Exercise and Rehabilitation After Traumatic Brain Injury
2018年1月26日 更新者：Grace S. Griesbach、Centre for Neuro Skills
Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
The purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury.
Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate recovery.
研究概览
详细说明
Exercise-based therapies can promote recovery of function and are easily implemented in the clinical rehabilitation setting.
This study will determine if exercise facilitates recovery by improving markers of neuroplasticity and decreasing neuroinflammatory responses.
The investigators will also determine if variations in genes involved in neuroplasticity, memory and inflammation influence the responsiveness to exercise and rehabilitation.
Particular genetic polymorphisms involved in neuroplasticity and inflammatory responses will be evaluated.
Recovery will be determined by assessing cognitive function, life quality and balance.
研究类型
介入性
注册 (预期的)
120
阶段
- 阶段1
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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California
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Encino、California、美国、91436
- 招聘中
- Centre for Neuro Skills
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接触：
- Grace Griesbach, PhD
- 电话号码：818-783-3800
- 邮箱：researchcentre@neuroskills.com
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接触：
- Charan Singh, MS
- 电话号码：(661)872-3408
- 邮箱：csingh@neuroskills.com
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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
18年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical diagnosis of TBI (for R+AER and R groups).
- Fluency in English or Spanish.
- Able to walk with or without a device.
Exclusion Criteria:
- Orthopedic or cardiac conditions that prevent from exercising.
- Current diagnosis of neurological and/or psychiatric diseases.
Unable to be in the Los Angeles CA metropolitan area for the duration of the study
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention aerobic exercise (AER)
Participants with traumatic brain injury (TBI) that are enrolled in a comprehensive rehabilitation program (R) will be engaged in an aerobic exercise program (AER).
These participants will also receive standard rehabilitation which includes exercise within the physical therapy session.
Given that the duration of the rehabilitative program is variable the period of AER training will be no less than 4 weeks and will not exceed 30 weeks.
Activity levels will be monitored.
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Aerobic exercise will be performed with a treadmill or stationary tandem bike 3 times per week.
Each exercise session will take about 30 minutes plus 5 to 10 min of warm-up and cool-down.
Participants will wear a safety harness.
康复计划的重点是每周在神经技能中心完成五天的日常生活、启蒙、适当的行为和社区融入活动。
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有源比较器：rehabilitation (R)
Participants with traumatic brain injury that are enrolled in a comprehensive rehabilitation program.
These participants will receive standard rehabilitation.
Given that the duration of the rehabilitative program is variable the duration of participation will be no less than 4 weeks and will not exceed 30 weeks.
Activity levels will be monitored.
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康复计划的重点是每周在神经技能中心完成五天的日常生活、启蒙、适当的行为和社区融入活动。
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无干预：control (C)
Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.
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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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Aerobic Exercise Induced Changes in Inflammatory responses to exercise
大体时间：4 to 30 weeks depending on the duration of rehabilitation coverage.
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Selected analytes will be evaluated from serum.
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4 to 30 weeks depending on the duration of rehabilitation coverage.
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Aerobic Exercise Induced Changes in Cognitive Function
大体时间：5 years
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Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs.
All scores are aggregated to one reported value (Neurocognitive Index).
Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.
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5 years
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Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness
大体时间：4 to 30 weeks depending on the duration of rehabilitation coverage.
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Ventilatory Threshold (aerobic capacity)
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4 to 30 weeks depending on the duration of rehabilitation coverage.
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Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise
大体时间：4 to 30 weeks depending on the duration of rehabilitation coverage.
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Selected analytes will be evaluated from serum.
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4 to 30 weeks depending on the duration of rehabilitation coverage.
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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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Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.
大体时间：4 to 30 weeks depending on the duration of rehabilitation coverage.
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Genetic material will be obtained.
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4 to 30 weeks depending on the duration of rehabilitation coverage.
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Aerobic Exercise Induced Changes in Depression Symptoms
大体时间：4 to 30 weeks depending on the duration of rehabilitation coverage.
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Beck Depression Inventory
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4 to 30 weeks depending on the duration of rehabilitation coverage.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Verbal Memory
大体时间：4 to 30 weeks depending on the duration of rehabilitation coverage.
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California Verbal Learning Test (CVLT II).
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4 to 30 weeks depending on the duration of rehabilitation coverage.
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Visual Search/Processing Speed
大体时间：4 to 30 weeks depending on the duration of rehabilitation coverage.
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Trail Making
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4 to 30 weeks depending on the duration of rehabilitation coverage.
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Quality of Life
大体时间：4 to 30 weeks depending on the duration of rehabilitation coverage.
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Quality of Life in Neurological Disorders (Neuro-QoL)
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4 to 30 weeks depending on the duration of rehabilitation coverage.
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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。
调查人员
- 首席研究员：Grace S Griesbach, PhD、Centre for Neuro Skills
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
- Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
- Griesbach GS, Hovda DA, Molteni R, Wu A, Gomez-Pinilla F. Voluntary exercise following traumatic brain injury: brain-derived neurotrophic factor upregulation and recovery of function. Neuroscience. 2004;125(1):129-39. doi: 10.1016/j.neuroscience.2004.01.030.
- Hellawell DJ, Taylor RT, Pentland B. Cognitive and psychosocial outcome following moderate or severe traumatic brain injury. Brain Inj. 1999 Jul;13(7):489-504. doi: 10.1080/026990599121403.
- Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.
- Chamelian L, Feinstein A. Outcome after mild to moderate traumatic brain injury: the role of dizziness. Arch Phys Med Rehabil. 2004 Oct;85(10):1662-6. doi: 10.1016/j.apmr.2004.02.012.
- Agrawal M, Joshi M. Impact of rehabilitation on functional outcome during the first year of moderate and severe traumatic brain injury. Brain Inj. 2014;28(3):292-7. doi: 10.3109/02699052.2013.865266. Epub 2013 Dec 30.
- Griesbach GS, Kreber LA, Harrington D, Ashley MJ. Post-acute traumatic brain injury rehabilitation: effects on outcome measures and life care costs. J Neurotrauma. 2015 May 15;32(10):704-11. doi: 10.1089/neu.2014.3754. Epub 2015 Feb 11.
- Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867.
- Ridgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):600-8. doi: 10.1177/1545968308328726. Epub 2009 Jan 8.
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
2016年6月1日
初级完成 (预期的)
2020年3月1日
研究完成 (预期的)
2022年3月1日
研究注册日期
首次提交
2015年7月9日
首先提交符合 QC 标准的
2018年1月16日
首次发布 (实际的)
2018年1月23日
研究记录更新
最后更新发布 (实际的)
2018年1月30日
上次提交的符合 QC 标准的更新
2018年1月26日
最后验证
2018年1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.
Aerobic Exercise (AER)的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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Istanbul UniversityIstanbul University Research Fund完全的