High-Amplitude Functional Exercises in Older Adults With Mild Cognitive Impairment
2026年8月9日 更新者:Yunus Emre Tutuneken、Istinye University
Effects of Dual-Task-Based High-Amplitude Functional Exercises on Balance and Functional Mobility in Older Adults With Mild Cognitive Impairment
This study will investigate the effects of dual-task-based high-amplitude functional exercises on balance and functional mobility in older adults with mild cognitive impairment.
A total of 36 participants aged 65 years and older will be randomly assigned to either a high-amplitude functional exercise group or a traditional balance and mobility exercise group.
Both groups will participate in exercise sessions four times per week for four weeks, with each session lasting 60 minutes.
The effects of the exercise programs will be evaluated by assessing balance, functional mobility, dual-task performance, walking performance, fear of falling, and independence in daily activities before and after the intervention.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
36
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Living independently/actively in a nursing home.
- Diagnosis of Mild Cognitive Impairment (MCI) based on a standardized screening test, with a Montreal Cognitive Assessment (MoCA) score of 18-25.
- Ability to walk independently for at least 10 meters without an assistive device or with only a cane/single-point support.
- Sufficient vision and hearing capacity to follow dual-task instructions and exercise directions, which may be corrected with glasses or hearing aids.
- Stable medical condition that does not prevent participation in the exercise program throughout the study.
Exclusion Criteria:
- Diagnosis of dementia or severe cognitive impairment based on cognitive screening (MoCA <17).
- Neurological conditions that primarily affect balance, such as Parkinson's disease, residual effects of stroke, multiple sclerosis, or cerebellar ataxia.
- Severe osteoarthritis, active inflammatory joint disease, or a history of major orthopedic surgery within the previous 6 months that could limit exercise performance.
- Uncontrolled hypertension, heart failure (NYHA Class III-IV), or cardiopulmonary instability causing symptoms during exercise.
- Advanced vestibular pathology or severe loss of proprioception in the lower extremities that could be the primary cause of balance impairment.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Dual-Task-Based High-Amplitude Functional Exercise
|
Participants will receive a dual-task-based high-amplitude functional exercise program consisting of high-amplitude functional movements combined with progressively challenging cognitive tasks.
The program will be administered 4 times per week for 4 weeks, for a total of 16 sessions, with each session lasting 60 minutes.
Exercise intensity will be prescribed as maximal effort, corresponding to 7-8/10 on the Borg Rating of Perceived Exertion Scale.
The program will include seated and standing functional exercises, large-amplitude stepping movements, dynamic movements, large-amplitude walking, functional task activities, and complex functional tasks.
|
|
有源比较器:Traditional Balance and Mobility Exercise
|
Participants will receive a traditional balance and mobility exercise program administered 4 times per week for 4 weeks, for a total of 16 sessions, with each session lasting 60 minutes.
Exercise intensity will be moderate, corresponding to 4-5/10 on the Borg Rating of Perceived Exertion Scale.
The program will consist of motor tasks without cognitive dual-task components.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dual-Task Timed Up and Go Test
大体时间:Baseline to post-intervention (4 weeks)
|
The Dual-Task TUG will assess functional mobility under cognitive load by adding a cognitive task to the standard Timed Up and Go test.
Test performance will be recorded as the time required to complete the task.
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Baseline to post-intervention (4 weeks)
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Mini-BESTest
大体时间:Baseline to post-intervention (4 weeks)
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The Mini-BESTest will be used to assess balance performance across anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait.
The scale consists of 14 items scored from 0 to 2, with a maximum total score of 28.
Higher scores indicate better balance performance.
|
Baseline to post-intervention (4 weeks)
|
|
Five Times Sit-to-Stand Test
大体时间:Baseline to post-intervention (4 weeks)
|
The Five Times Sit-to-Stand Test will be used to assess lower-extremity muscle strength and functional capacity.
The time required to complete five full sit-to-stand repetitions will be recorded.
|
Baseline to post-intervention (4 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Timed Up and Go Test (TUG)
大体时间:Baseline to post-intervention (4 weeks)
|
The TUG will be used to assess functional mobility and dynamic balance.
|
Baseline to post-intervention (4 weeks)
|
|
Edinburgh Visual Gait Score
大体时间:Baseline to post-intervention (4 weeks)
|
The EVGS will be used to assess gait quality through observational analysis of gait kinematics across different anatomical segments.
|
Baseline to post-intervention (4 weeks)
|
|
Dual-Task Walking Speed
大体时间:Baseline to post-intervention (4 weeks)
|
Walking speed will be measured during a cognitive dual-task condition over a 10-meter walking course and recorded in meters per second.
|
Baseline to post-intervention (4 weeks)
|
|
Dual-Task Cost
大体时间:Baseline to post-intervention (4 weeks)
|
Dual-task cost will be calculated from the TUG performance using the formula.
|
Baseline to post-intervention (4 weeks)
|
|
Falls Efficacy Scale-International I
大体时间:Baseline to post-intervention (4 weeks)
|
The FES-I will be used to assess concerns about falling during daily activities.
Higher scores indicate greater fear of falling.
|
Baseline to post-intervention (4 weeks)
|
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Barthel Index
大体时间:Baseline to post-intervention (4 weeks)
|
The Barthel Index will be used to assess independence in basic activities of daily living, including eating, bathing, dressing, and transfers.
Scores range from 0 to 100, with higher scores indicating greater independence.
|
Baseline to post-intervention (4 weeks)
|
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Global Change Scale
大体时间:Post-intervention (4 weeks)
|
The Global Change Scale will be used to assess participants' perceived change following the intervention.
Participants will rate perceived change from -5 (much worse) to +5 (much better).
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Post-intervention (4 weeks)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月20日
初级完成 (估计的)
2027年4月5日
研究完成 (估计的)
2027年4月5日
研究注册日期
首次提交
2026年8月9日
首先提交符合 QC 标准的
2026年8月9日
首次发布 (实际的)
2026年8月13日
研究记录更新
最后更新发布 (实际的)
2026年8月13日
上次提交的符合 QC 标准的更新
2026年8月9日
最后验证
2026年8月1日
更多信息
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