A Randomized Controlled Trial of Aerobic Exercise to Improve Memory in TBI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 主要终点
- Hippocampal volume
研究概览
简要总结
Aerobic exercise holds a multitude of health benefits. Studies in mice have shown that aerobic exercise improves memory, and increases the volume of the hippocampus, the brain's primary memory center. Only two studies have been conducted in humans, one in healthy elders, and the other in a schizophrenia population. So far, there has never been an aerobic exercise trial in traumatic brain injury (TBI) to look at hippocampal volume and memory as outcomes of interest. The proposed project is a randomized controlled trial of aerobic exercise in persons with TBI. We will conduct a 12-week (36 sessions) program of aerobic exercise (stationary cycling), versus a control condition of non-aerobic exercise (stretching), in memory-impaired TBI patients to a) increase hippocampal volume and b) improve memory. Importantly, we also expect benefits of aerobic exercise on the level of brain function. Specifically, we will look at 'functional connectivity,' which refers to how efficiently remote regions of the brain 'talk' to each other. TBI is an ideal population to benefit from aerobic exercise, given the young age at which many individuals sustain TBI, which allows for benefits of aerobic exercise to be maximally realized in a population with sufficient neurofunctional reserve. The expected benefits of aerobic exercise (increased hippocampal volume, improved memory) from this intervention stand to have a meaningful impact on people with TBI, including improved health, productivity, independence, and quality of life. And, unlike current treatments for memory impairment (e.g., pharmacological agents, cognitive rehabilitation), aerobic exercise is a cost-effective, all natural, readily-available treatment for memory problems.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TBI greater than or equal to 1 year
- •MRI compatibility
- •Right Handed
排除标准
- •Reported lower body weakness or use of an assistive device for walking
- •History of pulmonary disease, heart disease, vascular disease of the legs, high blood pressure
- •History of stroke, other neurological disease/disorder, serious psychiatric illness
- •Engaging in more than 30 minutes of aerobic exercise per week
- •Current use of steroids, benzodiazepines, and/or neuroleptics
- •History of substance abuse
结局指标
主要结局
Hippocampal volume
时间窗: 1 week post intervention
Volumetric software will be used to measure hippocampus at baseline and follow-up (within 1 week of completion of 12-week intervention).
次要结局
未报告次要终点
研究者
Victoria Leavitt
Research Scientist
Kessler Foundation
