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临床试验/NCT07163039
NCT07163039尚未招募不适用

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

Fenerbahce University0 个研究点目标入组 60 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Trail Making Test Part A (TMT-A)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Trail Making Test Part A (TMT-A)

时间窗: 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.

Stroop Test

时间窗: 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")

Trail Making Test Part B (TMT-B):

时间窗: 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…)

Montreal Cognitive Assessment (MoCA)

时间窗: 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

d2 Test of Attention

时间窗: 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.

次要结局

  • Symbol Digit Modalities Test (SDMT)(From enrollment to the end of treatment at 8 weeks)
  • Functional Near-Infrared Spectroscopy (fNIRS)(From enrollment to the end of treatment at 8 weeks)
  • Disability Assessment for Dementia (DAD)(From enrollment to the end of treatment at 8 weeks)
  • Dual Task Protocol(From enrollment to the end of treatment at 8 weeks)
  • Performance Measures: Walking speed(From enrollment to the end of treatment at 8 weeks)
  • Performance Measures: Step count(From enrollment to the end of treatment at 8 weeks)
  • Performance Measures: Number of correct response Number of correct responses(From enrollment to the end of treatment at 8 weeks)
  • Performance Measures: incorrect response(From enrollment to the end of treatment at 8 weeks)
  • Gait Analysis System: Walking speed during single-task walking(From enrollment to the end of treatment at 8 weeks)
  • Gait Analysis System: Step length during single-task walking(From enrollment to the end of treatment at 8 weeks)
  • Gait Analysis System:Balance during dual-task walking(From enrollment to the end of treatment at 8 weeks)
  • Gait Analysis System: Postural control during dual-task walking(From enrollment to the end of treatment at 8 weeks)
  • Electromyography (EMG)(From enrollment to the end of treatment at 8 weeks)

研究者

发起方
Fenerbahce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu AKKURT

Assistant Professor

Fenerbahce University

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