Concussion, BrainNCT06263179
Feasibility of Aerobic Exercise for Recovery From Work-related Concussion
A study testing Target Heartrate Aerobic Exercise in people with Concussion, Brain, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Target Heartrate Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-40
- Received a concussion at work and are engaged with the workers compensation program
- Within 3 weeks of concussive injury
Who cannot join
- 3-point or less difference between current and pre-injury symptoms as measured by the Post-Concussion Symptom Inventory (PCSI)
- Moderate or severe TBI
- Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia > 24 hours
- Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation
- History of more than 3 diagnosed concussions
- Active substance abuse/dependence
Show all 9Show fewer
- Report of injury mechanism occurring due to physical assault
- Unwillingness to perform intervention
- Limited English proficiency.
Trial locations and contacts
1 site in 1 country.
United States1 site
UBMD Orthopaedics and Sports Medicine
Williamsville, New York, 14221
About this study
There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.
Read the detailed description
Participants who are diagnosed with a concussion and agree to participant in the study will complete a demographics form and other relevant questionnaires. They will then perform a graded exertion test (the Buffalo Concussion Treadmill Test [BCTT]) at the clinic, this takes approximately 15 minutes. Participants will then be prescribed the individualized THRAE based on the results from the BCTT and will be sent home with a commercial heart rate monitor. Participants will perform exercises at home on their free time 4-5 days per week. Participants will return to the clinic weekly to be re-examined by the study physician and obtain a new heart rate prescription for the first six weeks until clinical recovery or the intervention period ends (6-weeks).
- Conditions
- Concussion, Brain
- Being tested
- Target Heartrate Aerobic Exercise
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target Heartrate Aerobic ExerciseBehavioural
Exercise program
| Study group | Role | What they receive |
|---|---|---|
| Target Heartrate Aerobic Exercise (THRAE) | Experimental | Participants will be asked to complete the Buffalo Concussion Treadmill Test (BCTT), a safe graded exercise test that is used to identify concussion-related exertion intolerance. Participants will wear a heart rate (HR) monitor for the collection of continuous HR data. The test is stopped when a participant's symptoms increase subjectively by an intensity of 3 points or more from the pre-exercise value on a scale from 0-10, or they report being physically exhausted. Their HR at the time of test termination constitutes the HR threshold (HRt). An individualized THRAE program will be prescribed based on 80% of the HRt on the BCTT. Participants will be given a Polar HR monitor to wear while performing their THRAE prescription, which will be performed at home for 20 minutes, 4-5 days per week, for 6 weeks or until medically cleared from their concussion. Receives: Behavioral: Target Heartrate Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Adherence to Target Heartrate Aerobic Exercise (THRAE) Program as Measured by Counting the Number and Duration of Exercise Sessions Completed.
Subjective Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by a subjective report at each weekly meeting with the study's research assistant of exercise sessions performed. Participants were considered adherent if they complete 66% or more of their prescribed exercise sessions
Measured: Up to 6 weeks
Objective Adherence to Target Heartrate Aerobic Exercise (THRAE)
Objective Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting exercise sessions completed across participants using Polar app. Adherence was calculated by counting the number of exercise sessions logged within the system for all participants and dividing that value by the number days all subjects were eligible to exercise during their time in the study.
Measured: Up to 6 weeks.
Secondary outcomes (7)
Change in Post-concussive Symptom Burden as Measured by the Post-Concussion Symptom Scale
The Post-Concussion Symptom Scale (PCSS) is a validated 22-item self-report symptom questionnaire. Scores range from 0-132 with greater scores indicating increased symptom burden.
Measured: Baseline and final visit (6 weeks) or the visit the participant was deemed recovered, whichever occurred first.
Change in Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is used for rating the severity of depression among participants. Scores range from 0-27. Higher scores indicate increased severity of depression. To calculate change in Patient Health Questionnaire-9 (PHQ-9) scores, the mean final PHQ-9 score for all participants was subtracted from the mean initial score for all participants.
Measured: Baseline, up to week 6
Change in Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is used to measure the severity of anxiety among participants. Scores range from 0-21. Higher scores indicate increased severity of anxiety.
Measured: Baseline, up to week 6
Number of Participants With Positive Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)
This is a brief screening measure designed to identify individuals with probable post-traumatic stress disorder (PTSD). The measure begins with a trauma-exposure screening item; if no trauma exposure is endorsed, the score is 0. If trauma exposure is endorsed, 5 yes/no symptom items are completed. The total score is calculated by adding the number of "yes" responses yielding a range from 0 to 5. Lower scores indicate lower likelihood of PTSD; higher scores indicate greater likelihood of PTSD. Greater than 2 "yes" responses was considered a positive screen.
Measured: Baseline
Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)
The PROMIS Global Health-10 is a 10-item patient-reported measure of general health-related quality of life, including physical, mental, and social health. Raw scores are converted to a standardized T-score. T-scores have a mean of 50 and standard deviation of 10 in the reference population. Higher scores represent a better outcome, indicating better global physical or mental health; lower scores represent a worse outcome. Change in PROMIS-10 was calculated by subtracting the average score for all participants at Visit 1 from the average score for all participants at the final visit.
Measured: Baseline, up to week 6
Work Climate Questionnaire - 6-Item Version
The Work Climate Questionnaire - 6-Item Version is used for assessing participants' perceptions regarding the degree of autonomy supportiveness of their work managers or employers. Scores range of 6-42. Higher scores indicate a greater degree of perceived autonomy supportiveness.
Measured: Baseline
Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
This is a self-report measure assessing satisfaction and frustration of three basic psychological needs: autonomy, competence, and relatedness. Twenty-four items are rated from 1 to 5. Possible scores range from 24-120. Higher scores indicate greater psychological need satisfaction and less frustration. Change in this measure was calculated by subtracting the average score for all participants obtained at the final visit from the average score for all participants obtained at the initial study visit.
Measured: Baseline, up to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Jul 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Target Heartrate Aerobic Exercise
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Jacob I. McPherson, State University of New York at Buffalo
- Investigators
- Jacob McPherson, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263179
- Sponsor's protocol ID
- STUDY00007706
- Other IDs
- UL1TR001412
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2024
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma B, Nowrouzi-Kia B, Mollayeva T, Kontos P, Grigorovich A, Liss G, Gibson B, Mantis S, Lewko J, Colantonio A. Work-related traumatic brain injury: A brief report on workers perspective on job and health and safety training, supervision, and injury preventability. Work. 2019;62(2):319-325. doi: 10.3233/WOR-192866.
PubMed 30829642Leddy JJ, Haider MN, Ellis MJ, Mannix R, Darling SR, Freitas MS, Suffoletto HN, Leiter J, Cordingley DM, Willer B. Early Subthreshold Aerobic Exercise for Sport-Related Concussion: A Randomized Clinical Trial. JAMA Pediatr. 2019 Apr 1;173(4):319-325. doi: 10.1001/jamapediatrics.2018.4397.
PubMed 30715132Leddy JJ, Master CL, Mannix R, Wiebe DJ, Grady MF, Meehan WP, Storey EP, Vernau BT, Brown NJ, Hunt D, Mohammed F, Mallon A, Rownd K, Arbogast KB, Cunningham A, Haider MN, Mayer AR, Willer BS. Early targeted heart rate aerobic exercise versus placebo stretching for sport-related concussion in adolescents: a randomised controlled trial. Lancet Child Adolesc Health. 2021 Nov;5(11):792-799. doi: 10.1016/S2352-4642(21)00267-4. Epub 2021 Oct 1.
PubMed 34600629de Koning ME, Scheenen ME, van der Horn HJ, Timmerman ME, Hageman G, Roks G, Spikman JM, van der Naalt J. Prediction of work resumption and sustainability up to 1 year after mild traumatic brain injury. Neurology. 2017 Oct 31;89(18):1908-1914. doi: 10.1212/WNL.0000000000004604. Epub 2017 Oct 6.
