Sub-acute Exercise Following Sport-Related Concussion

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

Detailed Description
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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.

Official Title
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The Short- And Long-Term Effects Of Submaximal Aerobic Exercise On Recovery Following Sport-Related Concussion In High School Student-Athletes

Conditions
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Sport-related Concussion

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Concussed participants will participate in a single 20' bout of treadmill walking at either 40% or 60% of the age-predicted HRmax. Healthy participants will participate in a single 20' bout of treadmill walking at either 40% or 60% of the age-predicted HRmax. | Behavioral: Exercise<br>* HR-controlled treadmill walking<br>* Other names: Aerobic exercise;|
| No Intervention: Seated Control<br>Concussed participants will participate in a single 20' treatment session of seated rest. Healthy participants will participate in a single 20' treatment session of seated rest. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Recovery | Clinical recovery is defined as the duration from the time of injury to the time a patient has received full clearance without restriction. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (HRV) | The RR Interval will be extracted from the heart rate monitoring system. | HRV will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post treatment. | 
| Blood Pressure (SBP & DBP) | SBP & DBP will be recorded with an automated auscultatory BP system | SBP & DBP will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post treatment. | 
| Ocular Dysfunction | Improvements in ocular dysfunction will be defined as a decrease in errors or reading time | The King-Devick (K-D) will be administered before and within 5 minutes after the acute 20 minute treatment | 
| Vestibular Dysfunction | Improvements in vestibular dysfunction will be defined as a decrease in symptom provocation or pretest symptom reporting | The Vestibular / Ocular Motor Screening (VOMS) will be administered before and within 5 minutes after the acute 20 minute treatment | 
| Rating of Perceived Exertion (RPE) | Borg's CR-15 will be utilized to quantifying perceived intensity of exercise | RPE will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post treatment. | 
| Concussion Symptoms | All 22 symptoms from the Post-concussion symptom scale (PCSS) as measured on a Likert scale from 0 (not present) to 6 (severe) | Symptoms will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post treatment. | 
| Exercise Bout Completion Rates | The rate of completion will be defined as the ability for the participant to finish the treatment without early termination. | Completion will be determined and recorded at the end of the acute 20 minute treatment. | 
| Incidence of Persistent Postconcussion symptoms >28 days | Persistent symptoms duration will be categorized as either ≤28 days or > 28 days. | The duration in days will be calculated from the day injury to the day full clearance up to 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concussion, aerobic exercise, sub-acute