Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

NCT ID: NCT06263179

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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

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Concussion, Brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Target Heartrate Aerobic Exercise
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Target Heartrate Aerobic Exercise (THRAE)

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.

Group Type EXPERIMENTAL

Target Heartrate Aerobic Exercise

Intervention Type BEHAVIORAL

Exercise program

Interventions

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Target Heartrate Aerobic Exercise

Exercise program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 18-40
* Received a concussion at work and are engaged with the workers compensation program
* Within 3 weeks of concussive injury

Exclusion Criteria

* 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
* Report of injury mechanism occurring due to physical assault
* Unwillingness to perform intervention
* Limited English proficiency.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Jacob I. McPherson

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacob McPherson

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Locations

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UBMD Orthopaedics and Sports Medicine

Williamsville, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30829642 (View on PubMed)

Leddy 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.

Reference Type BACKGROUND
PMID: 30715132 (View on PubMed)

Leddy 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.

Reference Type BACKGROUND
PMID: 34600629 (View on PubMed)

de 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.

Reference Type BACKGROUND
PMID: 28986414 (View on PubMed)

Kristman 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.

Reference Type BACKGROUND
PMID: 18183509 (View on PubMed)

Smith 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.

Reference Type BACKGROUND
PMID: 36649295 (View on PubMed)

McPherson 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.

Reference Type DERIVED
PMID: 40504846 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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UL1TR001412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007706

Identifier Type: -

Identifier Source: org_study_id

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