Clinical trial NCT06263179: Feasibility of Aerobic Exercise for Recovery From Work-related Concussion
Official title: Feasibility of Aerobic Exercise for Recovery From Work-related Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-02-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Target Heartrate Aerobic Exercise
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed.
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale
timeFrame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, up to week 6
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, up to week 6
measure: Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)
timeFrame: Baseline
measure: Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)
timeFrame: Baseline, up to week 6
measure: Work Climate Questionnaire - 6-Item Version
timeFrame: Baseline
measure: Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame: Baseline, up to week 6
measure: Time to return to work measured in days
timeFrame: Up to week 6
Other outcomes:
measure: Rate of adverse Events as assessed by questioning the participant
timeFrame: Up to week 6
Locations:
city: Williamsville
country: United States
facility: UBMD Orthopaedics and Sports Medicine
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Jacob McPherson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.