A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
NCT ID: NCT04586179
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2020-09-27
2021-06-03
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Aerobic (treadmill) Exercise
Participants will wear a heart rate monitor and complete the Buffalo Concussion Treadmill Test
Aerobic (treadmill) Exercise
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.
Dynamic Exercise
Participants will wear a heart rate monitor and complete a dynamic exertion assessment that incorporates directional changes that incrementally increases in exercise intensity
Dynamic (Agility) Exercise
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.
Interventions
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Aerobic (treadmill) Exercise
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.
Dynamic (Agility) Exercise
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
14 Years
35 Years
ALL
No
Sponsors
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University of Pittsburgh Medical Center
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Anthony P. Kontos, Ph.D.
Associate Professor
Principal Investigators
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Anthony P Kontos, PhD
Role: STUDY_DIRECTOR
UPMC Sports Medicine Concussion Program
Locations
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Neuromuscular Research Laboratory-Warrior Human Performance Research Center
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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STUDY20010091
Identifier Type: -
Identifier Source: org_study_id
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