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Exercise Reset for Concussion in a Military Environment

Primary Purpose

Brain Concussion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion focused on measuring aerobic exercise, military, service member*, concussion management

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    No Intervention

    Experimental

    Arm Label

    Healthy Control Service Members

    Concussed Service Members PRA

    Concussed Service Members PRA+Exercise

    Arm Description

    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.

    CSM allocated to this group will complete PRA protocols/ will receive treatment as usual.

    CSM allocated to this group will complete PRA protocols/ will receive treatment as usual and will receive an exercise program in addition to PRA.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2022
    Last Updated
    October 12, 2023
    Sponsor
    State University of New York at Buffalo
    Collaborators
    United States Department of Defense, Children's Hospital of Philadelphia, University of Pennsylvania, University of North Carolina, Chapel Hill, The Geneva Foundation, Quadrant Biosciences Inc., Center for Neuroscience and Regenerative Medicine (CNRM), Axon Medical Technologies LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05498038
    Brief Title
    Exercise Reset for Concussion in a Military Environment
    Official Title
    Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2026 (Anticipated)
    Study Completion Date
    March 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of New York at Buffalo
    Collaborators
    United States Department of Defense, Children's Hospital of Philadelphia, University of Pennsylvania, University of North Carolina, Chapel Hill, The Geneva Foundation, Quadrant Biosciences Inc., Center for Neuroscience and Regenerative Medicine (CNRM), Axon Medical Technologies LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Concussion
    Keywords
    aerobic exercise, military, service member*, concussion management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a four-year multicenter mechanistic treatment (Phase 3) RCT that recruits CSM and healthy service members as controls. CSM who have signed a consent form to participate in the trial will be randomly assigned to either exercise+PRA or to PRA alone by the research assistant using a computer-generated randomization scheme generated by the study statistician. CSM will be allocated to trial arm using a pre-determined block randomization procedure in a 1:1 ratio, in multiples of 3 and limited to a maximum of 9, to reduce potential for imbalance across study arms. We will stratify the sample by sex and site and attempt to recruit a M:F ratio similar to the military in general (80:20). Randomization will occur without knowledge of the clinician who diagnosed the concussion. Data is collected at the first visit and weekly until clinical recovery, or up to 4 weeks from injury, and at the final 3 month time point. Controls will complete the clinic visits twice, two weeks apart.
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Control Service Members
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Concussed Service Members PRA
    Arm Type
    No Intervention
    Arm Description
    CSM allocated to this group will complete PRA protocols/ will receive treatment as usual.
    Arm Title
    Concussed Service Members PRA+Exercise
    Arm Type
    Experimental
    Arm Description
    CSM allocated to this group will complete PRA protocols/ will receive treatment as usual and will receive an exercise program in addition to PRA.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Aerobic Exercise
    Intervention Description
    Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.
    Primary Outcome Measure Information:
    Title
    Persistent Post Concussive Symptoms (PPCS) (Yes/No)
    Description
    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.
    Time Frame
    28 days
    Title
    Days until Recovery
    Description
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    John J Leddy, MD
    Phone
    716-829-5499
    Email
    leddy@buffalo.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared.

    Learn more about this trial

    Exercise Reset for Concussion in a Military Environment

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