Clinical trial NCT06731049: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer&#39; Disease
Dementia
Keywords: Treadmill
Dual-task
Exercise
Rehabilitation
Physiotherapy and rehabilitation
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timed Up and Go Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Trail Making Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Verbal Fluency Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Digit Span Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Four-Step Balance Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 10-Meter Walk Test
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Dual-Task Performance
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
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