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临床试验/NCT03256643
NCT03256643Unknown不适用

Cognitive and Physical Effects of Exercise or Exercise With Enrichment on People With TBI

Wayne State University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
42
试验地点
1
主要终点
Trail Making Part B

研究概览

简要总结

The purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. The enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk. A series of tests that measure mental function and balance will be done before and after the exercise or the exercise/enrichment program will be done to measure efficacy.

详细描述

Traumatic brain injury (TBI) results in long-lasting physical and cognitive deficits. The purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. The environmental enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk on 8 different cultures. Individuals will be evaluated using neuropsychological and physical tests before and after the intervention. Testing will consist of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trailmaking Test (TMT), Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Quality of Life in Brain Injury Questionnaire (QOLIBRI), 10 meter walk, and the NIH Toolbox Standing Balance Test. Initial testing will include the Disability Rating Scale to help balance groups (after random assignment) in terms of baseline ability.

In rodents, exercise or an enriched environment after TBI improve cognitive function and motor function and the combination results in even greater improvement. The mechanism of cognitive improvement from exercise or environmental enrichment relates to increases in brain derived neurotrophic factor and neurogenesis in the hippocampus. An additional possible mechanism of the positive effects of exercise or enrichment is a reduction in inflammation. Our hypothesis is that exercise or exercise with enrichment will result in better motor performance and improved cognitive ability.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Traumatic brain injury (TBI) person
  • •1 to 15 year post-TBI
  • •Initial Glascow Coma SCale (GCS) of < or = 12
  • •18-75 years old
  • •able to perform standardized exercise program

排除标准

  • •Inability to walk independently without assistive aids.
  • •Severe cardiovascular limitations limiting exercise of up to 5 metabolic equivalents.

研究组 & 干预措施

Exercise

Experimental

Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.

干预措施: Exercise (Behavioral)

Delayed Exercise

Experimental

Delayed Exercise Group will have exercise as intervention. People be tested before the start of, and after the end of the eight (8) weeks then after exercise intervention.

干预措施: Delayed Exercise (Behavioral)

Exercise and Enrichment

Experimental

Exercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program.

干预措施: Exercise and enrichment (Behavioral)

结局指标

主要结局

Trail Making Part B

时间窗: Change from Baseline at 9 weeks.

Trail Making test is a measure of visual conceptual and visuomotor tracking, attention, and maintenance of cognitive set-shifting that is known to be highly sensitive to brain damage.

次要结局

  • Quality of Life in Brain Injury Questionnaire(Change from Baseline at 9 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jay M Meythaler

Professor of Medicine with Tenure

Wayne State University

研究点 (1)

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