Aerobic Exercise in TBI: White Matter Integrity and Cognition
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Diffusion Tensor Imaging
研究概览
简要总结
The current project will examine the effects of aerobic exercise on cognition among a group of veterans who have suffered a mild traumatic brain injury.
详细描述
There is substantial evidence that a large number of individuals who experience TBI will demonstrate life-long deficits in cognitive or social functions. An estimated 80-90,000 Americans with TBI suffer life-long impairment of physical, cognitive, and psychosocial skills to the degree that they are unable to return to school or work. Research on rehabilitation for mTBI has been minimal and typically has focused on speech, pain management, dizziness, fatigue, irritability, and sensory disorders. The results of the few studies that have examined long-term cognitive effects of mTBI have offered conflicting results. The current research will investigate the efficacy of an aerobic exercise intervention among individuals with mild traumatic brain injury (mTBI). This project will examine changes in fractional anisotropy (FA) values and cognitive functioning among individuals diagnosed with mTBI in a monitored aerobic exercise regimen, versus a low impact stretching and toning control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anyone between 18 and 50 years of age,
- •from the geographic region served by the Malcolm Randall-North Florida-South Georgia VAMC,
- •who have sustained a TBI and demonstrate impairment on neuropsychological assessment (criteria for mTBI will be defined as a loss of consciousness for not more than 30 minutes and post-trauma amnesia of not more than 24 hours).
排除标准
- •TBI occurring less than 6 months or greater than 5 years prior to enrollment,
- •any metal implants or shrapnel that may put them at risk for injury during an MRI scan,
- •significant cognitive impairment (MMSE<24),
- •history of stroke,
- •B-12 deficiency,
- •hypothyroidism,
- •organ failure (renal, hepatic, cardiac, or lung),
- •substance abuse,
- •seizures,
- •or any limitation that would preclude them from safely engaging in the aerobic exercise regimen.
结局指标
主要结局
Diffusion Tensor Imaging
时间窗: 16 weeks
次要结局
- Hand Dynamometer(16 weeks)
- Controlled Oral Word Association Test (COWAT).(16 weeks)
- Grooved Pegboard Test(16 weeks)
- Brief Visual Memory Test - Revised (BVMT-R).(16 weeks)
- Delis-Kaplin Executive Function System Tower Test(16 weeks)
- Boston Naming Test (BNT).(16 weeks)
- Continuous Performance Test of Attention (CPT-A).(16 weeks)
- Adaptive Digit Ordering Test (DOT-A).(16 weeks)
- Judgment-Line Orientation (JLO).(16 weeks)
- Finger Tapping Test(16 weeks)
- Trail Making Test - Part A(16 weeks)
- Symbol Search(16 weeks)
- Trail Making Test - Part B.(16 weeks)
- California Verbal Learning Test - Second Edition (CVLT-II).(16 weeks)