Brain ConcussionNCT05498038
Exercise Reset for Concussion in a Military Environment
A study testing Aerobic Exercise in people with Brain Concussion, run by State University of New York at Buffalo at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 12Show fewer
- Active-duty service member
- Ages 18-40
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fort Liberty
Fayetteville, North Carolina, 28310
Camp LeJeune
Jacksonville, North Carolina, 28547
About this study
Official title: 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. 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.
Read the 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 (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.
- Conditions
- Brain Concussion
- Being tested
- Aerobic Exercise
- Keywords
- concussion, military, aerobic exercise, recovery, return to duty
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Participants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Service Members | No intervention | 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. All HC participants will be provided with an activity monitor (with GPS tracking disabled) to wear 24 hours/day for measurement of daily physical activity and sleep duration over the time between first and final test sessions. The activity monitor also acts as an HR monitor to record the participants' HR during their prescribed exercise bouts. HC will be asked to exercise each day at approximately 70% of their age-predicted maximum heart rate (from the formula 220 minus age x 0.7 = target HR) for 20 minutes to control for the effect of exercise on the physiological tests. |
| Concussed Service Members PRA | No intervention | CSM randomized to PRA alone will receive written instructions on how to follow the PRA protocol. All participants will be provided with an activity monitor (with GPS tracking disabled), and we will record daily physical activity and sleep patterns. |
| Concussed Service Members PRA+Exercise | Experimental | CSM randomized to aerobic exercise+PRA will receive their individualized aerobic exercise prescription plus written instructions on how to follow the PRA protocol. CSM will start the exercise program the day after the first visit. All participants will be reminded each day by text message to complete their assigned activity (in the case of exercise + PRA participants, to perform their exercise at the prescribed dose [HR]) and to report any adverse effects). All participants will also report symptoms once daily in response to a text message to their phone. All participants will wear an activity monitor continuously until clinical recovery or for 4 weeks to measure daily activity and sleep. The activity monitor will also act as an HR monitor and will be worn by participants in the PRA+aerobic exercise group during daily exercise sessions to measure participant adherence to the prescribed exercise dose. Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Neurobehaviorial Symptom Inventory-22 (NSI)
To assess ongoing concussion symptoms, one of the main outcomes of the study. The NSI is a 5-minute measure validated in military populations to characterize concussion symptoms, endorsed by VA/DoD as a core TBI outcome measure. We will also use the symptom scale of the NSI to ask CSM about symptoms that existed before the concussion.
Measured: 4 years
Average weekly Physical Activity time
Average of activity time per day over one week (hours:minutes) - Physical activity is measured using Polar Coach to control for this potential mediator of concussion recovery. Activity time in duration per day (hours:minutes) is tracked and then manually averaged and recorded via a standardized Excel spreadsheet.
Measured: 4 years
Buffalo Concussion March-in-place Test (BCMT)
Average total steps per day over one week- Physical activity is measured using Polar Coach to control for this potential mediator of concussion recovery. Total steps per day are tracked and then manually averaged and recorded via a standardized Excel spreadsheet.
Measured: 4 years
Daily Symptom Score Severity
Daily Symptom Score Severity will be measured using Ecological Momentary Assessment (EMA) (RECOUPS) - Measure daily symptoms to control for this potential mediator of concussion recovery. Participants report their symptom score once daily in response to text messages sent to their smartphone.
Measured: 4 years
Average Nightly Sleep Quality
Measure sleep quality using Polar Coach to control for this potential mediator of concussion recovery. Duration of sleep time, sleep start time, sleep end time, and sleep restlessness score of each sleep session are tracked. Average sleep time per night, average sleep continuity, and average sleep continuity percentages are recorded via a standardized Excel spreadsheet and summated to generate a sleep quality score which will be analzyed.
Measured: 4 years
Secondary outcomes (20)
Concentration of Salivary BDNF
Concentration of salivary BDNF will be collected and used as a measure to assess enhanced neuroplasticity as a possible mechanism for the effect of aerobic exercise treatment on concussion.
Measured: 4 years
Salivary miRNA
Concentration of salivary miRNA will be collected and used as a measure to assess enhanced neuroplasticity as a possible mechanism for the effect of aerobic exercise treatment on concussion.
Measured: 4 years
National Institute of Neurological Disorders Scale (NIHSS)
We will collect brief validated measures of anxiety and depression to assess improved mental health as a potential mechanism for the effect of aerobic exercise treatment on concussion. Low scores indicate no deficit in neurological symptoms; high scores indicate severe deficits in neurological symptoms, and values range from 0 to 42.
Measured: 4 years
Stroke Patient Reported Outcomes and Measurement Information System (PROMIS) scale
We will collect brief validated measures of anxiety and depression to assess improved mental health as a potential mechanism for the effect of aerobic exercise treatment on concussion. Higher scores compared to the general population via standardized T-Scores indicate impairments, and values range from 20 to 80.
Measured: 4 years
The Health Care Climate Questionnaire (HCCQ)
We will collect brief validated health care related measures that follow Self - Determination Theory. The HCCQ measures the degree an individual feels autonomy-supported or controlled within the healthcare context, with higher scores indicating more autonomy and support felt. The range of scores is 15 to 105.
