- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07163039
- Original Trial
The Effect of Dual Task Training on Cognitive in Alzheimer's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sümeyye AKÇAY, PhD
- Phone Number: +90 542 400 25 53
- Email: sumeyye.akcay@fbu.edu.tr
Study Contact Backup
- Name: Burcu AKKURT, PhD
- Phone Number: 05536046713
- Email: burcu.akkurt@fbu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 60 years
- Diagnosed with mild-stage Alzheimer's disease (According to DSM-5 or NINCDS-ADRDA criteria)
- MoCA score between 10-25 (Indicating sufficient cognitive capacity for dual-task training)
- Ability to walk independently or with minimal assistance
- Adequate hearing and vision to enable communication
- Physical and mental capacity to participate in the dual-task training protocol
- Provision of written informed consent (signed informed consent form)
Exclusion Criteria:
- Diagnosis of advanced-stage Alzheimer's disease (MoCA < 10)
- Presence of additional neurological disorders affecting the motor system (e.g. Parkinson's disease, stroke, multiple sclerosis)
- Severe hearing or vision impairment (inability to respond to visual or auditory stimuli)
- History of psychiatric disorders (e.g., major depression, schizophrenia)
- Orthopedic or cardiopulmonary conditions that would prevent participation in dual-task training
- Participation in another cognitive or physical rehabilitation program within the last 3 months
- Individuals with unstable cognitive status due to recent medication changes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dual-task motor-cognitive training
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.
|
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.
|
|
Active Comparator: Conventional Exercise Training
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
d2 Test of Attention
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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):
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symbol Digit Modalities Test (SDMT)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
|
|
Functional Near-Infrared Spectroscopy (fNIRS)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Walking speed (measured using a metronome or gait analysis system).
|
From enrollment to the end of treatment at 8 weeks
|
|
Performance Measures: Step count
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Number of correct responses recorded during the secondary cognitive task.
|
From enrollment to the end of treatment at 8 weeks
|
|
Performance Measures: incorrect response
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sümeyye AKÇAY, PhD, Fenerbahce University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 63.2025fbu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeWithdrawnAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.Active, not recruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
Stanford UniversityNot yet recruitingMCI With Increased Risk for Alzheimer Disease | Alzheimer s DiseaseUnited States
-
University of California, Los AngelesRecruitingAlzheimer Disease | Dementia Alzheimer Type | Alzheimer&Amp;#39;s Disease (AD) | Alzheimer&Amp;Amp;#39;s Disease | Mild Alzheimer&Amp;Amp;#39;s Disease | Moderate Alzheimer&Amp;Amp;#39;s Disease | Alzheimer&Amp;#39;s DementiaUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Heinrich-Heine University, DuesseldorfNot yet recruitingEarly Onset Alzheimer Disease | Alzheimer Disease (AD)Germany
-
Johns Hopkins UniversityNational Institutes of Health (NIH)Not yet recruiting
-
Xuanwu Hospital, BeijingEnrolling by invitation
-
ChainGen Biopharma LtdChainGen Biopharma (Australia) Pty LtdNot yet recruiting
-
University Hospital, GrenobleRecruiting
Clinical Trials on Dual-Task Motor-Cognitive Training
-
University of PlymouthRecruiting
-
Saglik Bilimleri UniversitesiEskisehir Osmangazi University; Anadolu UniversityRecruitingParkinson's Disease (PD)Turkey (Türkiye)
-
Chang Gung UniversityCompletedStroke | Healthy Older AdultsTaiwan
-
University Hospital TuebingenParkinson StiftungNot yet recruitingMild Cognitive Impairment (MCI) | PARKINSON DISEASE (Disorder)Germany
-
Istanbul University - CerrahpasaNot yet recruiting
-
Riphah International UniversityActive, not recruiting
-
Riphah International UniversityCompletedIntellectual DisabilityPakistan
-
Yu XiaoCompletedGait | Older Adults, Balance | Balance | Dual-task | Older Adults (65 Years and Older) | Quality of Life (QOL)China
-
Tan Tock Seng HospitalNational Neuroscience Institute; Nanyang PolytechnicRecruitingMild Cognitive ImpairmentSingapore
-
University of LahoreCompletedStroke | Hemiplegia | Hemiplegia Following Ischemic StrokePakistan