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This randomized controlled clinical trial aims to evaluate the effectiveness of dual-task training on cognitive functions in patients with Alzheimer's disease. Participants will be randomly assigned to either a dual-task training group or a conventional exercise group. The intervention will last 8 weeks, with three supervised sessions per week. Cognitive performance, mobility, balance, and quality of life will be assessed before and after the intervention.
Alzheimer's disease is a progressive neurodegenerative disorder characterized by impairments in memory, executive function, and daily activities. Conventional exercise programs may improve mobility and physical performance, but their impact on cognition is limited. Dual-task training, which integrates motor and cognitive activities simultaneously, has emerged as a promising strategy to enhance neuroplasticity and functional independence in individuals with cognitive decline.
In this study, participants diagnosed with Alzheimer's disease according to standard clinical criteria will be recruited. After baseline assessments, participants will be randomly allocated to one of two groups:
Experimental Group (Dual-Task Training): Participants will perform exercises combining cognitive tasks (e.g., arithmetic, memory recall, word association) with simultaneous motor tasks (e.g., walking, balance training, functional mobility exercises).
Control Group (Conventional Exercise): Participants will engage in standard physical exercises focusing on strength, flexibility, and balance, without added cognitive tasks.
The intervention will span 8 weeks, with three 45-60 minute sessions per week, conducted under supervision by a physiotherapist.
Outcome Measures
Primary Outcomes: Cognitive performance assessed by the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).
Secondary Outcomes: Functional mobility (Timed Up and Go test), balance (Berg Balance Scale), and quality of life (QoL-AD questionnaire).
Hypothesis
It is hypothesized that dual-task training will lead to greater improvements in cognitive performance and functional independence compared to conventional exercise programs. This study may provide evidence supporting dual-task rehabilitation as a complementary approach in the management of Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-task motor-cognitive training | Experimental | Participants assigned to this group will undergo dual-task motor-cognitive training, which combines physical exercises with simultaneous cognitive tasks. Sessions will last 45-60 minutes, three times per week, for 8 weeks. Exercises will include gait and balance activities performed while engaging in cognitive tasks such as arithmetic, memory recall, or word association. |
|
| Conventional Exercise Training | Active Comparator | Participants in this group will receive a conventional exercise program focusing on strength, flexibility, and balance without a cognitive component. Sessions will last 45-60 minutes, three times per week, for 8 weeks, and will be supervised by a physiotherapist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-Task Motor-Cognitive Training | Other | Participants assigned to this group will undergo dual-task motor-cognitive training, which combines physical exercises with simultaneous cognitive tasks. Sessions will last 45-60 minutes, three times per week, for 8 weeks. Exercises will include gait and balance activities performed while engaging in cognitive tasks such as arithmetic, memory recall, or word association. |
| Measure | Description | Time Frame |
|---|---|---|
| d2 Test of Attention | A widely used neuropsychological test evaluating visual attention and processing speed. Participants are asked to quickly and accurately mark target symbols (e.g., the letter "d" with two dashes) among distractors on a sheet consisting of similar letters and symbols. | From enrollment to the end of treatment at 8 weeks |
| Trail Making Test Part A (TMT-A) | Assesses visual attention, processing speed, and psychological flexibility. The participant is required to connect numbered circles from 1 to 25 in order as quickly as possible. | From enrollment to the end of treatment at 8 weeks |
| Stroop Test | Stroop Test: Evaluates executive functions and attentional control. The participant must state the ink color of a word rather than reading the written word itself (e.g., the word "Blue" written in red ink should be answered as "red") | From enrollment to the end of treatment at 8 weeks |
| Trail Making Test Part B (TMT-B): | Trail Making Test Part B (TMT-B): Used to assess executive functions, cognitive flexibility, and attention. The participant alternates between numbers and letters in sequence (1-A-2-B-3-C…) | From enrollment to the end of treatment at 8 weeks |
| Montreal Cognitive Assessment (MoCA) | Montreal Cognitive Assessment (MoCA): Evaluates memory, attention, executive functions, and visuospatial skills. It is a standard and validated tool for monitoring cognitive status and comparing pre- and post-intervention performance in Alzheimer's patients | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symbol Digit Modalities Test (SDMT) | Symbol Digit Modalities Test (SDMT): Measures processing speed and attention. Participants are presented with a key of symbol-digit pairings and asked to match as many symbols with their corresponding digits as possible within a set time | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sümeyye AKÇAY, PhD | Contact | +90 542 400 25 53 | sumeyye.akcay@fbu.edu.tr | |
| Burcu AKKURT, PhD | Contact | 05536046713 | burcu.akkurt@fbu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Sümeyye AKÇAY, PhD | Fenerbahçe University | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2025 | Sep 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Conventional Exercise Training | Other | Participants in this group will receive a conventional exercise program focusing on strength, flexibility, and balance without a cognitive component. Sessions will last 45-60 minutes, three times per week, for 8 weeks, and will be supervised by a physiotherapist. |
|
| Functional Near-Infrared Spectroscopy (fNIRS) |
Functional Near-Infrared Spectroscopy (fNIRS): A non-invasive method to measure prefrontal cortex activation by monitoring oxygenated and deoxygenated hemoglobin levels |
| From enrollment to the end of treatment at 8 weeks |
| Disability Assessment for Dementia (DAD) | Disability Assessment for Dementia (DAD): Developed to assess independence in activities of daily living among individuals with dementia. It evaluates both basic and instrumental activities of daily living, including self-care and social functioning | From enrollment to the end of treatment at 8 weeks |
| Dual Task Protocol | Dual Task Protocol: Participants will perform physical and cognitive tasks simultaneously. For example, during walking, they will be asked to complete word generation, simple arithmetic, or other attention-demanding tasks | From enrollment to the end of treatment at 8 weeks |
| Performance Measures: Walking speed | Walking speed (measured using a metronome or gait analysis system). | From enrollment to the end of treatment at 8 weeks |
| Performance Measures: Step count | Step count (measured using a metronome or gait analysis system). | From enrollment to the end of treatment at 8 weeks |
| Performance Measures: Number of correct response Number of correct responses | Number of correct responses recorded during the secondary cognitive task. | From enrollment to the end of treatment at 8 weeks |
| Performance Measures: incorrect response | Percentage of incorrect responses recorded during the secondary cognitive task. | From enrollment to the end of treatment at 8 weeks |
| Gait Analysis System: Walking speed during single-task walking | Provides objective evaluation of walking dynamics using pressure sensors, motion capture systems, or accelerometers. | From enrollment to the end of treatment at 8 weeks |
| Gait Analysis System: Step length during single-task walking | Provides objective evaluation of walking dynamics using pressure sensors, motion capture systems, or accelerometers. | From enrollment to the end of treatment at 8 weeks |
| Gait Analysis System:Balance during dual-task walking | Provides objective evaluation of walking dynamics using pressure sensors, motion capture systems, or accelerometers. | From enrollment to the end of treatment at 8 weeks |
| Gait Analysis System: Postural control during dual-task walking | Provides objective evaluation of walking dynamics using pressure sensors, motion capture systems, or accelerometers. | From enrollment to the end of treatment at 8 weeks |
| Electromyography (EMG) | Electromyography (EMG): Measures muscle electrical activity through surface electrodes, providing data on contraction duration, activation levels, and coordination (De Luca, 1997). EMG will be used to assess changes in motor control and muscle activation during dual-task training. | From enrollment to the end of treatment at 8 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |