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

NCT ID: NCT07163039

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-05-31

Brief Summary

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dual-Task Motor-Cognitive Training

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional Exercise Training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fenerbahce University

OTHER

Sponsor Role: lead

Responsible Party

Burcu AKKURT

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sümeyye AKÇAY, PhD

Role: PRINCIPAL_INVESTIGATOR

Fenerbahçe University

Central Contacts

Sümeyye AKÇAY, PhD

Role: CONTACT

sumeyye.akcay@fbu.edu.tr

+90 542 400 25 53

Burcu AKKURT, PhD

Role: CONTACT

burcu.akkurt@fbu.edu.tr

05536046713

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

63.2025fbu

Identifier Type: -

Identifier Source: org_study_id