Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Dual-Task Group | Experimental | 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. |
|
| Standardized Dual-Task Group | Active Comparator | Participants will receive a standard (fixed-progression) dual-task training program 3 days a week for 8 weeks. |
|
| Single-Task Control Group | Other | Participants will perform single motor tasks (walking or balance exercises only) without simultaneous cognitive tasks for the same duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Dual-Task Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dual-Task Cost (DTC) of Functional Mobility | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale (BBS) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sezen Karabörklü Argut, PhD | Contact | +902128663700 | 28325 | s.karaborkluargut@iuc.edu.tr |
| Melike N Can, PT | Contact | melikenur.can@ogr.iuc.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Sezen Karabörklü Argut, PhD | Istanbul University-Cerrahpasa, Faculty of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa, Faculty of Health Sciences | Recruiting | Istanbul | Istanbul | 34500 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35940246 | Result | 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. | |
| 41566097 | Result | 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. |
Not provided
Not provided
Individual participant data (IPD) will not be made available to other researchers at this time to protect participant privacy and maintain data confidentiality according to the initial ethical approval.
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized, single-blind, parallel-group clinical trial. Participants are randomly assigned to one of three groups (individualized dual-task training, standardized dual-task training, or single-task control) in a 1:1:1 ratio. The primary objective is to compare the effects of individualized versus standardized protocols over an 8-week intervention period.
Not provided
Not provided
The study is a single-blind trial. While participants and the physical therapist providing the intervention cannot be blinded to the group assignments due to the nature of the exercises, the outcome assessor who performs all baseline and post-intervention measurements will be kept blinded to the group allocations. Data analysis will also be conducted by a researcher blinded to the group codes.
|
| Standardized Dual-Task Training | Behavioral | 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. |
|
| Single-Task Motor Training | Behavioral | 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. |
|
| 10-Meter Walk Test (10MWT) |
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. |
| Baseline and at the end of the 8-week intervention. |
| Falls Efficacy Scale-International (FES-I) | 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. | Baseline and at the end of the 8-week intervention. |
| Montreal Cognitive Assessment (MoCA) | 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. |
| 41152559 | Result | 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. |
| 38364709 | Result | 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. |