Exercise Reset for Concussion in a Military Environment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Concussion
• Intervention / Treatment: Behavioral: Aerobic Exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John J Leddy, MD; Phone Number: 716-829-5499; Email: leddy@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy Control Service Members; 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. They will not be given intervention.
No Intervention: Concussed Service Members PRA; CSM allocated to this group will complete PRA protocols/ will receive treatment as usual.
Experimental: Concussed Service Members PRA+Exercise; CSM allocated to this group will complete PRA protocols/ will receive treatment as usual and will receive an exercise program in addition to PRA.	Behavioral: Aerobic Exercise; Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: aerobic exercise; military; service member*; concussion management
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: TP210003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No