Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment
2019年7月11日 更新者：Chang Gung Memorial Hospital
Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study
This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment.
The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.
研究概览
详细说明
Background and study aims:
Mild cognitive impairment (MCI) or minor neurocognitive disorder is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The age-adjusted prevalence of MCI in Taiwan is approximately 18%, while women have higher prevalence for MCI than men. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in 5 years. Therefore, early detection of the individuals who manifest MCI and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Previous studies found that cognitive training or exercise has emerged as an important therapeutic approach for individuals with MCI. However, the intervention effects of combining exercise and cognitive training remain to be determined. Furthermore, whether exercise and cognitive training should be administered in sequential order or simultaneously is an important question to pursue. The overall goal of this study is to determine and compare the intervention effects cognitive training, exercise, and combining cognitive and exercise training in individuals with MCI.
Who can participate? Individuals with MCI.
What does the study involve? The participants will receive a total of 36 training sessions, and each session will contain 90 minutes of training. Training frequency will be 2-3 times per week for 12-18 weeks. All participants will received pretreatment test, post treatment test, and a 6-month follow-up test.
What are the possible benefits and risks of participating? The possible benefits include improvement in cognitive, physical, and daily functions. There are no risks for participating.
Where to conduct the study? The investigators anticipate recruiting a total of 80 participants from geriatric day care centers and nursing homes from multiple cities in Taiwan.
研究类型
介入性
注册 (实际的)
55
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Taipei City、台湾、249
- Baliexcelsior Nursing Home
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Taichung、台湾、412
- Pine nursing home
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Taipei、台湾、11150
- Zhishan community home
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Taipei、台湾、11165
- Bailing clinics and nursing homes
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Taipei、台湾、111
- Shihlin cum day care center
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Taipei、台湾、11443
- Xihu day care center
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Taipei、台湾
- TaoSheng Nursing home
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Taoyuan、台湾、333
- Chang Gung Memorial Hospital
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Taoyuan、台湾
- Chang Gung Memorial Hospital Taoyuan branch
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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
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- able to follow instruction,
- clinical dementia rating (CDR) = 0.5 or 1,
- self- or informant-reported memory or cognitive complaint, and
- able to perform activities of daily living (Barthel Index ≥ 70).
Exclusion Criteria:
- recent myocardial infarction,
- heart failure,
- recent heart surgery,
- severe asthma,
- concomitant with other neurological disorders, or
- joint deformity that might prevents them performing exercise or cognitive training.
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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有源比较器：Cognitive training group (Cog)
The BrainHQ program will be used to train different cognitive functions of the participants.
The participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions.
The tasks will become more difficult as the participants progress in their abilities.
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visuospatial, attention, memory, and executive abilities
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有源比较器：Physical exercise group (PE)
The participants in this group participate in multimodal exercise programs including aerobic exercise, balance, and strength training.
The entire exercise program for the PE group will contain 10 minutes of warm-up, 70 minutes of physical exercise, and 10 minutes of cool-down.
The 70 minutes of exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period.
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endurance, balance, and mobility
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实验性的：Sequential training group (Seq)
The participants in this group will first perform 45 minutes of physical exercise followed by 45 minutes of cognitive training.
The physical exercise training will be similar to the programs used in the PE group.
The entire exercise program for the PE group will contain 5 minutes of warm-up, 35 minutes of physical exercise, and 5 minutes of cool-down.
The cognitive training will be implemented with BrainHQ similar to what has been described in the COG group.
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visuospatial, attention, memory, and executive abilities
endurance, balance, and mobility
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实验性的：Dual-task training group (Dual)
In this group, the participants will be instructed to perform physical exercise and cognitive tasks simultaneously (e.g., math calculation while stepping).
The difficulty of the cognitive tasks will increase as the participants improve in their performance.
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visuospatial, attention, memory, and executive abilities
endurance, balance, and mobility
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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 |
|---|---|---|
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Change scores of Montreal Cognitive Assessment (MoCA)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The MoCA will be used to assess general cognitive functions.
It examines several cognitive domains with a total score of 30.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Stroop test
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities.
The participants will be tested under 2 conditions: congruent and incongruent conditions.
In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Dual-task test
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously.
The investigators will assess the dual-task performance during walking and performing box and block test.
The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Timed up and go (TUG) test
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The TUG test will be used to assess the mobility and dynamic balance ability.
