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| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
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Primary Aim: Compare physiological (e.g., heart rate) and clinical responses (e.g., symptom provocation) of adolescent and adult athletes (14-35 years of age) completing either a structured treadmill running or a dynamic aerobic exertion protocol during the subacute phase of sport-related concussion recovery (3-30 days after injury).
Secondary Aim: Examine potential effects of clinically-relevant factors that influence symptom responses to controlled aerobic exertion, such as age, physical activity patterns, motion sensitivities, psychological responses to injury, and sleep quality, among subjects completing controlled aerobic and dynamic exertion following sport-related concussion
Exercise testing is an emerging component of the clinical evaluation for sport-related concussion. Despite the growing empirical evidence to suggest that early activity following an initial rest period after injury is beneficial to recovery, the effects of modifiable exercise prescription factors (e.g., exercise mode, duration, and intensity) is unknown. Given that dynamic exertion, which incorporates synchronized head-body movements, may contribute greater information processing demands for the functional pathways responsible for balance and equilibrium than treadmill running, may be more likely to provoke symptoms during exertion. Thus, physically active (>150 min/week of moderate-intensity physical activity) participants prior to a diagnosed sport-related concussion will be randomly assigned to complete either an aerobic or dynamic exercise task at 1 study visit following injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic (treadmill) Exercise | Active Comparator | Participants will wear a heart rate monitor and complete the Buffalo Concussion Treadmill Test |
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| Dynamic Exercise | Experimental | Participants will wear a heart rate monitor and complete a dynamic exertion assessment that incorporates directional changes that incrementally increases in exercise intensity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic (treadmill) Exercise | Other | Individuals begin walking at 5.8 km/hr. (3.6 mph) at a 0.0% incline (5.1 km/hr. [3.2 mph] if below 5' 10" tall), the treadmill incline is increased 1 degree each minute for the first 15 minutes, then speed increased 0.64 km/hr. (0.4 mph) each minute thereafter. Exercise will be terminated if participant a) attains 90 percent of predicted heart rate reserve (HRR=.90*[{208-(.7*age)}-resting HR]), or b) reports a symptom worsening of 3 or points (0-10 scale) for headache, dizziness, or nausea, d) a rapid progression of complaints with continued exercise, or e) a rating of perceived exertion (RPE) greater than 18.5. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Concussion Symptoms From Pre to Post Exercise | Concussion symptoms will be measured with the Post-concussion Symptom Scale (PCSS), a patient-report survey of 22 concussion-associated symptoms on a 0-6 Likert scale (0 'none' to 6 'severe'). Number of reported symptoms (range: 0- 22) and total symptom severity (range: 0-132) whereby greater scores indicate worse symptom burden will be examined. The survey takes approximately 5 minutes to complete | At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation |
| Heart Rate | Actual and percent of age-estimated heart rate, measured in beats per minute , will be recorded prior to (approximately 5 min), during, and following (approximately 5 min) exercise via a noninvasive heart rate monitor. Heart rate at rest, exercise cessation, and their difference (maximum heart rate - resting heart rate) will be recorded. | At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation |
| Systolic and Diastolic Blood Pressure | Systolic and diastolic blood pressure, measured in mmHg with a non-invasive blood pressure cuff, will be recorded prior to and following exercise intervention. | At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation |
| Exercise duration | Exercise duration, the time interval between exercise initiation and cessation, will be recorded in seconds (range: 0-900) | Completed during the 1 study visit within 30 days following concussion |
| Clinical recovery | Duration of clinical recovery, measured in days, is the interval between injury onset until medical clearance to resume unrestricted sport participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vestibular ocular motor screening (VOMS) symptoms from pre-exercise to post-exercise | The vestibular/ocular motor screening (VOMS) tool is a brief (approximately 5 minutes) patient-reported assessment to screen for vestibular and ocular motor impairments after concussion. Participants report on a 0-10 Likert scale (0 'none' to 10 'severe') prior to and following each of the 7 VOMS sub-tests: smooth pursuits, horizontal saccades, vertical saccades, near-point of convergence, horizontal vestibular-ocular reflex, vertical vestibular-ocular reflex, visual motion sensitivity; and near point of convergence (NPC) distance. Symptoms will be totaled across all symptoms and sub-tests (maximum=240) whereby greater scores indicate worse symptom burden. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony P Kontos, PhD | UPMC Sports Medicine Concussion Program | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromuscular Research Laboratory-Warrior Human Performance Research Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30439726 | Background | Orr R, Bogg T, Fyffe A, Lam LT, Browne GJ. Graded Exercise Testing Predicts Recovery Trajectory of Concussion in Children and Adolescents. Clin J Sport Med. 2021 Jan;31(1):23-30. doi: 10.1097/JSM.0000000000000683. | |
| 28570092 | Background | Lal A, Kolakowsky-Hayner SA, Ghajar J, Balamane M. The Effect of Physical Exercise After a Concussion: A Systematic Review and Meta-analysis. Am J Sports Med. 2018 Mar;46(3):743-752. doi: 10.1177/0363546517706137. Epub 2017 Jun 1. |
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Sharing Statement: Deidentified Individual participant data that underlie the current protocol will be available. Study protocol, statistical analysis plan, informed consent form, and individual participant data will be available (including data dictionary) beginning 12 months following completion of study and ending 36 months afterward. Investigators who provide a methodologically sound proposal to achieve individual participant data for meta-analyses should be directed to: https://www.nmrl.pitt.edu/ OR https://www.orthonet.pitt.edu/research/research-centers-and-labs/concussion-research-laboratory
12 months following completion of study and ending 36 months afterward
Investigators who provide a methodologically sound proposal to achieve individual participant data for meta-analyses
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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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Care provider will not be aware of group assignment; participant will be aware of intervention assessment
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| Dynamic (Agility) Exercise | Other | Participants will begin in a center circle with equidistant cones 2.5 meters away. After the administrator presents a card, the participant touches a corresponding cone and returns to the starting position. Cards will be presented in increasing frequency in synchrony with a metronome application until exercise termination criteria are identified. Exercise will be terminated if participant a) attains 90 percent of predicted heart rate reserve (HRR=.90*[{208-(.7*age)}-resting HR]), or b) reports a symptom worsening of 3 or points (0-10 scale) for headache, dizziness, or nausea, d) a rapid progression of complaints with continued exercise, or e) a rating of perceived exertion greater than 18.5. |
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| Through study completion, approximately between 3 and 30 days following concussion |
| At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation |
| 31432081 | Background | Lumba-Brown A, Teramoto M, Bloom OJ, Brody D, Chesnutt J, Clugston JR, Collins M, Gioia G, Kontos A, Lal A, Sills A, Ghajar J. Concussion Guidelines Step 2: Evidence for Subtype Classification. Neurosurgery. 2020 Jan 1;86(1):2-13. doi: 10.1093/neuros/nyz332. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |