Comparative Effects of Integrated Versus Sequential Approaches to Dual-Task Training in Elderly With Mild to Moderate Cognitive Impairment: A Four-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Functional Mobility (Timed Up and Go Test) Change from Baseline in Timed Up and Go (TUG) Test Time at 8 Weeks
研究概览
简要总结
Mild and Moderate cognitive impairment is a condition characterized by a noticeable decline in cognitive abilities, including memory and thinking skills, which is greater than expected for an individual's age but does not significantly interfere with daily life. Early intervention is essential to prevent further cognitive decline and progression to dementia.
Dual-task training has emerged as an effective rehabilitation approach that combines cognitive and motor tasks to enhance neuroplasticity and improve both physical and cognitive performance. This study is designed to investigate the effectiveness of dual-task training compared to conventional therapy in individuals with mild cognitive impairment.
Participants meeting the inclusion criteria will be recruited and randomly allocated into intervention and control groups. The intervention group will receive structured dual-task training, which may include activities such as walking while performing cognitive tasks (e.g., counting, word recall), balance exercises combined with mental tasks, and functional activities requiring divided attention. The control group will receive standard rehabilitation or single-task training.
The intervention will be conducted over a specified duration (e.g., several weeks), with sessions held multiple times per week. Outcome measures will be assessed at baseline and after completion of the intervention. The primary outcome will be cognitive function measured using the Mini-Mental State Examination (MMSE). Secondary outcomes may include balance, mobility, and functional performance.
Data will be analyzed to determine the effectiveness of dual-task training in improving cognitive and functional outcomes. The results of this study may contribute to evidence-based rehabilitation practices and support the use of dual-task interventions in clinical settings.
详细描述
The elderly population is rapidly growing as a result of the global increase in life expectancy, and age-related cognitive disorders are becoming more common. Dementia has become a major public health concern that greatly contributes to disability, dependence, and a lower quality of life among older adults worldwide It is commonly acknowledged that mild cognitive impairment (MCI) is a stage that lies between dementia and normal cognitive aging. While independence in the most fundamental aspects of daily life is largely maintained, it is characterized by an apparent decline in cognitive abilities, especially memory and executive functions, early intervention is crucial because people with MCI continue to have an elevated risk of developing Alzheimer's disease Physical decline, such as decreased gait speed, balance issues, muscle weakness, and a high risk of falls, is often associated with cognitive impairment in elderly individuals. Since shared neural pathways support both motor and cognitive functions, these physical impairments are closely associated with cognitive dysfunction Elderly people's functional independence and quality of life are severely compromised when cognitive decline and physical decline coexist Pharmacological treatments for dementia and cognitive impairment provide only slight symptom relief and are ineffective at stopping the progression of the disease, despite advancements in medical management. Because of this restriction, research attention is now more focused on non-pharmacological strategies to improve functional outcomes and postpone cognitive decline Given their ability to address both cognitive and motor deficits at the same time, combined cognitive and physical training approaches have drawn more attention in this context One effective rehabilitation technique is dual-task training, which involves performing cognitive and motor tasks simultaneously or sequentially. This method places significant demands on attentional control and executive functioning and reflects functional demands found in real life, such as walking while completing a cognitive task. Dual-task training increases prefrontal cortical activation, boosts neural efficiency, and encourages neuroplastic adaptations that support cognitive and motor function, according to neurophysiological evidence There are two main ways to deliver motor-cognitive training: sequential (successive) dual-task training and integrated (simultaneous) dual-task training. The simultaneous performance of cognitive and motor tasks is necessary for integrated training, which may improve executive control by increasing cognitive-motor interference. By using different learning mechanisms, sequential training, on the other hand, enables concentrated attention to each task and may promote neural consolidation and task automation Even though both strategies have shown positive results, the research so far has produced inconsistent findings about how effective they are in comparison, especially when it comes to older people with various levels of cognitive impairment. Furthermore, there aren't many carefully planned multi-arm randomized controlled trials that compare integrated and sequential dual-task training in groups of people with mild to moderate cognitive impairment.
Therefore, the current study uses a four-arm randomized controlled trial design to compare the effects of integrated versus sequential dual-task training in senior citizen with mild to moderate cognitive impairment. This study aims to determine the best intervention approach for strengthening cognitive function, increasing mobility, and encouraging functional independence in this expanding and vulnerable population by assessing cognitive, physical, and functional outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
single-blind (assessor-blinded, if applicable)
入排标准
- 年龄范围
- 55 Months 至 85 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 55 years
- •MoCA: 10-25
- •MMSE: 10-23
- •Diagnosed cognitive impairment
- •Able to participate in training
排除标准
- •Severe cognitive impairment
- •Severe physical sensory limitations
- •Unstable medical conditions
- •Participation in other trials
研究组 & 干预措施
Integrated Dual-Task Training (Mild Cognitive Impairment)
Participants with mild cognitive impairment will receive integrated dual-task training, where motor and cognitive tasks are performed simultaneously. Training will be conducted for 8 weeks, 3 sessions per week, each lasting 45 minutes.
