Exercise Reset for Concussion in a Military Environment

Официальное название

Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Aerobic Exercise
  Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.

Первичные конечные точки

• Persistent Post Concussive Symptoms (PPCS) (Yes/No) [Срок оценки: 28 days]
• Days until Recovery [Срок оценки: 3 months]
• Neurobehaviorial Symptom Inventory-22 (NSI) [Срок оценки: 4 years]
• Average weekly Physical Activity time [Срок оценки: 4 years]
• Buffalo Concussion March-in-place Test (BCMT) [Срок оценки: 4 years]
• Daily Symptom Score Severity [Срок оценки: 4 years]
• Average Nightly Sleep Quality [Срок оценки: 4 years]

Вторичные конечные точки (12)

• Concentration of Salivary BDNF [Срок оценки: 4 years]
• Salivary miRNA [Срок оценки: 4 years]
• National Institute of Neurological Disorders Scale (NIHSS) [Срок оценки: 4 years]
• Stroke Patient Reported Outcomes and Measurement Information System (PROMIS) scale [Срок оценки: 4 years]
• The Health Care Climate Questionnaire (HCCQ) [Срок оценки: 4 years]
• PTSD- Military Checklist (PCL-M) [Срок оценки: 4 years]
• Brief Resilience Survey (BRS) [Срок оценки: 4 years]
• Army Command Climate Survey [Срок оценки: 4 years]
• Cervical Range of Motion [Срок оценки: 4 years]
• Joint Position Error (JPE) [Срок оценки: 4 years]
• The Butterfly Test [Срок оценки: 4 years]
• Heart Rate Variability (HRV) milliseconds [Срок оценки: 4 years]

Критерии участия

Inclusion Criteria (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

Exclusion Criteria (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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Fort Liberty — Fayetteville
• Camp LeJeune — Jacksonville

Идентификаторы

NCT: NCT05498038 · TP210003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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