Comparison of the Effectiveness of Treadmill-Based Walking and Dual-Task Walking Training in Alzheimer's Disease

NCT06731049 | Recruiting

• 1 other identifier: DT Treadmill Training in AD
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer' Disease; Dementia

Keywords

Treadmill; Dual-task; Exercise; Rehabilitation; Physiotherapy and rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

• Montreal Cognitive Assessment (MoCA)

  From enrollment to the end of treatment at 8 weeks

• Verbal Fluency Test

  From enrollment to the end of treatment at 8 weeks

• Digit Span Test

  From enrollment to the end of treatment at 8 weeks

• Four-Step Balance Test

  From enrollment to the end of treatment at 8 weeks

• 10-Meter Walk Test

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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.

Interventions

Treadmill-based Training Group OTHER

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 Group OTHER

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.

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Disease; Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Central Study Contacts

Kübra Nur Menengiç, MSc

CONTACT

+90 216 547 26 00; kmenengic@gmail.com

İpek Yeldan, Prof. Dr.

CONTACT

+90 212 866 37 00; ipekyeldan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)