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Not yet recruiting NCT07163039

The Effect of Dual Task Training on Cognitive in Alzheimer's Disease

No phase Interventional Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual-Task Motor-Cognitive Training, Conventional Exercise Training.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Other 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.
  • Other 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.

Primary outcome measures

  • d2 Test of Attention [Time frame: 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]
  • Stroop Test [Time frame: 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]
  • Montreal Cognitive Assessment (MoCA) [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (12)
  • Symbol Digit Modalities Test (SDMT) [Time frame: 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]
  • Disability Assessment for Dementia (DAD) [Time frame: 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]
  • Performance Measures: Walking speed [Time frame: 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]
  • Performance Measures: Number of correct response Number of correct responses [Time frame: 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]
  • Gait Analysis System: Walking speed during single-task walking [Time frame: 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]
  • Gait Analysis System:Balance during dual-task walking [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07163039 · 63.2025fbu

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