- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448961
INDIVIDUALIZED DUAL-TASK TRAINING FOR BALANCE AND MOBILITY IN OLDER ADULTS
EFFECTS OF SENSORİAL AND COGNİTİVE INDİVİDUALİZED DUAL-TASK TRAİNİNG ON FUNCTİONAL BALANCE, MOBİLİTY, AND DUAL-TASK PERFORMANCE İN OLDER ADULTS: A RANDOMİZED CONTROLLED TRİAL
The goal of this clinical trial is to prevent functional decline and improve mobility in healthy older adults aged 65 and over. The main questions it aims to answer are:
What is the effect of individualized dual-task training on functional balance and mobility compared to standard training? Does personalized sensory and cognitive training significantly reduce the dual-task cost during walking tasks? Researchers will compare the Individualized Dual-Task Group to a Standardized Dual-Task Group and a Single-Task Control Group to see if personalized adjustments in sensory and cognitive loads lead to superior improvements in balance, gait speed, and motor-cognitive interference.
Participants will:
Complete an initial assessment of motor and cognitive capacities to determine individual baseline levels.
Participate in a supervised exercise program 3 days a week for 8 weeks, with each session lasting 40-45 minutes.
Perform motor tasks such as walking, obstacle crossing, and balance exercises while simultaneously engaging in cognitive tasks (e.g., counting, verbal fluency).
(For the individualized group) Undergo weekly adjustments in exercise difficulty, including sensory manipulations like surface changes and head movements based on their performance.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sezen Karabörklü Argut, PhD
- Phone Number: 28325 +902128663700
- Email: s.karaborkluargut@iuc.edu.tr
Study Contact Backup
- Name: Melike N Can, PT
- Email: melikenur.can@ogr.iuc.edu.tr
Study Locations
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34500
- Recruiting
- Istanbul University-Cerrahpasa, Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 years and older.
- Living independently in the community.
- Ability to walk at least 10 meters without the use of an assistive device (e.g., cane, walker).
- Cognitively intact, defined as a Montreal Cognitive Assessment (MoCA) score of 24 or higher.
- Stable medical condition allowing for participation in an 8-week exercise program.
- Willingness to participate in the study and provide written informed consent.
Exclusion Criteria:
- History of neurological disorders affecting movement or cognition (e.g., Stroke, Parkinson's Disease, Dementia).
- Acute or chronic orthopedic conditions that severely limit gait or balance (e.g., recent lower limb fracture or major joint replacement within the last 6 months).
- Severe visual or hearing impairment that prevents following instructions or performing tasks.
- Uncontrolled cardiovascular or pulmonary disease.
- Currently participating in another structured exercise or dual-task training program.
- Inability to commit to the 8-week training schedule.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individualized Dual-Task Group
Participants will receive individualized cognitive-motor dual-task training 3 days a week for 8 weeks.
Exercises are adjusted weekly based on individual performance levels.
|
An 8-week, supervised exercise program (3 sessions/week, 40-45 min).
Training involves simultaneous motor (walking, balance, obstacle crossing) and cognitive tasks (counting, verbal fluency).
The cognitive and sensory loads are adjusted weekly based on the participant's performance (Borg Scale and task accuracy) to maintain an optimal challenge level.
|
|
Active Comparator: Standardized Dual-Task Group
Participants will receive a standard (fixed-progression) dual-task training program 3 days a week for 8 weeks.
|
An 8-week, supervised dual-task exercise program (3 sessions/week, 40-45 min).
Participants perform the same motor and cognitive tasks as the individualized group, but the progression of difficulty is fixed and follows a pre-determined schedule regardless of individual performance changes.
|
|
Other: Single-Task Control Group
Participants will perform single motor tasks (walking or balance exercises only) without simultaneous cognitive tasks for the same duration.
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An 8-week program (3 sessions/week, 40-45 min) consisting only of motor exercises such as walking and balance tasks.
No simultaneous cognitive tasks or sensory manipulations are provided during the training sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dual-Task Cost (DTC) of Functional Mobility
Time Frame: Baseline and at the end of the 8-week intervention.
|
Dual-Task Cost (DTC) will be calculated based on the Timed Up and Go (TUG) test performance.
DTC represents the percentage change in TUG time during a cognitive-motor dual-task condition (e.g., walking while counting backwards) compared to a single-task condition (walking only).
The formula is: DTC = [(Dual-Task Time - Single-Task Time) / Single-Task Time] X 100.
A higher percentage indicates greater interference and poorer dual-task performance.
|
Baseline and at the end of the 8-week intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale (BBS)
Time Frame: Baseline and at the end of the 8-week intervention.
|
A 14-item objective measure used to assess static balance and fall risk in adult populations.
Each item is scored on a 5-point scale ranging from 0 to 4. Total scores range from 0 to 56, where higher scores indicate better balance and functional mobility.
|
Baseline and at the end of the 8-week intervention.
|
|
10-Meter Walk Test (10MWT)
Time Frame: Baseline and at the end of the 8-week intervention.
|
Used to assess walking speed in meters per second (m/s) over a 10-meter distance.
Faster times (higher m/s) indicate better functional mobility and gait performance.
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Baseline and at the end of the 8-week intervention.
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Falls Efficacy Scale-International (FES-I)
Time Frame: Baseline and at the end of the 8-week intervention.
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A 16-item self-report questionnaire used to assess the level of concern about falling during social and physical activities.
Scores range from 16 to 64.
Higher scores indicate a greater fear of falling.
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Baseline and at the end of the 8-week intervention.
|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline and at the end of the 8-week intervention.
|
A brief screening tool used to assess general cognitive functions, including executive functions, memory, and attention.
Total scores range from 0 to 30.
Higher scores indicate better cognitive function.
|
Baseline and at the end of the 8-week intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sezen Karabörklü Argut, PhD, Istanbul University-Cerrahpasa, Faculty of Health Sciences
Publications and helpful links
General Publications
- Pike A, McGuckian TB, Steenbergen B, Cole MH, Wilson PH. How Reliable and Valid are Dual-Task Cost Metrics? A Meta-analysis of Locomotor-Cognitive Dual-Task Paradigms. Arch Phys Med Rehabil. 2023 Feb;104(2):302-314. doi: 10.1016/j.apmr.2022.07.014. Epub 2022 Aug 6.
- Khan MJ, Fong KNK, Wong TW, Tsang WW, Chen C, Chan WC, Winser SJ. Effectiveness of dual-task exercise in improving balance and preventing falls among older adults: systematic review with meta-analysis and meta-regression. Eur Geriatr Med. 2025 Dec;16(6):2047-2083. doi: 10.1007/s41999-025-01328-3. Epub 2025 Oct 28.
- Ercan Yildiz S, Fidan O, Gulsen C, Colak E, Genc GA. Effect of dual-task training on balance in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2024 Jun;121:105368. doi: 10.1016/j.archger.2024.105368. Epub 2024 Feb 9.
- Zhang W, Zhang W, Zu G, Yao M, Li J, Jin Y, Wang L, Tang J. Effects of task-oriented training on balance, gait, and fall in older adults: A systematic review and meta-analysis of randomized controlled trials. Aging Clin Exp Res. 2026 Jan 21;38(1):56. doi: 10.1007/s40520-025-03303-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ebrrwlMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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