PubMed 28986414Kristman VL, Cote P, Van Eerd D, Vidmar M, Rezai M, Hogg-Johnson S, Wennberg RA, Cassidy JD. Prevalence of lost-time claims for mild traumatic brain injury in the working population: improving estimates using workers compensation databases. Brain Inj. 2008 Jan;22(1):51-9. doi: 10.1080/02699050701849991.
PubMed 18183509Smith CK, Wuellner S, Marcum J. Racial and ethnic disparities in workers' compensation claims rates. PLoS One. 2023 Jan 17;18(1):e0280307. doi: 10.1371/journal.pone.0280307. eCollection 2023.
PubMed 36649295McPherson JI, Miecznikowski JC, Chizuk H, Sparks P, Leddy JJ, Haider MN, Stavisky CJ. Feasibility trial protocol assessing the use of aerobic exercise to promote recovery from work-related concussion. PLoS One. 2025 Jun 12;20(6):e0325701. doi: 10.1371/journal.pone.0325701. eCollection 2025.
PubMed 40504846
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Aerobic Exercise for Recovery From Work-related Concussion
- ClinicalTrials.gov ID
- NCT06263179
- Acronym / sponsor ID
- STUDY00007706
- Conditions
- Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.
Detailed description
Participants who are diagnosed with a concussion and agree to participant in the study will complete a demographics form and other relevant questionnaires. They will then perform a graded exertion test (the Buffalo Concussion Treadmill Test [BCTT]) at the clinic, this takes approximately 15 minutes. Participants will then be prescribed the individualized THRAE based on the results from the BCTT and will be sent home with a commercial heart rate monitor. Participants will perform exercises at home on their free time 4-5 days per week. Participants will return to the clinic weekly to be re-examined by the study physician and obtain a new heart rate prescription for the first six weeks until clinical recovery or the intervention period ends (6-weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Target Heartrate Aerobic Exercise
| Arm | Type | Receives |
|---|---|---|
| Target Heartrate Aerobic Exercise (THRAE) | Experimental | Behavioral: Target Heartrate Aerobic ExerciseParticipants will be asked to complete the Buffalo Concussion Treadmill Test (BCTT), a safe graded exercise test that is used to identify concussion-related exertion intolerance. Participants will wear a heart rate (HR) monitor for the collection of continuous HR data. The test is stopped when a participant's symptoms increase subjectively by an intensity of 3 points or more from the pre-exercise value on a scale from 0-10, or they report being physically exhausted. Their HR at the time of test termination constitutes the HR threshold (HRt). An individualized THRAE program will be prescribed based on 80% of the HRt on the BCTT. Participants will be given a Polar HR monitor to wear while performing their THRAE prescription, which will be performed at home for 20 minutes, 4-5 days per week, for 6 weeks or until medically cleared from their concussion. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-40
- Received a concussion at work and are engaged with the workers compensation program
- Within 3 weeks of concussive injury
Key exclusion criteria (9 listed)
- 3-point or less difference between current and pre-injury symptoms as measured by the Post-Concussion Symptom Inventory (PCSI)
- Moderate or severe TBI
- Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia > 24 hours
- Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation
- History of more than 3 diagnosed concussions
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 |
|---|---|---|
| Target Heartrate Aerobic ExerciseExercise program | Behavioural | Target Heartrate Aerobic Exercise (THRAE) |
Primary outcome
Subjective Adherence to Target Heartrate Aerobic Exercise (THRAE) Program as Measured by Counting the Number and Duration of Exercise Sessions Completed.
Time frame: Up to 6 weeks
Subjective Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by a subjective report at each weekly meeting with the study's research assistant of exercise sessions performed. Participants were considered adherent if they complete 66% or more of their prescribed exercise sessions
Objective Adherence to Target Heartrate Aerobic Exercise (THRAE)
Time frame: Up to 6 weeks.
