Exercise Reset for Concussion in a Military Environment

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05498038
• Other study ID #: TP210003
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2024
• Source: State University of New York at Buffalo
• Contact: John J Leddy, MD
• Phone: 716-829-5499
• Email: leddy[@]buffalo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 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 regulation in CSM.

Hyp 3.2: Aerobic exercise reverses changes in salivary brain-derived neurotrophic factor (BDNF), BDNF-related micro RNAs, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Aged 18-40 years,

• Within 9 days of injury

• Diagnosed with concussion by an experienced clinician using standard international criteria

Exclusion Criteria:

• 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

• History of more than 3 diagnosed concussions

• Currently on medications that affect autonomic function, such as ADHD medication or mood stabilizers

• Active substance abuse/dependence

• Unwillingness to perform intervention

• Limited English proficiency.

Related Conditions & MeSH terms

• Brain Concussion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Axon Medical Technologies LLC, Center for Neuroscience and Regenerative Medicine (CNRM), Children's Hospital of Philadelphia, Quadrant Biosciences Inc., The Geneva Foundation, United States Department of Defense, University of North Carolina, Chapel Hill, University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent Post Concussive Symptoms (PPCS) (Yes/No)	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.	28 days
Primary	Days until Recovery	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.	3 months