- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238218
Exploring the Effectiveness of Incorporated Versus Additional Dual-Task Training Program in Community Older Adults
November 18, 2025 updated by: Ching-yi Wu
This study compared the effects of IDT and ADT on cognitive function, physical performance, instrumental activities of daily living (IADL), and quality of life in community-dwelling older adults.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
164
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guishan Dist
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Taoyuan, Guishan Dist, Taiwan, 333
- Chang Gung Memotial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age ≥ 60 years
- Able to follow instructions (Mini-Mental State Examination score ≥ 20)
- Montreal Cognitive Assessment (MoCA) score > 20
- No difficulty performing basic activities of daily living
- No diagnosis of dementia confirmed by a neurologist
Exclusion Criteria:
- Self-reported diagnosis of neurological disorders
- Unstable medical conditions (e.g., recent myocardial infarction, heart failure, recent heart surgery, or severe asthma)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The motor training component
The motor training component included stretching, aerobic exercise, strength training, and balance exercises.
Exercise intensity was gradually increased to a moderate level (50-70% of participants' maximum heart rate) using low-impact modalities to minimize injury risk and was adjusted according to individual physical condition throughout the intervention.
Warm-up and cool-down periods involved whole-body muscle stretching.
Aerobic exercises consisted of walking, marching in place, high knee lifts, kicking motions, leg curls, touchdown steps, and box steps, combining upper and lower limb movements to produce rhythmic and repetitive patterns.
Strength training comprised squats, lunges, chair sit-to-stands, weightlifting using water-filled bottles, farmer's walks, and elastic band exercises targeting both upper and lower limbs.
Balance exercises included single-leg stands, heel-to-toe walking, ball kicking, and cross-stepping.
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the cognitive task was performed concurrently but independently from the motor task, functioning as a distractor rather than a necessary prerequisite for task completion.
Examples included performing lower limb strength exercises while solving arithmetic problems or reciting memorized items while stepping.
the cognitive task was integrated within the motor task and was essential for successful completion of the combined motor-cognitive activity.
Examples included memorizing and executing movement sequences akin to dancing or completing ladder stepping patterns in a predetermined order.
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Experimental: The cognitive training
The cognitive training targeted domains such as attention, language, memory, calculation, and processing speed.
Each session incorporated one or more cognitive domains.
Attention tasks involved responding to visual or auditory cues, spotting differences in quantity, size, color, direction, or shape, and identifying specific objects within cluttered environments.
Language tasks included naming fruits, animals, and vegetables, playing word solitaire, engaging in word association, constructing sentences, spelling, reading, and picture-based storytelling.
Calculation tasks required solving arithmetic problems or calculating shopping list costs.
Processing speed activities involved timely responses to questions, such as number comparisons.
Memory tasks focused on recalling numbers, symbols, words, or daily items after presentation, as well as remembering spatial locations, shopping lists, or informational content from brochures and images.
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the cognitive task was performed concurrently but independently from the motor task, functioning as a distractor rather than a necessary prerequisite for task completion.
Examples included performing lower limb strength exercises while solving arithmetic problems or reciting memorized items while stepping.
the cognitive task was integrated within the motor task and was essential for successful completion of the combined motor-cognitive activity.
Examples included memorizing and executing movement sequences akin to dancing or completing ladder stepping patterns in a predetermined order.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change scores of Montreal Cognitive Assessment
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions.
It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions.
The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke.
Minimum: 0 (worst performance) Maximum: 30 (best performance) The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Change scores of Word List (WL) subtest from the Chinese version of the Wechsler Memory Scale-Third Edition (WMS-III)
Time Frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
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The Word List (WL) subtest from the Chinese version of the Wechsler Memory Scale-Third Edition (WMS-III) is a standardized and reliable measure of working memory .
This study utilized WL Part I (WL-I), where participants are verbally presented with a list of 12 unrelated words over four trials and asked to recall the words immediately after each trial.
Raw scores represent the total number of correct recalls across trials and are converted into age-adjusted scaled scores.
Higher scores reflect better memory performance.
The WL-WMS has demonstrated strong internal consistency (Cronbach's alpha > 0.80) and high construct validity across diverse populations .
