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

Not Applicable

Not yet recruiting

• Conditions: Alzheimer' Disease; Dementia

• Registration Number: NCT06731049
• Lead Sponsor: Istanbul University - Cerrahpasa

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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Study Start: 2025-03-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Timed Up and Go Test	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	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)	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.

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	From enrollment to the end of treatment at 8 weeks	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.
Verbal Fluency Test	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.
Digit Span Test	From enrollment to the end of treatment at 8 weeks	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).
Four-Step Balance Test	From enrollment to the end of treatment at 8 weeks	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.
10-Meter Walk Test	From enrollment to the end of treatment at 8 weeks	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.
Dual-Task Performance	From enrollment to the end of treatment at 8 weeks	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.