INDIVIDUALIZED DUAL-TASK TRAINING FOR BALANCE AND MOBILITY IN OLDER ADULTS

NCT07448961 | Recruiting

• 1 other identifier: ebrrwlMU
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Older Adults; Postural Balance; Dual Task Exercises in Elderly People; Dual Task Cost

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Berg Balance Scale (BBS)

  Baseline and at the end of the 8-week intervention.

• 10-Meter Walk Test (10MWT)

  Baseline and at the end of the 8-week intervention.

• Falls Efficacy Scale-International (FES-I)

  Baseline and at the end of the 8-week intervention.

• Montreal Cognitive Assessment (MoCA)

  Baseline and at the end of the 8-week intervention.

Study Arms (3)

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.

Behavioral: Individualized Dual-Task Training

Standardized Dual-Task Group

ACTIVE COMPARATOR

Participants will receive a standard (fixed-progression) dual-task training program 3 days a week for 8 weeks.

Behavioral: Standardized Dual-Task Training

Single-Task Control Group

OTHER

Participants will perform single motor tasks (walking or balance exercises only) without simultaneous cognitive tasks for the same duration.

Behavioral: Single-Task Motor Training

Interventions

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.

Single-Task Control Group

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.

Individualized Dual-Task Group

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.

Standardized Dual-Task Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sezen Karaborklu Argut: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Faculty of Health Sciences

Istanbul, Istanbul, 34500, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 35940246 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.

  PMID: 41566097 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.

  PMID: 41152559 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.

  PMID: 38364709 RESULT

Study Officials

• Sezen Karabörklü Argut, PhD

  Istanbul University-Cerrahpasa, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sezen Karabörklü Argut, PhD

CONTACT

+902128663700; s.karaborkluargut@iuc.edu.tr

Melike N Can, PT

CONTACT

melikenur.can@ogr.iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)