Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 4
- 主要终点
- Persistent Post Concussive Symptoms (PPCS) (Yes/No)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •For the HC group:
- •Has lingering symptoms from a previous concussion or has recovered from a concussion less than 1-month ago
- •On a limited profile or "chit" for light duty
- •Active substance abuse/dependence
- •Unwilling to perform intervention
- •Limited English proficiency
- •Confirmed pregnancy
- •Inclusion Criteria (Providers):
- •Active duty
- •Currently active clinician (MD, DO, PT, ATC, OT) involved in concussion management beyond initial emergent diagnosis
- •Willing to participate
- •Able to be contacted by telephone or Zoom
- •Exclusion Criteria (Providers):
- •Not active duty
- •Not currently an active clinician (MD, DO, PT, ATC, OT) involved in concussion management
- •Only involved in concussion management at emergent timepoint
- •Unwilling to participate
- •Unable to be contacted by telephone or Zoom
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.
次要结局
未报告次要终点
研究者
John J. Leddy MD
John J Leddy, MD
State University of New York at Buffalo