Concussion, Mild Clinical Trial
Official title:
A Physiological and Clinical Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
Verified date | May 2022 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 6 |
Est. completion date | June 3, 2021 |
Est. primary completion date | June 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 35 Years |
Eligibility | Inclusion Criteria: - Ages 14-35 - Prior to injury, participant fulfilled ACSM's guidelines for regular aerobic activity (30 minutes of moderate-intensity exercise 5 days per week or 20 minutes of vigorous exercise 3 days per week) prior to injury. - Diagnosed with a sport related concussion within 14 days of injury in the window of 3-30 days prior to completing the first study visit, and also being a single episode. - Participants referred to exertion therapy after a trained clinician from University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program has interpreted neurocognitive, vestibular, and clinical interview outcomes Exclusion Criteria: - History of brain surgery or traumatic brain injury(based on Glasgow Coma Scale of <13) - History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations) - Current history of pre-existing vestibular disorder [benign paroxysmal positional vertigo (BPPV), labyrinthitis or vestibular neuritis] - Previous diagnosis of ocular motor condition (Ocular motor apraxia)Currently taking anticoagulant, beta-blockers, and anticonvulsant prescription medication - Diagnosed with a cardiac, peripheral, or cerebrovascular disease (type 1 or 2 diabetes, or renal disease. - Experienced chest pain or shortness of breath while at rest or with mild exertion. - Lose balance because of dizziness or have lost consciousness (aside from concussion) from exertion - Diagnosed with or taking medication for a chronic medical condition - Currently have a mental or physical impairment exacerbated by physical activity, leading to the inability to complete 30 minutes of moderate to vigorous exercise - Been told by a doctor to only conduct physical activity under medical supervision. |
Country | Name | City | State |
---|---|---|---|
United States | Neuromuscular Research Laboratory-Warrior Human Performance Research Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | University of Pittsburgh Medical Center |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Clinical recovery | Duration of clinical recovery, measured in days, is the interval between injury onset until medical clearance to resume unrestricted sport participation. | Through study completion, approximately between 3 and 30 days following concussion | |
Secondary | 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. | At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05849064 -
Concussion Treatment in Older Adults
|
N/A | |
Not yet recruiting |
NCT05943561 -
Biomarkers in Concussion
|
||
Completed |
NCT03236389 -
Brain Dynamics in Response to Jugular Vein Compression
|
N/A | |
Completed |
NCT02721537 -
Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes
|
N/A | |
Completed |
NCT01832714 -
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
|
||
Completed |
NCT04560400 -
Reverse King-Devick Test and History of Multiple Concussions
|
N/A | |
Completed |
NCT03678077 -
Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
|
||
Recruiting |
NCT05262361 -
Persistent Post-Concussion Symptoms With Convergence Insufficiency
|
N/A | |
Recruiting |
NCT05105802 -
Mindfulness-Based Intervention for Mild Traumatic Brain Injury
|
N/A | |
Terminated |
NCT03123822 -
Spectacles Lens in Concussed Kids
|
N/A | |
Completed |
NCT04641832 -
The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health
|
N/A | |
Completed |
NCT04074486 -
Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
|
||
Withdrawn |
NCT04578743 -
Exercise as Concussion Therapy Trial- 2
|
Phase 2 | |
Completed |
NCT03170856 -
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
|
N/A | |
Completed |
NCT03671083 -
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
|
||
Completed |
NCT05069948 -
Delivery of Digital Cognitive Behavioural Therapy Following Concussion
|
N/A | |
Recruiting |
NCT03889483 -
Neurophysiological Measurements Using the NeuroCatchâ„¢ Platform in Pediatric Concussion
|
N/A | |
Withdrawn |
NCT02959294 -
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
|
Early Phase 1 | |
Recruiting |
NCT06093295 -
Non-invasive Brain Stimulation and Injury Risk Biomechanics
|
N/A | |
Completed |
NCT02280304 -
Meditation in Veterans With PTSD and Mild TBI
|
N/A |