Alzheimer' DiseaseNCT06731049
Comparison of the Effectiveness of Treadmill-Based Walking and Dual-Task Walking Training in Alzheimer's Disease
A study testing Treadmill-based Training Group and Dual-Task Treadmill-based Training Group in people with Alzheimer' Disease and Dementia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Alzheimer's disease is a neurodegenerative condition that affects both cognitive and motor functions, making daily life activities more challenging. Motor functions, especially walking and balance, begin to deteriorate early in the disease and progress in parallel with cognitive decline. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Alzheimer' Disease, Dementia
- What is being tested?
- Treadmill-based Training Group and Dual-Task Treadmill-based Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of Alzheimer's disease according to the NINCDS-ADRDA criteria by a neurologist,
- In the early or middle stages of the disease according to the Clinical Dementia Rating Scale (CDR),
- Receiving medical treatment for Alzheimer's disease (e.g., cholinesterase inhibitors or memantine) for at least the past month,
- Able to walk at least 400 meters in the 6-Minute Walk Test, indicating functional mobility,
- Able to read and understand instructions given in Turkish.
Who cannot join
- Having Lewy body dementia, frontotemporal dementia, or other types of dementia
- Participating in a structured exercise program within the 6 months prior to starting the study
- Having pulmonary, neurological, musculoskeletal, or rheumatological diseases that hinder walking
- Having an unstable medical condition (e.g., uncontrolled diabetes or hypertension, deep vein thrombosis, etc.)
- Having visual or auditory impairments that make communication difficult
- Having behavioral problems that make participation in exercise difficult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul University-Cerrahpaşa
Istanbul
About this study
Official title: Comparison of the Effects of Treadmill-Based Walking and Dual-Task Walking Training on Activity and Cognition in Alzheimer's Disease
Alzheimer's disease is a neurodegenerative condition that affects both cognitive and motor functions, making daily life activities more challenging. Motor functions, especially walking and balance, begin to deteriorate early in the disease and progress in parallel with cognitive decline. Dual-task performance, which refers to the ability to perform both motor and cognitive tasks simultaneously, significantly decreases in individuals with Alzheimer's disease. Current studies suggest that dual-task exercises can improve both cognitive and motor functions. In this context, treadmill-based dual-task training emerges as a promising approach to mitigate the effects of Alzheimer's disease. The study hypothesizes that treadmill-based dual-task training will have more positive effects on motor and cognitive parameters compared to treadmill exercise alone in individuals with Alzheimer's disease. The main research question of this study is whether treadmill-based dual-task exercise training, designed with progressively more challenging cognitive and motor tasks and tailored to the individual, results in significant improvements in motor and cognitive parameters, as well as daily living activities and dual-task performance, compared to a group that only undergoes treadmill exercise.
Read the detailed description
The aim of this project is to investigate the effects of treadmill-based dual-task exercise training, which is individually designed and progressively challenging, on functional mobility, cognitive function, walking speed, balance, and dual-task performance in Alzheimer's disease. The results obtained from this training will be compared only to those of treadmill-based walking training. The goal of this project is to enhance the level of independence in daily life by improving cognitive and physical parameters related to body structure and function. In the study, for 8 weeks, the Treadmill-based Training Group will receive walking training on the treadmill twice a week, while the Dual-Task Treadmill-based Training Group will undergo dual-task walking training, which includes both motor and cognitive tasks on the treadmill. At the beginning and end of the 8-week training period, functional mobility, cognitive function, ability to perform activities of daily living, balance, walking speed, and dual-task performance will be measured.
- Conditions
- Alzheimer' Disease, Dementia
- Being tested
- Treadmill-based Training Group, Dual-Task Treadmill-based Training Group
- Keywords
- Treadmill, Dual-task, Exercise, Rehabilitation, Physiotherapy and rehabilitation
- Medical subject headings
- Disease, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill-based Training GroupOther
The walking speed will start at 75% of the walking speed calculated from the 10-meter Walk Test at normal walking pace, and the treadmill training will begin at this speed. Every two weeks, the speed will increase by 5%, and by the end of the 8th week, it will reach 100% of the normal walking speed. The aim of gradually increasing the walking speed is to progressively make the motor component of the exercise more challenging. Throughout the 8 weeks, a body weight support system will be used, and the support from the treadmill bar will be gradually reduced.
Dual-Task Treadmill-based Training GroupOther
In the Dual-Task Treadmill-based Training Group, the same walking training protocol as the Treadmill Training Group will be applied with added second tasks to create a dual-task walking protocol. The second tasks will consist of both cognitive and motor tasks. The difficulty of the tasks and the total duration of the dual-task training will be increased over time.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Based Training Group | Active comparator | In the study, for 8 weeks, the Treadmill-based Training Group will undergo walking training on a treadmill two days a week. |
| Dual-Task Treadmill Based Training Group | Experimental | Dual-Task Treadmill-based Training Group will receive dual-task walking training involving both motor and cognitive tasks on the treadmill for 8 week, two days in a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test
Timed Up and Go Test (TUG) In the Timed Up and Go Test, the participant is instructed to stand up from a fixed chair placed on a non-slip surface with their knees and hips at approximately 90 degrees, walk 3 meters, turn around, and sit back down. The time taken to complete these activities is recorded.
Measured: From enrollment to the end of treatment at 8 weeks
Trail Making Test
The Trail Making Test, used to assess executive functions, has two versions: A and B. In version A, a page with scattered numbers is given to the participant, and they are asked to connect the numbers from 1 to 25 in sequence as quickly as possible. In version B, a page with both numbers (1-13) and letters (A-L) is provided. The participant is instructed to connect the numbers and letters in sequence, alternating between 1-A-2-B-3-C, and so on. The time taken to complete each task is recorded in seconds.
Measured: From enrollment to the end of treatment at 8 weeks
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
The ADCS-ADL, developed specifically for Alzheimer's disease, consists of 23 items-6 basic and 17 instrumental activities of daily living-that assess the participant's level of independence. Questions are directed to the caregiver, focusing on the participant's performance over the last 4 weeks. The total score ranges from 0 to 78, with lower scores indicating higher levels of dependency.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Montreal Cognitive Assessment (MoCA)
MoCA is a widely used screening test for global cognitive function. It assesses cognitive abilities in 6 domains: calculation, abstract thinking, orientation, executive function, memory, verbal fluency, attention, and visual-spatial abilities. A total score above 21 indicates normal cognitive function.
Measured: From enrollment to the end of treatment at 8 weeks
Verbal Fluency Test
The Verbal Fluency Test evaluates verbal fluency and executive functions under two categories: phonemic and semantic fluency. In the phonemic fluency section, the number of words starting with the letters K, A, and S produced by the participant is recorded. In the semantic fluency section, the total number of words related to selected categories such as animals, fruits, furniture, or vehicles is recorded. The total time for the test is 60 seconds, and the number of words produced every 15 seconds is recorded separately.
Measured: From enrollment to the end of treatment at 8 weeks
Digit Span Test
This test is used to assess short-term memory and attention. In the forward digit span section, the participant is asked to repeat the numbers read aloud by the examiner in the same order, while in the backward digit span section, they must repeat the numbers in reverse order. The test begins with a span of 3 numbers, and after correctly repeating the given sequence, the length of the number sequence is increased one digit at a time (e.g., 3-7, 1-5-9, 4-8-2-7, 6-3-1-9-2).
Measured: From enrollment to the end of treatment at 8 weeks
Four-Step Balance Test
This test is used to measure static balance. The participant is asked to stand for 10 seconds in four different positions on a firm and stable surface: with both feet together, semi-tandem, tandem, and one foot.
Measured: From enrollment to the end of treatment at 8 weeks
10-Meter Walk Test
The 10-Meter Walk Test is a performance-based test used to evaluate walking speed. A 14-meter distance is measured, with an additional 2 meters at the start and end of the walking path. The time taken to walk the 10-meter distance is recorded in seconds.
Measured: From enrollment to the end of treatment at 8 weeks
Dual-Task Performance
Dual-task performance will be assessed by applying the Timed Up and Go Test along with cognitive tasks such as naming animals, generating words starting with the same letter, and repeating given sequences of numbers in order.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Aug 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer' DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Nur Menengiç, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731049
- Sponsor's protocol ID
- DT Treadmill Training in AD
- Status last verified
- Mar 2026
- First submitted
- 9 Dec 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Treadmill-Based Walking and Dual-Task Walking Training on Activity and Cognition in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06731049
- Acronym / sponsor ID
- DT Treadmill Training in AD
- Conditions
- Alzheimer' Disease, Dementia
- Keywords
- Treadmill, Dual-task, Exercise, Rehabilitation, Physiotherapy and rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Dec 2024 (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.
Alzheimer's disease is a neurodegenerative condition that affects both cognitive and motor functions, making daily life activities more challenging. Motor functions, especially walking and balance, begin to deteriorate early in the disease and progress in parallel with cognitive decline. Dual-task performance, which refers to the ability to perform both motor and cognitive tasks simultaneously, significantly decreases in individuals with Alzheimer's disease. Current studies suggest that dual-task exercises can improve both cognitive and motor functions. In this context, treadmill-based dual-task training emerges as a promising approach to mitigate the effects of Alzheimer's disease. The study hypothesizes that treadmill-based dual-task training will have more positive effects on motor and cognitive parameters compared to treadmill exercise alone in individuals with Alzheimer's disease. The main research question of this study is whether treadmill-based dual-task exercise training, designed with progressively more challenging cognitive and motor tasks and tailored to the individual, results in significant improvements in motor and cognitive parameters, as well as daily living activities and dual-task performance, compared to a group that only undergoes treadmill exercise.
Detailed description
The aim of this project is to investigate the effects of treadmill-based dual-task exercise training, which is individually designed and progressively challenging, on functional mobility, cognitive function, walking speed, balance, and dual-task performance in Alzheimer's disease. The results obtained from this training will be compared only to those of treadmill-based walking training. The goal of this project is to enhance the level of independence in daily life by improving cognitive and physical parameters related to body structure and function. In the study, for 8 weeks, the Treadmill-based Training Group will receive walking training on the treadmill twice a week, while the Dual-Task Treadmill-based Training Group will undergo dual-task walking training, which includes both motor and cognitive tasks on the treadmill. At the beginning and end of the 8-week training period, functional mobility, cognitive function, ability to perform activities of daily living, balance, walking speed, and dual-task performance will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill Based Training Group | Active comparator | –In the study, for 8 weeks, the Treadmill-based Training Group will undergo walking training on a treadmill two days a week. |
| Dual-Task Treadmill Based Training Group | Experimental | –Dual-Task Treadmill-based Training Group will receive dual-task walking training involving both motor and cognitive tasks on the treadmill for 8 week, two days in a week. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Alzheimer's disease according to the NINCDS-ADRDA criteria by a neurologist,
- In the early or middle stages of the disease according to the Clinical Dementia Rating Scale (CDR),
- Receiving medical treatment for Alzheimer's disease (e.g., cholinesterase inhibitors or memantine) for at least the past month,
- Able to walk at least 400 meters in the 6-Minute Walk Test, indicating functional mobility,
- Able to read and understand instructions given in Turkish.
Key exclusion criteria (6 listed)
- Having Lewy body dementia, frontotemporal dementia, or other types of dementia
- Participating in a structured exercise program within the 6 months prior to starting the study
- Having pulmonary, neurological, musculoskeletal, or rheumatological diseases that hinder walking
- Having an unstable medical condition (e.g., uncontrolled diabetes or hypertension, deep vein thrombosis, etc.)
- Having visual or auditory impairments that make communication difficult
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 |
|---|---|---|
| Treadmill-based Training GroupThe walking speed will start at 75% of the walking speed calculated from the 10-meter Walk Test at normal walking pace, and the treadmill training will begin at this speed. Every two weeks, the speed will increase by 5%, and by the end of the 8th week, it will reach 100% of the normal walking speed. The aim of gradually increasing the walking speed is to progressively make the motor component of the exercise more challenging. Throughout the 8 weeks, a body weight support system will be used, and the support from the treadmill bar will be gradually reduced. | Other | – |
| Dual-Task Treadmill-based Training GroupIn the Dual-Task Treadmill-based Training Group, the same walking training protocol as the Treadmill Training Group will be applied with added second tasks to create a dual-task walking protocol. The second tasks will consist of both cognitive and motor tasks. The difficulty of the tasks and the total duration of the dual-task training will be increased over time. | Other | – |
Primary outcome
Timed Up and Go Test
Time frame: From enrollment to the end of treatment at 8 weeks
Timed Up and Go Test (TUG) In the Timed Up and Go Test, the participant is instructed to stand up from a fixed chair placed on a non-slip surface with their knees and hips at approximately 90 degrees, walk 3 meters, turn around, and sit back down. The time taken to complete these activities is recorded.
Trail Making Test
Time frame: From enrollment to the end of treatment at 8 weeks
The Trail Making Test, used to assess executive functions, has two versions: A and B. In version A, a page with scattered numbers is given to the participant, and they are asked to connect the numbers from 1 to 25 in sequence as quickly as possible. In version B, a page with both numbers (1-13) and letters (A-L) is provided. The participant is instructed to connect the numbers and letters in sequence, alternating between 1-A-2-B-3-C, and so on. The time taken to complete each task is recorded in seconds.
Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Time frame: From enrollment to the end of treatment at 8 weeks
The ADCS-ADL, developed specifically for Alzheimer's disease, consists of 23 items-6 basic and 17 instrumental activities of daily living-that assess the participant's level of independence. Questions are directed to the caregiver, focusing on the participant's performance over the last 4 weeks. The total score ranges from 0 to 78, with lower scores indicating higher levels of dependency.
6 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: From enrollment to the end of treatment at 8 weeks
Verbal Fluency Test
Time frame: From enrollment to the end of treatment at 8 weeks
Digit Span Test
Time frame: From enrollment to the end of treatment at 8 weeks
Four-Step Balance Test
Time frame: From enrollment to the end of treatment at 8 weeks
10-Meter Walk Test
Time frame: From enrollment to the end of treatment at 8 weeks
Dual-Task Performance
Time frame: From enrollment to the end of treatment at 8 weeks
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 31 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill-based Training Group and Dual-Task Treadmill-based Training Group in people with Alzheimer' Disease and Dementia, run by Istanbul University - Cerrahpasa 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 5 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 31 Mar 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 Kübra Nur Menengiç, MSc (+90 216 547 26 00 ext. 2755, kmenengic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.