Objective Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting exercise sessions completed across participants using Polar app. Adherence was calculated by counting the number of exercise sessions logged within the system for all participants and dividing that value by the number days all subjects were eligible to exercise during their time in the study.
7 secondary outcomes
Change in Post-concussive Symptom Burden as Measured by the Post-Concussion Symptom Scale
Time frame: Baseline and final visit (6 weeks) or the visit the participant was deemed recovered, whichever occurred first.
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, up to week 6
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, up to week 6
Number of Participants With Positive Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)
Time frame: Baseline
Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)
Time frame: Baseline, up to week 6
Work Climate Questionnaire - 6-Item Version
Time frame: Baseline
Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
Time frame: Baseline, up to week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30829642Sharma B, Nowrouzi-Kia B, Mollayeva T, Kontos P, Grigorovich A, Liss G, Gibson B, Mantis S, Lewko J, Colantonio A. Work-related traumatic brain injury: A brief report on workers perspective on job and health and safety training, supervision, and injury preventability. Work. 2019;62(2):319-325. doi: 10.3233/WOR-192866.
- Background: PubMed 30715132Leddy JJ, Haider MN, Ellis MJ, Mannix R, Darling SR, Freitas MS, Suffoletto HN, Leiter J, Cordingley DM, Willer B. Early Subthreshold Aerobic Exercise for Sport-Related Concussion: A Randomized Clinical Trial. JAMA Pediatr. 2019 Apr 1;173(4):319-325. doi: 10.1001/jamapediatrics.2018.4397.
- Background: PubMed 34600629Leddy JJ, Master CL, Mannix R, Wiebe DJ, Grady MF, Meehan WP, Storey EP, Vernau BT, Brown NJ, Hunt D, Mohammed F, Mallon A, Rownd K, Arbogast KB, Cunningham A, Haider MN, Mayer AR, Willer BS. Early targeted heart rate aerobic exercise versus placebo stretching for sport-related concussion in adolescents: a randomised controlled trial. Lancet Child Adolesc Health. 2021 Nov;5(11):792-799. doi: 10.1016/S2352-4642(21)00267-4. Epub 2021 Oct 1.
- Background: PubMed 28986414de Koning ME, Scheenen ME, van der Horn HJ, Timmerman ME, Hageman G, Roks G, Spikman JM, van der Naalt J. Prediction of work resumption and sustainability up to 1 year after mild traumatic brain injury. Neurology. 2017 Oct 31;89(18):1908-1914. doi: 10.1212/WNL.0000000000004604. Epub 2017 Oct 6.
- Background: PubMed 18183509Kristman VL, Cote P, Van Eerd D, Vidmar M, Rezai M, Hogg-Johnson S, Wennberg RA, Cassidy JD. Prevalence of lost-time claims for mild traumatic brain injury in the working population: improving estimates using workers compensation databases. Brain Inj. 2008 Jan;22(1):51-9. doi: 10.1080/02699050701849991.
- Background: PubMed 36649295Smith CK, Wuellner S, Marcum J. Racial and ethnic disparities in workers' compensation claims rates. PLoS One. 2023 Jan 17;18(1):e0280307. doi: 10.1371/journal.pone.0280307. eCollection 2023.
- Derived from this study: PubMed 40504846McPherson JI, Miecznikowski JC, Chizuk H, Sparks P, Leddy JJ, Haider MN, Stavisky CJ. Feasibility trial protocol assessing the use of aerobic exercise to promote recovery from work-related concussion. PLoS One. 2025 Jun 12;20(6):e0325701. doi: 10.1371/journal.pone.0325701. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Jacob McPherson principal investigator
SUNY Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target Heartrate Aerobic Exercise in people with Concussion, Brain, run by State University of New York at Buffalo at 1 site 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 3 inclusion and 9 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 28 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 1 site 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?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subjective Adherence to Target Heartrate Aerobic Exercise (THRAE) Program as Measured by Counting the Number and Duration of Exercise Sessions Completed. (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263179, which also lists 7 linked publications.
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 28 Oct 2026.