Clinical trial NCT03575455: Sub-acute Exercise Following Sport-Related Concussion
Official title: The Short- And Long-Term Effects Of Submaximal Aerobic Exercise On Recovery Following Sport-Related Concussion In High School Student-Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport-related Concussion
Keywords: concussion
aerobic exercise
sub-acute
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Tallahassee Orthopedic Clinic
First posted: 2018-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized block design using age and sex to randomize into 3 injured groups (40%, 60%, CON) and matching for 3 healthy groups (40%, 60%, CON)
Primary purpose: TREATMENT

Brief summary: Determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase of recovery following sport-related concussion.

Detailed description: The main objective of the proposed study is to determine is exercise during the first 3-7 days following a sport-related concussion can help improve the systemic neurological dysfunction following a concussion while examining the safety and efficacy of a 20-minute, low- to moderate-intensity (40-60% of HRMAX) controlled treadmill aerobic exercise as a therapeutic modality to improve cardiovascular, psychological, vestibulo-ocular, autonomic, and cognitive function.

Eligibility criteria: Inclusion Criteria (concussed):

* high school student-athlete
* suffered a diagnosed concussion
* evaluated between Day 3 and Day 7 since injury

Inclusion Criteria (healthy):

* high school student-athlete
* no diagnosed concussion within the last year
* matched with concussion participant for age and gender

Exclusion Criteria:

* physical limitation prohibiting treadmill walking
* reports dizziness or lightheadedness
* presents with any contraindication for exercise participation as defined by American College of Cardiology (ACC), American Heart Association (AHA), or American College of Sports Medicine (ACSM) guidelines.

Primary outcomes:
measure: Clinical Recovery
timeFrame: The number of days from injury to full medical clearance up to 365 days. 80% of adolescent athletes fully recover in less than 28 days.
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: HRV will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
measure: Blood Pressure (SBP & DBP)
timeFrame: SBP & DBP will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
measure: Ocular Dysfunction
timeFrame: The King-Devick (K-D) will be administered before and within 5 minutes after the acute 20 minute "treatment"
measure: Vestibular Dysfunction
timeFrame: The Vestibular / Ocular Motor Screening (VOMS) will be administered before and within 5 minutes after the acute 20 minute "treatment"
measure: Rating of Perceived Exertion (RPE)
timeFrame: RPE will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
measure: Concussion Symptoms
timeFrame: Symptoms will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
measure: Exercise Bout Completion Rates
timeFrame: Completion will be determined and recorded at the end of the acute 20 minute treatment.
measure: Incidence of Persistent Postconcussion symptoms >28 days
timeFrame: The duration in days will be calculated from the day injury to the day full clearance up to 1 year.
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic
state: Florida
Study officials:
References:
citation: Worts PR, Mason JR, Burkhart SO, Sanchez-Gonzalez MA, Kim JS. The acute, systemic effects of aerobic exercise in recently concussed adolescent student-athletes: preliminary findings. Eur J Appl Physiol. 2022 Jun;122(6):1441-1457. doi: 10.1007/s00421-022-04932-4. Epub 2022 Mar 18.