Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

NCT06263179 | Completed

• 2 other identifiers: STUDY00007706UL1TR001412
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (1)

• Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed.

  Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting exercise sessions completed.

  Up to 6 weeks

Secondary Outcomes (8)

• Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale

  Baseline, week 1, week 2, week 3, week 4, week 5, week 6

• Change in Patient Health Questionnaire-9 (PHQ-9)

  Baseline, up to week 6

• Change in Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, up to week 6

• Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)

  Baseline

• Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)

  Baseline, up to week 6

Other Outcomes (1)

• Rate of adverse Events as assessed by questioning the participant

  Up to week 6

Study Arms (1)

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.

Behavioral: Target Heartrate Aerobic Exercise

Interventions

Target Heartrate Aerobic Exercise BEHAVIORAL

Exercise program

Target Heartrate Aerobic Exercise (THRAE)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UBMD Orthopaedics and Sports Medicine

Williamsville, New York, 14221, United States

Location

Related Publications (7)

• 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.

  PMID: 30829642 BACKGROUND

• 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.

  PMID: 30715132 BACKGROUND

• 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.

  PMID: 34600629 BACKGROUND

• 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.

  PMID: 28986414 BACKGROUND

• 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.

  PMID: 18183509 BACKGROUND

• 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.

  PMID: 36649295 BACKGROUND

• 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.

  PMID: 40504846 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Jacob McPherson

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Target Heartrate Aerobic Exercise

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 16, 2024
• Study Start: July 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)