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Clinical Trials/NCT06731049
NCT06731049
Not Yet Recruiting
N/A

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

Istanbul University - Cerrahpasa0 sites46 target enrollmentMarch 1, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer' Disease
Sponsor
Istanbul University - Cerrahpasa
Enrollment
46
Primary Endpoint
Timed Up and Go Test
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2025
End Date
July 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa
Responsible Party
Principal Investigator
Principal Investigator

Kübra Nur Menengiç

MSc

Istanbul University - Cerrahpasa

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

Outcomes

Primary Outcomes

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.

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.

Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Time Frame: 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 Outcomes

  • 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)
  • Dual-Task Performance(From enrollment to the end of treatment at 8 weeks)

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