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临床试验/NCT01952704
NCT01952704Unknown不适用

A Randomized Controlled Trial of Aerobic Exercise to Improve Memory in TBI

Kessler Foundation0 个研究点目标入组 24 人开始时间: 2013年10月1日最近更新:
适应症

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

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

发起方
Kessler Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria Leavitt

Research Scientist

Kessler Foundation

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