Measured: 4 years
PTSD- Military Checklist (PCL-M)
We will collect brief validated health care related measures that follow Self - Determination Theory. The PCL-M measures the degree an individual exhibits PTSD symptoms, with higher scores indicating higher likelihood of PTSD. The range of scores is from 17 to 85.
Measured: 4 years
Brief Resilience Survey (BRS)
We will measure resilience using this scale, which has been used to evaluate the effect on concussion recovery after sport- related concussion. Higher scores indicate more resilience, and scores range from 6 to 30.
Measured: 4 years
Army Command Climate Survey
We will use this scale to measure morale. Higher scores indicate higher feelings of morale in units, and scores range from 2 to 10.
Measured: 4 years
Cervical Range of Motion
Cervical Range of Motion (ROM) in degrees will be measured using the NeckCare device, an electronic medical device worn on the head to provide reliable assessments. Range of values is based on individual ability, with lower values indicating less ROM and higher values indicating more ROM.
Measured: 4 years
Joint Position Error (JPE)
Joint Position Error (JPE) in degrees will be measured using the NeckCare device, an electronic medical device worn on the head to provide reliable assessments. Range of values is based on individual ability, with lower values indicating more precise proprioceptive capabilities, and higher values indicating less precise proprioceptive capabilities.
Measured: 4 years
The Butterfly Test
Movement sense and eye-head-neck coordination using a score to control values will be measured using the NeckCare device, an electronic medical device work on the head to provide reliable assessments. Range of values is based on individual abilities compared to standard values, with lower values indicating more precise proprioceptive capabilities, and higher values indicating less precise proprioceptive capabilities.
Measured: 4 years
Heart Rate Variability (HRV) milliseconds
HRV, measured as R-R intervals in ms, will be measured using the Elite HRV app 5 minutes pre-post exercise. This will be used to assess parasympathetic autonomic function as a possible mechanism for the beneficial effect of aerobic exercise treatment.
Measured: 4 years
The rate of HR recovery after the BCMT in beats per minute (BPM)
The difference in HR from the immediate cessation of exercise to two minutes post-exercise will be used to assess parasympathetic autonomic function as a possible mechanism for the beneficial effect of aerobic exercise treatment.
Measured: 4 years
Pupillary reaction time
Pupillary reaction (time in milliseconds) will be assessed using the Intellig-eyes system. This will be used to assess parasympathetic autonomic function as a possible mechanism for the beneficial effect of aerobic exercise treatment.
Measured: 4 years
Pupil diameter change
Pupil diameter change will be measured in mm assessed using the Intellig-eyes system. This will be used to assess parasympathetic autonomic function as a possible mechanism for the beneficial effect of aerobic exercise treatment.
Measured: 4 years
Convergence rate millseconds
Convergence rate (in ms) will be assessed using the Intellig-eyes system. This will be used to assess parasympathetic autonomic function as a possible mechanism for the beneficial effect of aerobic exercise treatment.
Measured: 4 years
Time of Completion wioth the King Devick (KD) pre and post-exercise
We will use the KD test to assess for exercise-induced vision dysfunction (EIVD). Higher time (in seconds) indicates more dysfucntion indicative of concussion.
Measured: 4 years
Number of errors on the King Devick (KD) pre and post-exercise
We will use the KD test to assess for exercise-induced vision dysfunction (EIVD). Higher number of errors indicates more dysfunction indicative of concussion.
Measured: 4 years
Run/roll/aim task
We will use the run/roll/aim task to assess symptom change pre and post high demand vestibular activity.
Measured: 4 years
Suitability of Exercise RESET
Study participants who complete test procedures will be invited to participate in a semi-structured interview with the intention to learn about how the intervention worked or did not work for and to get feedback about how the intervention might be improved for implementation in a military environment. On site providers who engage in concussion care will also be invited for a separate semi-structured interview to provide insights on the acceptability of the Buffalo Protocol in the military health care setting.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start7 Aug 2024
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Children's Hospital of Philadelphia, University of Pennsylvania, University of North Carolina, Chapel Hill, The Geneva Foundation, Center for Neuroscience and Regenerative Medicine (CNRM), Axon Medical Technologies LLC
- Responsible party
- Principal investigator, John J. Leddy MD, State University of New York at Buffalo
- Investigators
- John Leddy, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498038
- Sponsor's protocol ID
- TP210003
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Reset for Concussion- Modifying the Buffalo Concussion Protocol for Application in a Military Environment
- ClinicalTrials.gov ID
- NCT05498038
- Acronym / sponsor ID
- TP210003
- Conditions
- Brain Concussion
- Keywords
- concussion, military, aerobic exercise, recovery, return to duty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- United States Department of Defense, Children's Hospital of Philadelphia, University of Pennsylvania, University of North Carolina, Chapel Hill, The Geneva Foundation, Center for Neuroscience and Regenerative Medicine (CNRM), Axon Medical Technologies LLC
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Service Members | No intervention | –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. All HC participants will be provided with an activity monitor (with GPS tracking disabled) to wear 24 hours/day for measurement of daily physical activity and sleep duration over the time between first and final test sessions. The activity monitor also acts as an HR monitor to record the participants' HR during their prescribed exercise bouts. HC will be asked to exercise each day at approximately 70% of their age-predicted maximum heart rate (from the formula 220 minus age x 0.7 = target HR) for 20 minutes to control for the effect of exercise on the physiological tests. |
| Concussed Service Members PRA | No intervention | –CSM randomized to PRA alone will receive written instructions on how to follow the PRA protocol. All participants will be provided with an activity monitor (with GPS tracking disabled), and we will record daily physical activity and sleep patterns. |
| Concussed Service Members PRA+Exercise | Experimental | Behavioral: Aerobic ExerciseCSM randomized to aerobic exercise+PRA will receive their individualized aerobic exercise prescription plus written instructions on how to follow the PRA protocol. CSM will start the exercise program the day after the first visit. All participants will be reminded each day by text message to complete their assigned activity (in the case of exercise + PRA participants, to perform their exercise at the prescribed dose [HR]) and to report any adverse effects). All participants will also report symptoms once daily in response to a text message to their phone. All participants will wear an activity monitor continuously until clinical recovery or for 4 weeks to measure daily activity and sleep. The activity monitor will also act as an HR monitor and will be worn by participants in the PRA+aerobic exercise group during daily exercise sessions to measure participant adherence to the prescribed exercise dose. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
- Active-duty service member
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseParticipants are asked to complete at least 20 minutes of aerobic exercise every day, excluding clinic visits. | Behavioural | Concussed Service Members PRA+Exercise |
Primary outcome
Persistent Post Concussive Symptoms (PPCS) (Yes/No)
Time frame: 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
Time frame: 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.
Neurobehaviorial Symptom Inventory-22 (NSI)
Time frame: 4 years
To assess ongoing concussion symptoms, one of the main outcomes of the study. The NSI is a 5-minute measure validated in military populations to characterize concussion symptoms, endorsed by VA/DoD as a core TBI outcome measure. We will also use the symptom scale of the NSI to ask CSM about symptoms that existed before the concussion.
Average weekly Physical Activity time
Time frame: 4 years
Average of activity time per day over one week (hours:minutes) - Physical activity is measured using Polar Coach to control for this potential mediator of concussion recovery. Activity time in duration per day (hours:minutes) is tracked and then manually averaged and recorded via a standardized Excel spreadsheet.
Buffalo Concussion March-in-place Test (BCMT)
Time frame: 4 years
Average total steps per day over one week- Physical activity is measured using Polar Coach to control for this potential mediator of concussion recovery. Total steps per day are tracked and then manually averaged and recorded via a standardized Excel spreadsheet.
Daily Symptom Score Severity
Time frame: 4 years
Daily Symptom Score Severity will be measured using Ecological Momentary Assessment (EMA) (RECOUPS) - Measure daily symptoms to control for this potential mediator of concussion recovery. Participants report their symptom score once daily in response to text messages sent to their smartphone.
Average Nightly Sleep Quality
Time frame: 4 years
Measure sleep quality using Polar Coach to control for this potential mediator of concussion recovery. Duration of sleep time, sleep start time, sleep end time, and sleep restlessness score of each sleep session are tracked. Average sleep time per night, average sleep continuity, and average sleep continuity percentages are recorded via a standardized Excel spreadsheet and summated to generate a sleep quality score which will be analzyed.
20 secondary outcomes
Concentration of Salivary BDNF
Time frame: 4 years
Salivary miRNA
Time frame: 4 years
National Institute of Neurological Disorders Scale (NIHSS)
Time frame: 4 years
Stroke Patient Reported Outcomes and Measurement Information System (PROMIS) scale
Time frame: 4 years
The Health Care Climate Questionnaire (HCCQ)
Time frame: 4 years
PTSD- Military Checklist (PCL-M)
Time frame: 4 years
Brief Resilience Survey (BRS)
Time frame: 4 years
Army Command Climate Survey
Time frame: 4 years
Cervical Range of Motion
Time frame: 4 years
Joint Position Error (JPE)
Time frame: 4 years
The Butterfly Test
Time frame: 4 years
Heart Rate Variability (HRV) milliseconds
Time frame: 4 years
The rate of HR recovery after the BCMT in beats per minute (BPM)
Time frame: 4 years
Pupillary reaction time
Time frame: 4 years
Pupil diameter change
Time frame: 4 years
Convergence rate millseconds
Time frame: 4 years
Time of Completion wioth the King Devick (KD) pre and post-exercise
Time frame: 4 years
Number of errors on the King Devick (KD) pre and post-exercise
Time frame: 4 years
Run/roll/aim task
Time frame: 4 years
Suitability of Exercise RESET
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Leddy, MD principal investigator
University at Buffalo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Brain Concussion, run by State University of New York at Buffalo at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Post Concussive Symptoms (PPCS) (Yes/No) (time frame: 28 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.