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NCT Number: NCT07448961

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Faculty of Health Sciences

Istanbul, 34500, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Falls Efficacy Scale-International (FES-I)

    Time frame: Baseline and at the end of the 8-week intervention.

    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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melike N Can, PT

CONTACT

[email protected]

Sezen Karabörklü Argut, PhD

CONTACT

[email protected]

+902128663700 ext. 28325

Sponsors and collaborators

Lead sponsor

Sezen Karaborklu Argut

Other

Registry information

Official study title

EFFECTS OF SENSORİAL AND COGNİTİVE INDİVİDUALİZED DUAL-TASK TRAİNİNG ON FUNCTİONAL BALANCE, MOBİLİTY, AND DUAL-TASK PERFORMANCE İN OLDER ADULTS: A RANDOMİZED CONTROLLED TRİAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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