Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Brain Concussion
- 发起方
- State University of New York at Buffalo
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Persistent Post Concussive Symptoms (PPCS) (Yes/No)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery. We will conduct a prospective four-year multicenter mechanistic treatment (Phase 3) RCT in CSM of personalized sub-threshold aerobic exercise added to the PRA compared with the PRA alone. Non-concussed, age-matched SM will serve as a healthy control group (HC) for comparing CSM to normal physiology and to control for the effect of time and of aerobic exercise.
详细描述
Aim 1: Determine whether early sub-threshold aerobic exercise (i.e., light limited duty) added to the current Department of Defense Progressive Return to Activity \[DoD PRA\]) protocol speeds return to duty (RTD), improves clinical recovery, and protects against risk of persistent post-concussive symptoms (PPCS). Hyp 1.1: Aerobic exercise+DoD PRA early after injury speeds RTD and improves clinical recovery in CSM compared to the DoD PRA protocol alone. Hyp 1.2: Early aerobic exercise+DoD PRA protects against risk of PPCS in concussed service members (CSM) at 1 and at 3 months post-injury versus the DoD PRA protocol alone. Aim 2: Determine whether a March-in-place test informs clinical decision-making and contributes to RTD decisions. Hyp 2.1: The degree of early exercise intolerance on the Buffalo Concussion March Test (BCMT) will correlate with the development of PPCS and inform clinician decision making on RTD. Aim 3: Determine how aerobic exercise improves concussion recovery. Hyp 3.1: Aerobic exercise improves abnormal autonomic nervous system (ANS) regulation in CSM. Hyp 3.2: Aerobic exercise improves expression of salivary brain-derived neurotrophic factor (BDNF), BDNF-related miRNAs, and inflammatory-related miRNAs seen in CSM. Hyp 3.3: Aerobic exercise improves mental health (i.e., anxiety/depressive symptoms, sleep, resilience, self-efficacy, morale) in CSM. Aim 4: Evaluate the suitability of the Exercise RESET testing and intervention approach for military use informed by study participants and providers.
研究者
John J. Leddy MD
John J Leddy, MD
State University of New York at Buffalo
入排标准
入选标准
- •(Participants):
- •For the CSM Group:
- •Active-duty service member
- •Aged 18-40 years
- •Injury occurred within 9 days of injury
- •Diagnosed with concussion by an experienced clinician using standard international criteria
- •For the HC Group:
- •Active-duty service member
- •Ages 18-40
排除标准
- •(Participants):
- •For the CSM group:
- •Moderate or severe TBI as indicated by a GCS score \<13, lesion on CT/MRI, and/or focal neurologic sign consistent with intracerebral lesion
- •Injury involving loss of consciousness for \>30 minutes or post-traumatic amnesia \>24 hours
- •Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk
- •Pre-existing conditions that prevent participation in active testing and/or rehabilitation
- •Active substance abuse/dependence
- •Unwillingness to perform intervention
- •Limited English proficiency
- •Confirmed pregnancy
结局指标
主要结局
Persistent Post Concussive Symptoms (PPCS) (Yes/No)
时间窗: 28 days
PPCS is defined as recovery more than 28 days from the day of concussive injury (yes) or before 28 days (no). Recovery is defined as return to baseline symptoms, exercise tolerant and confirmation by independent medical examination.
Days until Recovery
时间窗: 3 months
Determination of clinical recovery will be made by a clinician. Each week we will use a multi-modal assessment to establish clinical recovery, which is defined as return to a pre-injury level of symptoms, a normal physical examination and exercise tolerant on the graded exercise assessment.