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

NCT ID: NCT06731049

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-07-01

Brief Summary

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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

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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

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Alzheimer' Disease Dementia

Keywords

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Treadmill Dual-task Exercise Rehabilitation Physiotherapy and rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Treadmill-based Training Group

Intervention Type 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

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.

Group Type EXPERIMENTAL

Dual-Task Treadmill-based Training Group

Intervention Type 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.

Interventions

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Treadmill-based Training Group

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.

Intervention Type OTHER

Dual-Task Treadmill-based Training Group

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Alzheimer's disease according to the NINCDS-ADRDA criteria by a neurologist,
2. In the early or middle stages of the disease according to the Clinical Dementia Rating Scale (CDR),
3. Receiving medical treatment for Alzheimer's disease (e.g., cholinesterase inhibitors or memantine) for at least the past month,
4. Able to walk at least 400 meters in the 6-Minute Walk Test, indicating functional mobility,
5. Able to read and understand instructions given in Turkish.

Exclusion Criteria

1. Having Lewy body dementia, frontotemporal dementia, or other types of dementia
2. Participating in a structured exercise program within the 6 months prior to starting the study
3. Having pulmonary, neurological, musculoskeletal, or rheumatological diseases that hinder walking
4. Having an unstable medical condition (e.g., uncontrolled diabetes or hypertension, deep vein thrombosis, etc.)
5. Having visual or auditory impairments that make communication difficult
6. Having behavioral problems that make participation in exercise difficult
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Kübra Nur Menengiç

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Kübra Nur Menengiç, MSc

Role: CONTACT

Phone: +90 216 547 26 00

Email: [email protected]

İpek Yeldan, Prof. Dr.

Role: CONTACT

Phone: +90 212 866 37 00

Email: [email protected]

Other Identifiers

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DT Treadmill Training in AD

Identifier Type: -

Identifier Source: org_study_id