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Cognitive DysfunctionNCT05855785

Effect of Dual Task Exercise on Cognitive and Physical Function in the Elderly With Mild Cognitive Impairment

A study testing dual task exercise and home exercise in people with Cognitive Dysfunction and Mild Cognitive Impairment, run by Seoul National University Boramae Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
dual task exercise and home exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSouth Korea
Study dates
1 May 2020to 8 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Seoul National University Boramae Medical Center

    Seoul, 07061

Other trials in South Korea

About this study

Official title: Effect of Dual-task Exercise on Cognitive and Physical Function in the Elderly With Mild Cognitive Impairment: a Randomized Controlled Trial

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.

Read the detailed description

All participants provided written informed consent before study participation. A total of 12 community-dwelling participants were randomized either to the exercise group or to the control group.

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. They also performed moderate-intensity home aerobic exercises for at least 60 minutes per week. The control group performed 60-minute light intensity home exercise, 4 times a week for 8 weeks.

Being tested
dual task exercise, home exercise
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dual task exerciseBehavioural

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

  • home exerciseBehavioural

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

Study groups in NCT05855785
Study groupRoleWhat they receive
The exercise groupExperimentalThe 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.
Receives: Behavioral: dual task exercise
The control groupOtherThe control group performed 60-minute light intensity home exercise, 4 times a week for 8 weeks.
Receives: Behavioral: home exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: immediately after the 8-week intervention

  4. 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.

    Measured: immediately after the 8-week intervention

Secondary outcomes (30)
  1. Korean Montreal Cognitive Assessment (MoCA-K)

    MoCA-K is a screening test to assess cognitive functions such as attention, concentration, execution, memory, vocabulary, visual space, abstraction, and calculation. MoCA-K is a test for mild cognitive impairment and it takes about 10 minutes to run. It assesses cognitive functions such as attention, concentration, execution, memory, vocabulary, visual space, abstraction, calculation and support. Of a maximum 30 points, a score of 25 or higher is considered normal.

    Measured: Baseline

  2. Korean Montreal Cognitive Assessment (MoCA-K)

    MoCA-K is a screening test to assess cognitive functions such as attention, concentration, execution, memory, vocabulary, visual space, abstraction, and calculation. MoCA-K is a test for mild cognitive impairment and it takes about 10 minutes to run. It assesses cognitive functions such as attention, concentration, execution, memory, vocabulary, visual space, abstraction, calculation and support. Of a maximum 30 points, a score of 25 or higher is considered normal.

    Measured: immediately after the 8-week intervention

  3. Korean Mini Mental Status Examination (K-MMSE)

    K-MMSE is a screening test for dementia that can evaluate various areas of cognitive function in a short time of 5 to 10 minutes such as time orientation, place orientation, memory, attention and calculation, understanding and judgment, and language. Of a maximum 30 points, a score of less than 24 is considered dementia.

    Measured: Baseline

  4. Korean Mini Mental Status Examination (K-MMSE)

    K-MMSE is a screening test for dementia that can evaluate various areas of cognitive function in a short time of 5 to 10 minutes such as time orientation, place orientation, memory, attention and calculation, understanding and judgment, and language. Of a maximum 30 points, a score of less than 24 is considered dementia.

    Measured: immediately after the 8-week intervention

  5. 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)

    Computerized cognitive test is a test method which quantitatively measures patients' cognitive problems in a systematic and standardized manner using a computer. Various neurocognitive function tests such as attention, memory, memory-motor coordination, and comprehensive cognitive thinking ability are possible through computerized cognitive test. Card sorting test, digit span test, visual learning test, verbal learning test, and Stroop word color test were conducted for precise cognitive function evaluation.

    Measured: Baseline

  6. 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)

    Computerized cognitive test is a test method which quantitatively measures patients' cognitive problems in a systematic and standardized manner using a computer. Various neurocognitive function tests such as attention, memory, memory-motor coordination, and comprehensive cognitive thinking ability are possible through computerized cognitive test. Card sorting test, digit span test, visual learning test, verbal learning test, and Stroop word color test were conducted for precise cognitive function evaluation.

    Measured: immediately after the 8-week intervention

  7. Short Physical Performance Battery (SPPB)

    SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people . The scores range from 0 (worst performance) to 12 (best performance).

    Measured: Baseline

  8. Short Physical Performance Battery (SPPB)

    SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people . The scores range from 0 (worst performance) to 12 (best performance).

    Measured: immediately after the 8-week intervention

  9. Berg Balance Scale (BBS)

    BBS is an evaluation tool designed to measure the balance of the elderly and consists of 56 points in 14 items that apply daily life movements. It is a measure to objectively evaluate static and dynamic balance ability in various postures such as sitting, standing, and posture change. Higher score means well balance function.

    Measured: Baseline

  10. Berg Balance Scale (BBS)

    BBS is an evaluation tool designed to measure the balance of the elderly and consists of 56 points in 14 items that apply daily life movements. It is a measure to objectively evaluate static and dynamic balance ability in various postures such as sitting, standing, and posture change. Higher score means well balance function.

    Measured: immediately after the 8-week intervention

  11. Falls Efficacy Scale (FES)

    FES is a questionnaire that evaluates the confidence to perform the activities without falling from the 10 activities. Higher score means good function.

    Measured: Baseline

  12. Falls Efficacy Scale (FES)

    FES is a questionnaire that evaluates the confidence to perform the activities without falling from the 10 activities. Higher score means good function.

    Measured: immediately after the 8-week intervention

  13. Activities-specific Balance Confidence (ABC)

    ABC consists of 16 surveys and it evaluates level of self-confidence in doing the activity without losing balance or becoming unsteady by choosing one of the percentage points on the scale from 0% to 100%.

    Measured: Baseline

  14. Activities-specific Balance Confidence (ABC)

    ABC consists of 16 surveys and it evaluates level of self-confidence in doing the activity without losing balance or becoming unsteady by choosing one of the percentage points on the scale from 0% to 100%.

    Measured: immediately after the 8-week intervention

  15. Grip strength

    Grip strength was measured by hand dynamometer for evaluating muscle strength. It is measured using pound(lb).

    Measured: Baseline

  16. Grip strength

    Grip strength was measured by hand dynamometer for evaluating muscle strength. It is measured using pound(lb).

    Measured: immediately after the 8-week intervention

  17. Korean version of Physical Activity Scale for the Elderly (K-PASE)

    K-PASE measures various physical activities of the elderly which are divided into sedentary life, leisure time activities, housework activities, and work-related activities. The score is calculated by multiplying the level and frequency of each activity using the conversion table. Higher score means higher activity.

    Measured: Baseline

  18. Korean version of Physical Activity Scale for the Elderly (K-PASE)

    K-PASE measures various physical activities of the elderly which are divided into sedentary life, leisure time activities, housework activities, and work-related activities. The score is calculated by multiplying the level and frequency of each activity using the conversion table. Higher score means higher activity.

    Measured: during intervention(8 weeks)

  19. International Physical Activity Questionnaires Short form (IPAQ)

    IPAQ Short form consists of 7 surveys and evaluate the degree of physical activity and the time spent on physical activity for one week.

    Measured: Baseline

  20. International Physical Activity Questionnaires Short form (IPAQ)

    IPAQ Short form consists of 7 surveys and evaluate the degree of physical activity and the time spent on physical activity for one week.

    Measured: during intervention (8 weeks)

  21. Metabolic Equivalent Task (MET) minutes per week

    MET minutes per week were evaluated to measure the degree of physical activity before intervention and every week during 8 weeks of intervention. MET minutes per week was calculated based on IPAQ.

    Measured: Baseline

  22. Metabolic Equivalent Task (MET) minutes per week

    MET minutes per week were evaluated to measure the degree of physical activity before intervention and every week during 8 weeks of intervention. MET minutes per week was calculated based on IPAQ.

    Measured: during intervention(8 weeks)

  23. Bioelectrical Impedance Analysis

    Bioelectrical Impedance Analysis was evaluated using Inbody for changes in body composition before and after intervention. Specifically, body weight, body fat percent, body mass index (BMI), skeletal muscle mass, lean mass, fat mass, waist hip ratio were evaluated.

    Measured: Baseline

  24. Bioelectrical Impedance Analysis

    Bioelectrical Impedance Analysis was evaluated using Inbody for changes in body composition before and after intervention. Specifically, body weight, body fat percent, body mass index (BMI), skeletal muscle mass, lean mass, fat mass, waist hip ratio were evaluated.

    Measured: immediately after the 8-week intervention

  25. Exercise Identity Scale (EIS)

    Exercise Identity Scale (EIS) is a measure of how important exercise is in daily life

    Measured: Baseline

  26. Exercise Identity Scale (EIS)

    Exercise Identity Scale (EIS) is a measure of how important exercise is in daily life

    Measured: immediately after the 8-week intervention

  27. Psychological Need Satisfaction in Exercise Scale (PNSE)

    Psychological Need Satisfaction in Exercise Scale (PNSE) is an exercise psychological measure consisting of detailed items of self-confidence, autonomy, and belonging related to exercise.

    Measured: Baseline

  28. Psychological Need Satisfaction in Exercise Scale (PNSE)

    Psychological Need Satisfaction in Exercise Scale (PNSE) is an exercise psychological measure consisting of detailed items of self-confidence, autonomy, and belonging related to exercise.

    Measured: immediately after the 8-week intervention

  29. Godin Leisure Time Exercise Questionnaire (GLTEQ)

    Godin Leisure Time Exercise Questionnaire (GLTEQ) is a self-report measure of the frequency of light-intensity, moderate-intensity, and vigorous-intensity leisure-time physical activity. It evaluated how satisfied the participants were with the intervention.

    Measured: Baseline

  30. Godin Leisure Time Exercise Questionnaire (GLTEQ)

    Godin Leisure Time Exercise Questionnaire (GLTEQ) is a self-report measure of the frequency of light-intensity, moderate-intensity, and vigorous-intensity leisure-time physical activity. It evaluated how satisfied the participants were with the intervention.

    Measured: immediately after the 8-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start1 May 2020
  3. Primary completion30 Sep 2020
  4. Study completion8 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05855785
Sponsor's protocol ID
20-2020-38
Status last verified
May 2023
First submitted
30 Mar 2023
Last updated
11 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25972801

Questions about this trial

What is this clinical trial studying?

A study testing dual task exercise and home exercise in people with Cognitive Dysfunction and Mild Cognitive Impairment, run by Seoul National University Boramae Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dual task cost in Timed up and go (TUG) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05855785, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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