Sport-related Concussion
Conditions
Keywords
concussion, aerobic exercise, sub-acute
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.
Interventions
BEHAVIORALExercise
HR-controlled treadmill walking
Sponsors
Tallahassee Orthopedic Clinic
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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)
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Recovery | 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. | Clinical recovery is defined as the duration from the time of injury to the time a patient has received full clearance without restriction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure (SBP & DBP) | SBP & DBP will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post treatment. | SBP & DBP will be recorded with an automated auscultatory BP system |
| Ocular Dysfunction | The King-Devick (K-D) will be administered before and within 5 minutes after the acute 20 minute treatment | Improvements in ocular dysfunction will be defined as a decrease in errors or reading time |
| Vestibular Dysfunction | The Vestibular / Ocular Motor Screening (VOMS) will be administered before and within 5 minutes after the acute 20 minute treatment | Improvements in vestibular dysfunction will be defined as a decrease in symptom provocation or pretest symptom reporting |
| Heart rate variability (HRV) | HRV will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post treatment. | The RR Interval will be extracted from the heart rate monitoring system. |
| Concussion Symptoms | Symptoms will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post treatment. | All 22 symptoms from the Post-concussion symptom scale (PCSS) as measured on a Likert scale from 0 (not present) to 6 (severe) |
| Exercise Bout Completion Rates | Completion will be determined and recorded at the end of the acute 20 minute treatment. | The rate of completion will be defined as the ability for the participant to finish the treatment without early termination. |
| Incidence of Persistent Postconcussion symptoms >28 days | The duration in days will be calculated from the day injury to the day full clearance up to 1 year. | Persistent symptoms duration will be categorized as either ≤28 days or \> 28 days. |
| Rating of Perceived Exertion (RPE) | RPE will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post treatment. | Borg's CR-15 will be utilized to quantifying perceived intensity of exercise |
Countries
United States
Outcome results
None listed