NCT05786729Enrolling By Invitation1 期
Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
适应症
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline
研究概览
简要总结
The purpose of this study is to examine the effects of individualized aerobic exercise regimen on recovery after traumatic brain injury (TBI).Investigators will determine if exercise facilitates recovery by facilitating neuroplasticity and decreasing neuroinflammation.
详细描述
Exercise-based therapies can promote recovery of function and are easily implemented in the clinical rehabilitation setting. This study will determine if exercise facilitates recovery by improving markers of neuroplasticity and decreasing neuroinflammatory responses. The investigators will also determine if variations in genes involved in neuroplasticity, and inflammation influence the responsiveness to exercise and rehabilitation. Recovery will be determined by assessing cognitive function, life quality and balance.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants will provide informed consent and have to comply with the procedures of the study.
- •Age will range from 18 to 60 years.
- •Except for the non-injured control group, subjects will be required to have experienced TBI.
- •All participants should be fluent in English or Spanish.
- •All participants should have the ability to comply with the research protocol.
- •Capable of exercising in aerobic exercise equipment (with or without trunk support).
- •Able to walk independently with or without a device
排除标准
- •Current diagnosis of degenerative neurological disease.
- •A history of cerebral vascular accidents.
- •A history of major psychosis as defined by DSM-IV.
- •Subjects receiving physical therapy in a location that is not CNS.
- •Pregnancy.
- •A history of previous TBI requiring hospitalization.
- •Inability to cooperate
- •Orthopedic impairment that compromises exercise performance
- •Any cardiovascular or respiratory condition that jeopardizes patient health during exercise.
结局指标
主要结局
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline
时间窗: Baseline
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 4
时间窗: Week 4
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Aerobic Exercise Induced Changes in Cardio Pulmonary (CPET) at Week 12
时间窗: Week 12
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at Week 8
时间窗: Week 8
CPET will allow us to determine oxygen consumption (VO2). Results will be reported as change in VO2 levels.
次要结局
- Aerobic Exercise Induced Changes in Cognitive Function at Week 12(Week 12)
- Aerobic Exercise Induced Changes in Cognitive Function at Week 4(Week 4)
- Aerobic Exercise Induced Changes in Cognitive Function at Week 8(Week 8)
- Aerobic Exercise Induced Changes in Cognitive Function at baseline(Baseline)
- Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at baseline(Baseline)
- Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 4(Week 4)
- Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 12(Week 12)
- Quality of Life Measured by the NeuroQOL at baseline(Baseline)
- Quality of Life Measured by the NeuroQOL at Week 4(Week 4)
- Verbal Memory Assessed by the California Verbal Learning Test (CVLT II) at Week 8(Week 8)
- Quality of Life Measured by the NeuroQOL at Week 8(Week 8)
- Quality of Life Measured by the NeuroQOL at Week 12(Week 12)
- Depression measured by the Beck Depression Inventory-II at baseline(Baseline)
- Depression measured by the Beck Depression Inventory-II at Week 4(Week 4)
- Visual Search/ Processing Speed measured by Trail Making Test (TMT) at baseline(Baseline)
- Sleepiness will be measured by the Epworth Sleepiness Scale at Week 4(Week 4)
- Vestibular function will be measured by the Berg Balance Test at Week 4(Week 4)
- Depression measured by the Beck Depression Inventory-II at Week 8(Week 8)
- Depression measured by the Beck Depression Inventory-II at Week 12(Week 12)
- Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 4(Week 4)
- Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 12(Week 12)
- Sleepiness will be measured by the Epworth Sleepiness Scale at baseline(Baseline)
- Visual Search/ Processing Speed measured by Trail Making Test (TMT) at Week 8(Week 8)
