Healthy Older AdultsNCT07448961
INDIVIDUALIZED DUAL-TASK TRAINING FOR BALANCE AND MOBILITY IN OLDER ADULTS
A study testing Individualized Dual-Task Training, Standardized Dual-Task Training and Single-Task Motor Training in people with Healthy Older Adults and Postural Balance, run by Sezen Karaborklu Argut at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults, Postural Balance, Dual Task Exercises in Elderly People
- What is being tested?
- Individualized Dual-Task Training, Standardized Dual-Task Training and Single-Task Motor Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melike N Can, PT contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa, Faculty of Health Sciences
Istanbul, Istanbul, 34500
About this study
Official 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
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.
Read more
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
- Being tested
- Individualized Dual-Task Training, Standardized Dual-Task Training, Single-Task Motor Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Dual-Task TrainingBehavioural
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 TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Single-Task Motor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at the end of the 8-week intervention.
Secondary outcomes (4)
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.
Measured: Baseline and at the end of the 8-week intervention.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and at the end of the 8-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start29 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sezen Karaborklu Argut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sezen Karaborklu Argut, Istanbul University - Cerrahpasa
- Investigators
- Sezen Karabörklü Argut, PhD, Principal investigator, Istanbul University-Cerrahpasa, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448961
- Sponsor's protocol ID
- ebrrwlMU
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 35940246Zhang 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.
PubMed 41566097Khan 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.
PubMed 41152559Ercan 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.
PubMed 38364709
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07448961
- Acronym / sponsor ID
- ebrrwlMU
- Conditions
- Healthy Older Adults, Postural Balance, Dual Task Exercises in Elderly People, Dual Task Cost
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sezen Karaborklu ArgutUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individualized Dual-Task Group | Experimental | Behavioral: Individualized Dual-Task TrainingParticipants 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 | Behavioral: Standardized Dual-Task TrainingParticipants will receive a standard (fixed-progression) dual-task training program 3 days a week for 8 weeks. |
| Single-Task Control Group | Other | Behavioral: Single-Task Motor TrainingParticipants will perform single motor tasks (walking or balance exercises only) without simultaneous cognitive tasks for the same duration. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Dual-Task TrainingAn 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. | Behavioural | Individualized Dual-Task Group |
| Standardized Dual-Task TrainingAn 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. | Behavioural | Standardized Dual-Task Group |
| Single-Task Motor TrainingAn 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. | Behavioural | Single-Task Control Group |
Primary outcome
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.
4 secondary outcomes
Berg Balance Scale (BBS)
Time frame: 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.
Falls Efficacy Scale-International (FES-I)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 35940246Pike 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.
- Results publication: PubMed 41566097Zhang 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.
- Results publication: PubMed 41152559Khan 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.
- Results publication: PubMed 38364709Ercan 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melike N Can, PT contact
Sezen Karabörklü Argut, PhD principal investigator
Istanbul University-Cerrahpasa, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Dual-Task Training, Standardized Dual-Task Training and Single-Task Motor Training in people with Healthy Older Adults and Postural Balance, run by Sezen Karaborklu Argut at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sezen Karabörklü Argut, PhD (+902128663700 ext. 28325, s.karaborkluargut@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-Task Cost (DTC) of Functional Mobility (time frame: Baseline and at the end of the 8-week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07448961, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.