Exercise Training in Depressed Traumatic Brain Injury Survivors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- completion of exercise protocol
研究概览
简要总结
The purpose of this study is to determine the feasibility of successfully delivering moderate intensity aerobic exercise training to depressed traumatic brain injury subjects between one and three years after injury.
详细描述
Traumatic brain injury (TBI) alters the lives of many civilians and those involved in armed conflicts. Sequelae of TBI includes depression in up to 30% of cases. Appearance of depression after TBI impairs recovery and results in sub-optimal re-integration into society. Treatment of post TBI depression relies on oral medications, whose efficacy and side effect profile is sub-optimal. Exercise training is effective in spontaneous depression as a stand alone treatment and in conjunction with oral medications, and this may represent an alternative treatment option in the TBI population. Further, the pathophysiology of depression after TBI has yet to be examined with the full scientific rigor required. This project proposes to use exercise training of moderate intensity as a treatment for depression after TBI, while measuring biological markers as a way to investigate efficacy and provide insight into the pathophysiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT brain with subdural hematoma, subarachnoid hemorrhage, and/or cortical contusion
- •Glasgow outcome scale extended of 4 to 8
- •speaks English
- •Beck Depression Inventory -II score between 14 and 28
- •sedentary life style
- •one to three years after traumatic brain injury
排除标准
- •prior history of brain process (example, stroke, brain tumor)
- •psychosis, mania, bipolar disorder, schizophrenia
- •pregnancy
- •inability to exercise via cycles or treadmill
结局指标
主要结局
completion of exercise protocol
时间窗: 12 weeks
The primary aim is to measure the rate of completion of the exercise protocol.
次要结局
- Columbia-Suicide Severity Rating Scale(week 0, week 13, and weekly during 12 week intervention)
- biochemical assays(week 0, week 13)
- neuropsychological testing(pre and post intervention, week zero and week 13)
- mood assessment(week 0, week 13, and weekly during 12 week intervention)
- magnetic resonance imaging(week 0, week 13)