Comparing Symptom Provocation and Physiological Response Between Buffalo Concussion Treadmill Test (BCTT) Protocol and Modified Dynamic Exertion Test (mEXiT) Post Concussion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Physiological response to dynamic or aerobic test (HEART RATE)
研究概览
简要总结
This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit.
详细描述
The Buffalo Concussion Treadmill Test is a well established test to determine intensity of exercise without significant symptoms provocation after sport related concussion.
This study will help determine if there is a difference in type of symptom response between the two tests, due to the dynamic changes of direction and strain on the vestibular system with the m-EXiT group. The investigators hypothesize there will not be a significant difference between the two groups in time to clearance to return to sport despite allowing for higher symptoms earlier on in recovery.
High school athletes who have been diagnosed with a sport-related concussion will be randomly assigned to complete either the BCTT or the modified dynamic EXiT test (m-EXiT). The BCTT group will follow the established protocol and exercise to an increase of 2/10 symptoms on a visual analog scale (VAS) or 17/20 on rate of perceived effort (RPE) scale. The m-EXiT test will complete a shortened version of the dynamic EXiT test, but will stop if participants have an increase of greater than 4 points of headache, dizziness or nausea or RPE of 17/20. Symptoms, heart rate, and RPE will be measured through out both tests as well as Post-Concussion Symptom Scale (PCSS), Vestibular Ocular Motors Screening (VOMS), blood pressure and heart rate will be administered before and after testing. The time (in days) to recovery, will also be recorded from the medical record to determine if there is a difference between the two groups.
The primary outcome for the study will be symptoms post test and heart rate. Secondary measures include: Post Concussion Symptom Score (PCSS), Clinical Profiles Screening (CP-Screen), Vestibular Ocular Motor Screening (VOMS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder - 7 (GAD-7) and blood pressure. These will be collected at one visit with participants, there are no follow-up or subsequent visits for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a sport related concussion within 14 days of injury
- •Participants referred to exertion therapy after a trained clinician from University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program has interpreted neurocognitive, vestibular, and clinical interview outcomes and determined the participant is capable of completing structured exercise.
排除标准
- •Medically cleared from a previous concussion within the past 6 months
- •More than 2 previous concussions (excluding current injury)
- •History of brain surgery or traumatic brain injury (TBI) (based on Glasgow Coma Scale of <13)
- •History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations)
- •Current history of pre-existing vestibular disorder or oculomotor condition
- •Currently taking antidepressant, anticoagulant, beta-blocker, or anticonvulsant prescription medications
- •Incapable of treadmill running up to 5.5 miles per hour (mph) and 4.5 mph for males and females respectively (self-reported).
- •Diagnosed with a cardiac, peripheral, or cerebrovascular disease (type 1 or 2 diabetes, or renal disease.
- •Experienced chest pain or shortness of breath while at rest or with mild exertion.
- •Lose balance because of dizziness or have lost consciousness (aside from concussion) from exertion
- •Currently have (or have had within the past 12 months) a bone, joint, or soft tissue (muscle, ligament, or tendon) problem that could be made worse by physical activity
- •Been told by a doctor to only conduct physical activity under medical supervision.
研究组 & 干预措施
Buffalo Concussion Treadmill Test (BCTT)
Participants in this group will complete the Buffalo Concussion Treadmill Test (BCTT). This involves individuals walking at 5.8 km/hr. (3.6 mph) at a 0.0% incline (5.1 km/hr. [3.2 mph] if below 5' 10" tall), the treadmill incline is increased 1 degree each minute for the first 15 minutes, then speed increased 0.64 km/hr. (0.4 mph) each minute thereafter.
干预措施: BCTT (Other)
Modified EXiT Test (mEXiT)
Participants in this group will complete the modified EXiT test (mEXiT). Participants will complete a 12 minute treadmill interval program followed by a dynamic circuit (10 squat jumps, 10 side to side push ups and 10 medicine ball rotations), jump ball toss, zig zag agility and arrow agility. Parameters will be recorded the same as the established dynamic EXiT test; heart rate and RPE will be recorded at 0, 2, 6:30 and 12 minutes of the treadmill program as well as after the second trial of each activity. The time to complete two trials of the zig zag agility and arrow agility will also be recorded.
干预措施: Dynamic ExIT (Other)
结局指标
主要结局
Physiological response to dynamic or aerobic test (HEART RATE)
时间窗: Visit 1 (baseline) (pre, during, and post testing) 90 minutes
Participants will have their heart rate taken before the exercise protocol, then monitored throughout the test and after they complete the BCTT or mEXiT.
Physiological response to dynamic or aerobic test (SYMPTOM PROVOCATION)
时间窗: Visit 1 (baseline) (pre and post testing) 90 minutes
Participants will report on a Likert scale ranging from 0-10 (10 being severe) for headache, dizziness, and nausea, and provide a rating of perceived exertion (RPE) on a Borg scale ranging from 6 to 20 before and after completion of the BCTT or mEXiT.
次要结局
- Post Concussion Symptom Scale(Visit 1 Baseline (60-90 minutes), participants only complete one visit)
- Patient Health Questionnaire (PHQ-9)(Visit 1 Baseline (60-90 minutes), participants only complete one visit)
- Generalized Anxiety Disorder (GAD-7)(Visit 1 Baseline (60-90 minutes), participants only complete one visit)
- Vestibular Ocular Motor Screening (VOMS)(Visit 1 Baseline (pre and post testing 60-90 minutes), participants only complete one visit)
- Clinical Profiles Screening (CP-Screen)(Visit 1 Baseline (60-90 minutes), participants only complete one visit)
- Blood Pressure(Visit 1 Baseline (pre and post testing 60-90 minutes), participants only complete one visit)
研究者
Anthony P. Kontos, Ph.D.
Professor, Research Director University of Pittsburgh Concussion Lab
University of Pittsburgh