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Forced Aerobic Exercise for Stroke Rehabilitation

2018年12月20日 更新者：Susan Linder、The Cleveland Clinic
The purpose of the study is to determine if performing different types of aerobic exercise (cycling) before upper extremity exercises will help to improve outcomes after stroke.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The goal of this study is to determine the potential for forced aerobic exercise to augment the recovery of motor function in individuals with stroke. Current approaches to stroke rehabilitation involve intensive, therapist-directed task practice that is both expensive and in some cases, ineffective in fostering functional neuromotor recovery. The identification of a safe, cost-effective approach, such as forced aerobic exercise, to augment the recovery of function achieved through task practice while simultaneously decreasing the cardiovascular risk factors prevalent in stroke survivors would be significant to rehabilitation and stroke communities.

Animal studies along with preliminary human data indicate a specific type of aerobic exercise (AE), forced aerobic exercise (FE), may be ideal in facilitating motor recovery associated with repetitive task practice (RTP). The hypothesis is that that deficits in afferent input and motor cortical output following stroke prevents patients from achieving and maintaining an exercise intensity that is sufficient for facilitating motor recovery; therefore, FE is needed to augment their voluntary efforts and achieve greater gains in recovery. In previous research, a safe lower extremity FE intervention was initially applied to individuals with Parkinson's disease and subsequently to individuals with stroke. Preliminary results indicate that those completing an 8-week FE intervention paired with an abbreviated session of RTP exhibited significantly greater improvement in Fugl-Meyer scores at end of treatment despite completing 40% fewer RTP repetitions, compared to those receiving voluntary-rate aerobic exercise (VE) and RTP and time-matched RTP only. Improvements in cardiovascular fitness and lower extremity motor function were also evident in both groups that engaged in aerobic exercise (FE and VE). Positive results from a preliminary trial indicate safety, feasibility, and initial efficacy of combining two modes of aerobic exercise training with RTP provide rationale for a systematic and larger scale trial to determine the precise role of aerobic exercise, forced and voluntary, in facilitating motor recovery following stroke.

For this study, 30 individuals with chronic stroke will be randomized into one of the following groups: FE = RTP, VE + RTP or patient education and RTP. All three groups will receive an identical dose of contact time over 8 weeks (3X per week). An intervention group receiving a 45-minute session of patient education paired with RTP will serve as the non-exercise control. Clinical and biomechanical outcomes measuring change in upper extremity motor function, lower extremity motor function, and cardiovascular fitness will provide the most complete picture, to date, on the potential neurologic effects of AE (forced and voluntary) on motor recovery and brain function in humans with stroke.

研究类型

介入性

注册 (实际的)

34

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

  • 美国
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic

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

18年 至 85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:

  • Able to provide informed consent
  • At least 6 months post diagnosis of single ischemic stroke, confirmed with neuroimaging
  • Fugl-Meyer Motor Score 19-55 in involved upper extremity
  • Approval from patient's physician
  • Age between 18 and 85 years

Exclusion Criteria:

  • Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment
  • Serious cardiac arrhythmia
  • Other serious heart and lung conditions (i.e.cardiomyopathy, aortic stenosis, cardiac pacemaker, pulmonary embolus)
  • Other medical or musculoskeletal contraindication to exercise
  • Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation
  • Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment
  • Pregnancy
  • Unstable blood pressure at rest or with exercise

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：Forced Exercise & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
  2. 45 minutes of upper extremity repetitive arm exercises
行为的：Forced Exercise & Upper Extremity Repetitive Task Practice
有源比较器：Voluntary Exercise & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
  2. 45 minutes of upper extremity repetitive arm exercises
行为的：Voluntary Exercise & Upper Extremity Repetitive Task Practice
有源比较器：Stroke Education & Upper Extremity Repetitive Task Practice

Participants will perform the following:

  1. 45 minutes of stroke education
  2. 45 minutes of upper extremity repetitive arm exercises
行为的：Stroke Education & Upper Extremity Repetitive Task Practice

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
Fugl Meyer Assessment
大体时间：Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.
Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Wolf Motor Function Test
大体时间：Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Stroke Impact Scale
大体时间：Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Metabolic Stress Test
大体时间：Change from baseline to follow up assessments at end of 8 week intervention
Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.
Change from baseline to follow up assessments at end of 8 week intervention

次要结果测量

结果测量
措施说明
大体时间
Action Research Arm Test
大体时间：Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Center for Epidemiological Studies-Depression
大体时间：Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Processing Speed Test
大体时间：Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Matching letters and symbols to test cognition. The reported data is change in total number correct.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Nine Hole Peg Test
大体时间：Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Six Minute Walk Test
大体时间：Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

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

The Cleveland Clinic

合作者

American Heart Association

调查人员

  • 首席研究员：Susan Linder, PT, DPT, NCS、The Cleveland Clinic

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7月1日

初级完成 (实际的)

2017年8月1日

研究完成 (实际的)

2017年8月1日

研究注册日期

首次提交

2015年7月6日

首先提交符合 QC 标准的

2015年7月8日

首次发布 (估计)

2015年7月10日

研究记录更新

最后更新发布 (实际的)

2019年3月28日

上次提交的符合 QC 标准的更新

2018年12月20日

最后验证

2018年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 12-402

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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