干预措施: Integrated Dual-Task Training (Behavioral)
Sequential Dual-Task Training (Moderate Cognitive Impairment)
Participants with moderate cognitive impairment will receive sequential dual-task training, involving separate motor and cognitive task performance. The program duration is 8 weeks, with 3 weekly sessions of 45 minutes each.
干预措施: Sequential Dual-Task Training (Behavioral)
Integrated Dual-Task Training (Moderate Cognitive Impairment)
Participants with moderate cognitive impairment will receive integrated dual-task training combining simultaneous motor and cognitive tasks. The intervention will last 8 weeks, with 3 sessions per week of 45 minutes each.
干预措施: Integrated Dual-Task Training (Behavioral)
Sequential Dual-Task Training (Mild Cognitive Impairment)
Participants with mild cognitive impairment will undergo sequential dual-task training, where motor and cognitive tasks are performed separately. Training will be conducted over 8 weeks, 3 sessions per week, 45 minutes per session.
干预措施: Sequential Dual-Task Training (Behavioral)
结局指标
主要结局
Functional Mobility (Timed Up and Go Test) Change from Baseline in Timed Up and Go (TUG) Test Time at 8 Weeks
时间窗: Baseline and after 8 weeks of intervention
Functional mobility will be evaluated using the Timed Up and Go (TUG) test. It measures the time (in seconds) taken by a participant to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower times indicate better mobility. Functional mobility and balance will be assessed using the Timed Up and Go (TUG) test, a simple and widely used clinical measure of mobility and fall risk. In this test, participants are required to stand up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better functional mobility and balance, while longer times indicate impaired mobility and increased risk of falls. A time of less than 10 seconds is considered normal for healthy adults, 10-19 seconds indicates good mobility, 20-29 seconds suggests variable mobility, and 30 seconds or more indicates impaired mobility and a higher risk of falls
Executive Function (Trail Making Test) Change from Baseline in Trail Making Test (Part A and Part B) Completion Time at 8 Weeks
时间窗: Baseline and after 8 weeks of intervention
Executive function will be assessed using the Trail Making Test (TMT Parts A and B), which evaluates cognitive flexibility, processing speed, and task-switching ability. Performance is measured by completion time in seconds. Cognitive function, specifically attention, processing speed, and executive function, will be assessed using the Trail Making Test (TMT). The test consists of two parts: Part A and Part B. In Part A, participants are required to connect numbered dots in sequential order as quickly as possible, assessing visual scanning and processing speed. In Part B, participants alternate between numbers and letters in sequence (e.g., 1-A-2-B), assessing executive function and task-switching ability. The outcome is measured as the time (in seconds) taken to complete each part. Longer completion times indicate poorer cognitive performance, while shorter times indicate better cognitive performance. The Trail Making Test will be administered at baseline and after completion of the
Global Cognitive Function (Montreal Cognitive Assessment) Change from Baseline in Montreal Cognitive Assessment (MoCA) Score at 8 Weeks
时间窗: Baseline and after 8 weeks of intervention
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). It evaluates multiple cognitive domains including attention, memory, language, visuospatial ability, and executive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a standardized screening tool designed to detect mild cognitive impairment. The MoCA evaluates multiple cognitive domains including attention, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance and lower scores indicating greater cognitive impairment. A score of 26 or above is generally considered normal cognitive function. The MoCA will be administered at baseline and after completion of the intervention period to assess changes in cognitive function.
Balance Performance (Berg Balance Scale) Change from Baseline in Berg Balance Scale (BBS) Score at 8 Weeks
时间窗: Baseline and after 8 weeks of intervention
Balance will be assessed using the Berg Balance Scale (BBS), a 14-item objective measure designed to assess static and dynamic balance abilities in older adults. Scores range from 0 to 56, with higher scores indicating better balance performance. Balance will be assessed using the Berg Balance Scale (BBS), a standardized clinical tool used to evaluate static and dynamic balance abilities. The BBS consists of 14 functional tasks, including sitting, standing, transferring, reaching, turning, and single-leg stance. Each item is scored on a 5-point scale ranging from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance, while lower scores indicate greater balance impairment and increased risk of falls. A score of 41-56 indicates low fall risk, 21-40 indicates medium fall risk, and 0-20 indicates high fall risk. The BBS will be administered at baseline and after completion of the intervention period to assess changes in balance performance.
Cognitive Function (Mini-Mental State Examination) Change from Baseline in Mini-Mental State Examination (MMSE) Score at 8 Weeks
时间窗: Baseline and after 8 weeks of intervention
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a widely used screening tool for cognitive impairment. The MMSE evaluates domains including orientation, registration, attention and calculation, recall, and language. Scores range from 0 to 30, with higher scores indicating better cognitive function. Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a widely used standardized tool for evaluating cognitive impairment. The MMSE assesses domains including orientation, registration, attention and calculation, recall, language, and visuospatial ability. The total score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment. A score of 24-30 is generally considered normal cognition, 18-23 indicates mild cognitive impairment, and 0-17 indicates severe cognitive impairment. MMSE will be administered at baseline and after completion
次要结局
- Quality of Life Change from Baseline in WHO Quality of Life-BREF (WHOQOL-BREF) Score at 6 Weeks(Baseline and after 8 weeks of intervention)
研究者
Fouzia Batool
Assistant Professor
Shifa Tameer-e-Millat University