NCT00571545已完成不适用
The Effect of Exercise on Mood After Traumatic Brain Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory
研究概览
简要总结
We proposed to examine the effect of an aerobic exercise intervention on depression in persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury who are assigned to receive the exercise intervention with those in the control group to determine the effect of exercise on levels of depression and specific symptoms related to depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise on activity, participation level, and quality of life will be examined.
HYPOTHESES:
- Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.
- Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning.
- Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.
- Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic brain injury 1-5 years prior to enrollment
- •Current depression as measured by a score of 5 or greater on the depression portion of the Physician Health Questionnaire (PHQ).
- •Sufficient cognitive ability to maintain participation in the study
- •Sufficient English language ability to allow participation without an interpreter
排除标准
- •Current suicidal ideation with intent or plan
- •Currently pregnant
- •History of significant cardiovascular or respiratory disease
- •History of significant cardiovascular or respiratory disease
- •Physical barriers to the use of standard aerobic exercise equipment
结局指标
主要结局
Beck Depression Inventory
时间窗: 10 week
次要结局
未报告次要终点
研究者
Kathleen Bell
Professor, Department of Rehabilitative Medicine
University of Washington
研究点 (2)
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