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Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
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Change scores of Stroop Color and Word Test (SCWT)
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The Stroop Color and Word Test (SCWT) was used to examine inhibitory control .
The primary measure used was the time difference (in seconds) between the congruent and incongruent conditions.
Smaller differences indicate better inhibitory control.
The Stroop test has shown high test-retest reliability (ranging between 0.70 and 0.91) and convergent validity with other executive function measures .
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Change scores of Digit Symbol Substitution Test (DSST)
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The Digit Symbol Substitution Test (DSST), a subtest of Wechsler Adult Intelligence Scale(WAIS), was used to assess information processing speed.
It is sensitive to detect cognitive impairment and changes in cognitive function .
Participants are required to match symbols to corresponding numbers and copy the symbols into designated spaces within 120 seconds.
The DSST score is the total number of correct symbols, with higher scores indicating better information processing speed.
The DSST demonstrates excellent test-retest reliability (r = 0.89) and good concurrent validity with other cognitive processing measures .
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Change scores of Timed Up and Go (TUG)
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The TUG is a widely used screening tool to assess mobility and balance in community-dwelling older adults and to identify individuals at risk of falling ).
Faster completion times indicate better functional mobility.
The TUG demonstrates excellent inter-rater and test-retest reliability (ICC > 0.90) and good predictive validity regarding fall risk .
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Change scores of Community Integration Questionnaire (CIQ)
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The Community Integration Questionnaire (CIQ) assesses individuals' integration into social networks and engagement in productive activities such as employment, education, or volunteer work .
Higher scores indicate great level of social integration.
It has shown good internal consistency (Cronbach's alpha approximately 0.70-0.80)
and acceptable construct validity .
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Change scores of Lawton Instrumental Activities of Daily Living(L-IADL)
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The Lawton IADL Scale is a valid tool designed to evaluate the ability to perform tasks and detect early functional decline.
It is a reliable and valid tool commonly used for evaluating older adults with cognitive impairment .
The scale measures tasks such as using a telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and financial management.
Higher scores indicate greater independence in IADLs.
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Change scores of Box and Block Test (BBT)
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The Box and Block Test (BBT) assesses gross manual dexterity .
Participants move wooden blocks from one box compartment to another within 60 seconds.
The number of blocks that are moved from one compartment to another compartment is recorded.
The more blocks means the better gross manual dexterity.
The BBT shows excellent test-retest reliability (ICC = 0.95) and strong validity for manual dexterity evaluation in older adults and clinical populations .
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Change scores of Serial Sevens Test (SST)
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The Serial Sevens Test (SST) evaluates working memory via serial subtraction by sevens .
Correct and incorrect responses to SST are recorded, and the corrected number which is the difference between correct and incorrect responses is calculated.
The more corrected numbers means the better working memory.
While specific reliability data is limited, SST performance correlates moderately to strongly with other working memory and attention tasks, suggesting acceptable construct validity .
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Change scores of Frequency Discrimination (FD)
Time Frame: Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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The frequency discrimination (FD) assesses sustained attention by requiring participants to distinguish between high and low auditory pitches.
Participants discriminated between high (1000 Hz) and low (500 Hz) pitches and reported their answers in 18 trials conducted in 60 seconds.
There was a total of 18 trials conducted in 60 s.
Specifically, there were nine trials each for high- and low-pitch sounds, presented in random order with intervals of 1 to 4 seconds.
Correct and incorrect responses to FD are recorded, and the corrected number which is the difference between correct and incorrect responses is calculated.
Higher scores indicate better sustained attention.
The task shows acceptable test-retest reliability and construct validity within auditory attention paradigms .
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Baseline, posttest(after completing the intervention,often baseline after 4 week) , Midterm(2 week after completing intervention) , 3 -month after completing intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ching-yi Wu, ScD, Chang Gung Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
July 31, 2024
Study Completion (Actual)
July 31, 2024
Study Registration Dates
First Submitted
September 9, 2025
First Submitted That Met QC Criteria
November 18, 2025
First Posted (Actual)
November 20, 2025
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 18, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 109-036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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