INDIVIDUALIZED DUAL-TASK TRAINING FOR BALANCE AND MOBILITY IN OLDER ADULTS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSezen Karaborklu Argut
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized Dual-Task Training
BehavioralAn 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
BehavioralAn 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
BehavioralAn 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.
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Individualized Dual-Task GroupExperimental treatment 1 intervention
Group B: Standardized Dual-Task GroupActive comparator 1 intervention
Group C: Single-Task Control GroupOther 1 intervention
Trial outcomes
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.
Time frame
Baseline and at the end of the 8-week intervention.Secondary outcomes
1
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.
Time frame
Baseline and at the end of the 8-week intervention.2
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.
Time frame
Baseline and at the end of the 8-week intervention.3
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.
Time frame
Baseline and at the end of the 8-week intervention.4
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.
Time frame
Baseline and at the end of the 8-week intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sezen Karaborklu Argut
Lead sponsor
Istanbul University - Cerrahpasa
Sponsor institution
Source ClinicalTrials.gov