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| Name | Class |
|---|---|
| Tallahassee Orthopedic Clinic | OTHER |
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Determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase of recovery following sport-related concussion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | 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. |
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| Seated Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | HR-controlled treadmill walking |
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| 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. |
| 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) |
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Inclusion Criteria (concussed):
Inclusion Criteria (healthy):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallahassee Orthopedic Clinic | Tallahassee | Florida | 32308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35303160 | Derived | 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. |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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)
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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. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |