- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855785
Effect of Dual Task Exercise on Cognitive and Physical Function in the Elderly With Mild Cognitive Impairment
Effect of Dual-task Exercise on Cognitive and Physical Function in the Elderly With Mild Cognitive Impairment: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 07061
- Seoul National University Boramae Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- uncontrolled or unstable cardiovascular disease
- malignancy affecting general condition
- musculoskeletal problems affecting motor performance
- speech and hearing impairment
- other organic brain diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The exercise 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.
The exercise group also performed moderate-intensity home aerobic exercises for at least 60 minutes per week.
|
8-week, 3 times a week, 60-minute group exercise sessions, which were comprised of moderate-to-high intensity exercise and simultaneous cognitive tasks
|
|
Other: The control group
The control group performed 60-minute light intensity home exercise, 4 times a week for 8 weeks.
|
60-minute light intensity home exercise, 4 times a week for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dual task cost in Timed up and go (TUG)
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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)
Time Frame: immediately after the 8-week intervention
|
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
Time Frame: immediately after the 8-week intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Korean Montreal Cognitive Assessment (MoCA-K)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Korean Montreal Cognitive Assessment (MoCA-K)
Time Frame: immediately after the 8-week intervention
|
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.
|
immediately after the 8-week intervention
|
|
Korean Mini Mental Status Examination (K-MMSE)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Korean Mini Mental Status Examination (K-MMSE)
Time Frame: immediately after the 8-week intervention
|
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.
|
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)
Time Frame: Baseline
|
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.
|
Baseline
|
|
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)
Time Frame: immediately after the 8-week intervention
|
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.
|
immediately after the 8-week intervention
|
|
Short Physical Performance Battery (SPPB)
Time Frame: Baseline
|
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).
|
Baseline
|
|
Short Physical Performance Battery (SPPB)
Time Frame: immediately after the 8-week intervention
|
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).
|
immediately after the 8-week intervention
|
|
Berg Balance Scale (BBS)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Berg Balance Scale (BBS)
Time Frame: immediately after the 8-week intervention
|
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.
|
immediately after the 8-week intervention
|
|
Falls Efficacy Scale (FES)
Time Frame: Baseline
|
FES is a questionnaire that evaluates the confidence to perform the activities without falling from the 10 activities.
Higher score means good function.
|
Baseline
|
|
Falls Efficacy Scale (FES)
Time Frame: immediately after the 8-week intervention
|
FES is a questionnaire that evaluates the confidence to perform the activities without falling from the 10 activities.
Higher score means good function.
|
immediately after the 8-week intervention
|
|
Activities-specific Balance Confidence (ABC)
Time Frame: Baseline
|
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%.
|
Baseline
|
|
Activities-specific Balance Confidence (ABC)
Time Frame: immediately after the 8-week intervention
|
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%.
|
immediately after the 8-week intervention
|
|
Grip strength
Time Frame: Baseline
|
Grip strength was measured by hand dynamometer for evaluating muscle strength.
It is measured using pound(lb).
|
Baseline
|
|
Grip strength
Time Frame: immediately after the 8-week intervention
|
Grip strength was measured by hand dynamometer for evaluating muscle strength.
It is measured using pound(lb).
|
immediately after the 8-week intervention
|
|
Korean version of Physical Activity Scale for the Elderly (K-PASE)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Korean version of Physical Activity Scale for the Elderly (K-PASE)
Time Frame: during intervention(8 weeks)
|
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.
|
during intervention(8 weeks)
|
|
International Physical Activity Questionnaires Short form (IPAQ)
Time Frame: Baseline
|
IPAQ Short form consists of 7 surveys and evaluate the degree of physical activity and the time spent on physical activity for one week.
|
Baseline
|
|
International Physical Activity Questionnaires Short form (IPAQ)
Time Frame: during intervention (8 weeks)
|
IPAQ Short form consists of 7 surveys and evaluate the degree of physical activity and the time spent on physical activity for one week.
|
during intervention (8 weeks)
|
|
Metabolic Equivalent Task (MET) minutes per week
Time Frame: Baseline
|
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.
|
Baseline
|
|
Metabolic Equivalent Task (MET) minutes per week
Time Frame: during intervention(8 weeks)
|
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.
|
during intervention(8 weeks)
|
|
Bioelectrical Impedance Analysis
Time Frame: Baseline
|
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.
|
Baseline
|
|
Bioelectrical Impedance Analysis
Time Frame: immediately after the 8-week intervention
|
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.
|
immediately after the 8-week intervention
|
|
Exercise Identity Scale (EIS)
Time Frame: Baseline
|
Exercise Identity Scale (EIS) is a measure of how important exercise is in daily life
|
Baseline
|
|
Exercise Identity Scale (EIS)
Time Frame: immediately after the 8-week intervention
|
Exercise Identity Scale (EIS) is a measure of how important exercise is in daily life
|
immediately after the 8-week intervention
|
|
Psychological Need Satisfaction in Exercise Scale (PNSE)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Psychological Need Satisfaction in Exercise Scale (PNSE)
Time Frame: immediately after the 8-week intervention
|
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.
|
immediately after the 8-week intervention
|
|
Godin Leisure Time Exercise Questionnaire (GLTEQ)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Godin Leisure Time Exercise Questionnaire (GLTEQ)
Time Frame: immediately after the 8-week intervention
|
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.
|
immediately after the 8-week intervention
|
Collaborators and Investigators
Investigators
- Study Chair: Se Hee Jung, MD, PhD, Department of Rehabilitation Medicine, Seoul National University Boramae Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2020-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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