- Sleepiness will be measured by the Epworth Sleepiness Scale at Week 8(Week 8)
- Sleepiness will be measured by the Epworth Sleepiness Scale at Week 12(Week 12)
- Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at baseline(Baseline)
- Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 4(Week 4)
- Vestibular function will be measured by the Berg Balance Test at baseline(Baseline)
- Vestibular function will be measured by the Berg Balance Test at Week 12(Week 12)
- Vestibular function will be measured by the Berg Balance Test at Week 8(Week 8)
- Evaluation of Inflammatory Biomarkers at Week 4(Week 4)
- Evaluation of Inflammatory Biomarkers at Week 8(Week 8)
- Evaluation of Inflammatory Biomarkers at Week 12(Week 12)
- Evaluation of Neuroplasticity, Stress Biomarkers at Baseline(Baseline)
- Evaluation of Neurodegeneration Biomarkers at Week 4(Week 4)
- Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 8(Week 8)
- Evaluation of Neuroplasticity, Stress Biomarkers at Week 8(Week 8)
- BDNF / Val66Met at Week 8(Week 8)
- Aerobic capacity and endurance will be measured with the 6 Minute Walk Test at Week 12(Week 12)
- Evaluation of Neuroplasticity, Stress Biomarkers at Week 4(Week 4)
- Evaluation of Neuroplasticity, Stress Biomarkers at Week 12(Week 12)
- Evaluation of Neurodegeneration Biomarkers at Week 8(Week 8)
- Evaluation of Neurodegeneration Biomarkers at Week 12(Week 12)
- Evaluation of Inflammatory Biomarkers at Baseline(Baseline)
- Evaluation of Neurodegeneration Biomarkers at Baseline(Baseline)
- BDNF / Val66Met at baseline(Baseline)
- BDNF / Val66Met at Week 4(Week 4)
- BDNF / Val66Met at Week 12(Week 12)
- IL-1β / rs16944 at baseline(Baseline)
- IL-1β / rs16944 at Week 4(Week 4)
- IL-1β / rs16944 at Week 8(Week 8)
- IL-1β / rs16944 at Week 12(Week 12)
- TrkB at baseline(Baseline)
- COMT / VAll58Met at Week 4(Week 4)
- COMT / VAll58Met at Week 12(Week 12)
- DRD2 / A to T & A to G at baseline(Baseline)
- ANKKI / TAQIA at baseline(Baseline)
- ANKKI / TAQIA at Week 12(Week 12)
- PPPIRIB / C to T at baseline(Baseline)
- TrkB at Week 4(Week 4)
- TrkB at Week 8(Week 8)
- TrkB at Week 12(Week 12)
- COMT / VAll58Met at baseline(Baseline)
- COMT / VAll58Met at Week 8(Week 8)
- DRD2 / A to T & A to G at Week 8(Week 8)
- DRD2 / A to T & A to G at Week 4(Week 4)
- DRD2 / A to T & A to G at Week 12(Week 12)
- ANKKI / TAQIA at Week 4(Week 4)
- PPPIRIB / C to T at Week 4(week 4)
- 5-HTR2A / AI438G at Week 4(Week 4)
- 5-HT1A / C1019G at baseline(Baseline)
- 5-HT1A / C1019G at Week 12(Week 12)
- 5-HTR2B / HTR2B Q20 at Week 8(Week 8)
- ANKKI / TAQIA at Week 8(Week 8)
- MAO-A /MAOA-H & MAOA-L at baseline(Baseline)
- MAO-A /MAOA-H & MAOA-L at Week 4(Week 4)
- PPPIRIB / C to T at Week 8(week 8)
- MAO-A /MAOA-H & MAOA-L at Week 8(Week 8)
- MAO-A /MAOA-H & MAOA-L at Week 12(Week 12)
- 5-HTR2A / AI438G at baseline(Baseline)
- 5-HTR2A / AI438G at Week 8(Week 8)
- 5-HT1A / C1019G at Week 4(Week 4)
- PPPIRIB / C to T at Week 12(week 12)
- 5-HTR2A / AI438G at Week 12(Week 12)
- 5-HT1A / C1019G at Week 8(Week 8)
- 5-HTR2B / HTR2B Q20 at baseline(Baseline)
- TPH / A218C & A779C at Week 4(Week 4)
- TPH / A218C & A779C at Week 12(Week 12)
- 5-HTR2B / HTR2B Q20 at Week 4(Week 4)
- 5-HTR2B / HTR2B Q20 at Week 12(Week 12)
- TPH / A218C & A779C at baseline(Baseline)
- TPH / A218C & A779C at Week 8(Week 8)
研究者
Grace S. Griesbach
National Director of Clinical Research
Centre for Neuro Skills
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Aerobic Exercise in People With Post-COVID-19COVID-19NCT05302973Istituti Clinici Scientifici Maugeri SpA30
尚未招募
1 期
Effect of Aerobic Exercise Approach on Recovery Patients with Pain SymptomsFemoral neck fracture or femoral condyle fractureD019637JPRN-jRCT1030230052Kaneko Junichiroh10
已完成
不适用
Exercise to Improve Outcomes of Treatment for Methamphetamine UsersAddictionNCT01103531University of California, Los Angeles135
已完成
不适用
The effect of aerobic physical rehabilitation on the quality of life of patients with atrial fibrillatio???????? ???? ??????.Atrial fibrillation and flutterIRCT2016122727073N2Isfahan Medical Science University50
已完成
不适用
Examining Different Modes of Exercise for Acute Reduction in Blood PressureHypertensionNCT06628635University of Saskatchewan10