavioral: home exercise

Interventions

8-week, 3 times a week, 60-minute group exercise sessions, which were comprised of moderate-to-high intensity exercise and simultaneous cognitive tasks

The exercise group
home exerciseBEHAVIORAL

60-minute light intensity home exercise, 4 times a week for 8 weeks

The control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • a score on the Korean Montreal Cognitive Assessment (MoCA-K) of 25 points or below
  • aged 65 or more
  • no physical or medical problem which impairs moderate to vigorous physical activity

You may not qualify if:

  • uncontrolled or unstable cardiovascular disease
  • malignancy affecting general condition
  • musculoskeletal problems affecting motor performance
  • speech and hearing impairment
  • other organic brain diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Related Publications (1)

  • Plummer P, Eskes G. Measuring treatment effects on dual-task performance: a framework for research and clinical practice. Front Hum Neurosci. 2015 Apr 28;9:225. doi: 10.3389/fnhum.2015.00225. eCollection 2015.

    PMID: 25972801BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Se Hee Jung, MD, PhD

    Department of Rehabilitation Medicine, Seoul National University Boramae Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 11, 2023

Study Start

May 1, 2020

Primary Completion

September 30, 2020

Study Completion

April 8, 2021

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations