- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06731049
Comparison of the Effectiveness of Treadmill-Based Walking and Dual-Task Walking Training in Alzheimer's Disease
March 25, 2026 updated by: Kübra Nur Menengiç, Istanbul University - Cerrahpasa
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kübra Nur Menengiç, MSc
- Phone Number: 2755 +90 216 547 26 00
- Email: kmenengic@gmail.com
Study Contact Backup
- Name: İpek Yeldan, Prof. Dr.
- Phone Number: 28005 +90 212 866 37 00
- Email: ipekyeldan@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul University-Cerrahpasa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treadmill Based Training Group
In the study, for 8 weeks, the Treadmill-based Training Group will undergo walking training on a treadmill two days a week.
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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.
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Experimental: Dual-Task Treadmill Based Training Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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From enrollment to the end of treatment at 8 weeks
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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.
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From enrollment to the end of treatment at 8 weeks
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Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Time Frame: From enrollment to the end of treatment at 8 weeks
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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.
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From enrollment to the end of treatment at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Verbal Fluency Test
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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.
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From enrollment to the end of treatment at 8 weeks
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Digit Span Test
Time Frame: From enrollment to the end of treatment at 8 weeks
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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).
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From enrollment to the end of treatment at 8 weeks
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Four-Step Balance Test
Time Frame: From enrollment to the end of treatment at 8 weeks
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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.
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From enrollment to the end of treatment at 8 weeks
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10-Meter Walk Test
Time Frame: From enrollment to the end of treatment at 8 weeks
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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.
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From enrollment to the end of treatment at 8 weeks
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Dual-Task Performance
Time Frame: From enrollment to the end of treatment at 8 weeks
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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.
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From enrollment to the end of treatment at 8 weeks
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Montreal Cognitive Assessment (MoCA)
Time Frame: From enrollment to the end of treatment at 8 weeks
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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.
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From enrollment to the end of treatment at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
December 9, 2024
First Submitted That Met QC Criteria
December 9, 2024
First Posted (Actual)
December 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DT Treadmill Training in AD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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