The participants will be required to stand up from a chair, walk 3 meters, turn around, then walk back to the chair, and sit down.
The time to complete the TUG test has been shown to be a good indicator to detect potential fallers and frail elderly (Podsiadlo & Richardson, 1991).
The test-retest reliability of TUG on individuals with cognitive impairment was excellent (Blankevoort, van Heuvelen, & Scherder, 2013).
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change scores of the Verbal Fluency Test
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Verbal fluency tests will be used to evaluate the semantic memory of the participants.
The participants will be instructed to say as many words as possible from a given category (i.e., fruit or animal) in 1 minute.
The validity, reliability, and normative performance of verbal fluency tests have been well-established (Harrison, Buxton, Husain, & Wise, 2000).
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Useful Field of View (UFOV)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Useful field of view (UFOV) is the visual area over which useful information could be obtained at a quick glance without eye or head movements.
This UFOV will be assessed with the BrainHQ program.
The UFOV will assess the abilities of visuomotor processing speed, divided attention, and selective attention (Ball, Edwards, & Ross, 2007).
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the 30 second chair stand test (CST)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The 30 second chair stand test (CST) will be assessed to indicate the strength and endurance level of the lower extremities.
The participants will be asked to stand up from a standardized chair and then sit down as many times as possible within 30 seconds.
The feasibility and reliability of using CST in people with cognitive impairment have been established to be good (Blankevoort et al., 2013).
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Chinese version of the International Physical Activity Questionnaires (IPAQ)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The Chinese version of the International Physical Activity Questionnaires (IPAQ) is an international measure for health-related physical activity.
A short form of IPAQ will be used to assess changes in physical activity before and after intervention in this study.
The reliability and validity of IPAQ has been established across 12 countries (Craig et al., 2003).
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Barthel Index (BI)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Assess activities of daily living
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Lawton Instrumental Activities of Daily Living Scale
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Assess activities of daily living.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Disability Assessment for Dementia (DAD)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Assess activities of daily living.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The Chinese version of QoLAD will be used.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Caregiver Burden Inventory (CBI)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The Chinese version of CBI will be used.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Geriatric Depression Scale (GDS)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The Chinese version of short form GDS will be used.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the Community Integration Questionnaire (CIQ)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The CIQ measures items relevant to home integration, social integration, and productive activities.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of the ActiGraph GX3 accelerometers Change scores of the ActiGraph
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The actigraphy will be placed on the waist for a 3-day period immediately before and after the intervention.
The participants will wear the actigraphy during all daily activities except for those that involve water (i.e., showering or swimming).
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of evaluating isometric knee flexors and extensors muscle strength
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The participant will be seated upright in a chair with back support, the knee will be placed in 90-degree flexion and the evaluator will stabilize the thing to eliminate synergistic movements.
Participants will be asked to perform a maximal isometric contraction of knee flexion and extension with both lower extremities.
The investigators will record the mean value of 3 attempts.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of using hand dynamometer to measure grip strength of both hand
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
|
The participant is seated, with the elbow at 90-degree flexion.
The investigators will record the mean value of 3 attempts.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The investigators will use the WMS-III subtests, including Faces Recognition (score range 0-48), Verbal Paired Associates (score range 0-32), Word Lists (0-48), and Spatial Span (0-32) to assess the immediate, delayed, and working memory tests.
Higher scores indicated better performance for each subtest.
The raw score of each subtest will also be transferred to standardized Z scores and summed to represent an index of general memory function.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
大体时间：baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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The WAIS-III includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed.
The subtests that the investigators will use are the Digit Symbol-Coding (scores range 0-133) and Matrix Reasoning tests (0-26).
The raw score of each subtest will also be transferred to standardized Z scores and summed to represent an index of general cognitive function.
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baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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BDNF val66met genotype
大体时间：baseline
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Saliva samples will be collected at baseline to determine the Brain-Derived Neurotrophic Factor (BDNF) val66met genotype.
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baseline
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2015年1月30日
初级完成 (实际的)
2018年1月29日
研究完成 (实际的)
2019年3月13日
研究注册日期
首次提交
2015年7月20日
首先提交符合 QC 标准的
2015年7月29日
首次发布 (估计)
2015年7月31日
研究记录更新
最后更新发布 (实际的)
2019年7月12日
上次提交的符合 QC 标准的更新
2019年7月11日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.