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

Official title

Comparison of the Effects of Treadmill-Based Walking and Dual-Task Walking Training on Activity and Cognition in Alzheimer's Disease

Overview

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.

Interventions

• Other 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
• 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.

Primary outcome measures

• Timed Up and Go Test [Time frame: From enrollment to the end of treatment at 8 weeks]
• Trail Making Test [Time frame: From enrollment to the end of treatment at 8 weeks]
• Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) [Time frame: From enrollment to the end of treatment at 8 weeks]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• İstanbul University-Cerrahpaşa — Istanbul

Identifiers

NCT: NCT06731049 · DT Treadmill Training in AD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