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Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline

2016年12月19日 更新者：Chang Gung Memorial Hospital

Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline

The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.

研究概览

地位

未知

条件

干预/治疗

研究类型

介入性

注册 (预期的)

75

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

  • 台湾
      • Chiayi City、台湾、613
        • 招聘中
        • Chiayi Chang Gung Memorial Hospital
        • 接触：
      • Kaohsiung City、台湾、83301
        • 招聘中
        • Kaohsiung Chang Gung Memorial Hospital
        • 接触：
      • Keelung City、台湾、204
        • 招聘中
        • Keeling Chang Gung Memorial Hospital
        • 接触：
      • Taipei City、台湾、105
        • 招聘中
        • Taipei Chang Gung Memorial Hospital
        • 接触：
      • Taoyuan City、台湾、333
        • 招聘中
        • Taoyuan Chang Gung Memorial Hospital
        • 接触：
    • Taoyuan
      • Kwei-Shan、Taoyuan、台湾、333
        • 招聘中
        • Chang Gung Memorial Hospital

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 至 90年 (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:

  1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
  2. Age range from 20 to 90 years
  3. MMSE score ≥ 19
  4. MoCA<26
  5. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
  6. Able to follow the study instruction
  7. Adequate cardiopulmonary function to perform aerobic exercise
  8. Able to walk with or without assistive devices

Exclusion Criteria:

  1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
  2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
  3. Current participation in another interventional trial

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
有源比较器：Cognitive training group
One 60-min session of cognitive training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
行为的：认知训练
有源比较器：Aerobic exercise training group
One 60-min session of aerobic exercise training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
行为的：Aerobic exercise training
实验性的：Sequential training group

One 30-min session of aerobic exercise training + one 30-min session of cognitive training.

Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
行为的：Sequential combination of aerobic exercise and cognitive training

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
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)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Useful Field of View (UFOV)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroop Color-Word test
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Dual-task test
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

次要结果测量

结果测量
措施说明
大体时间
改变抗氧化标记的分数
大体时间：基线、后测（预期平均 3 个月）
抗氧化标记物将用于反映氧化应激的变化。 特别是，我们将分析总抗氧化能力 (TAC)。
基线、后测（预期平均 3 个月）
血浆脂质水平的变化分数
大体时间：基线、后测（预期平均 3 个月）
将评估胆固醇比率（总胆固醇除以高密度脂质）以反映血液中的脂质水平。
基线、后测（预期平均 3 个月）
Change scores of serum BDNF level
大体时间：Baseline, posttest (an expected average of 3 months)
Baseline, posttest (an expected average of 3 months)
Change scores of Glucose indicator
大体时间：Baseline, posttest (an expected average of 3 months)
HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise.
Baseline, posttest (an expected average of 3 months)
Change scores of Functional Independence Measure (FIM)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroke Impact Scale (SIS)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Caregiver Burden (CB) scale
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of EuroQol (EQ)-5D questionnaire
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Timed up and go test (TUG)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Six-minute walk test (6MWT)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Mobility level
大体时间：Baseline, posttest (an expected average of 3 months)
Baseline, posttest (an expected average of 3 months)
Change scores of International Physical Activity Questionnaires (IPAQ)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Fugl-Meyer Assessment (FMA)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Rivermead Mobility Index (RMI)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of muscle strength
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer. Also, we will use hand dynamometer to measure grip strength of the affected and less affected hand while the participant is seated, with the elbow at 90-degree flexion. We will record the mean value of 3 attempts.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Community Integration Questionnaire (CIQ)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Geriatric Depression Scale (GDS)
大体时间：Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Genotyping of the BDNF val66met polymorphism
大体时间：Between baseline and posttest (an expected average of 3 months)
Between baseline and posttest (an expected average of 3 months)

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。

赞助

Chang Gung Memorial Hospital

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。

一般刊物

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

2015年9月1日

初级完成 (预期的)

2018年8月1日

研究注册日期

首次提交

2015年9月6日

首先提交符合 QC 标准的

2015年9月14日

首次发布 (估计)

2015年9月16日

研究记录更新

最后更新发布 (估计)

2016年12月20日

上次提交的符合 QC 标准的更新

2016年12月19日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 104-4892A3

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.

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