Clinical trial NCT04586179: A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
Official title: A Physiological and Clinical Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Concussion, Mild
Sport Injury
Keywords: sport-related concussion
concussion therapy
aerobic exercise
exercise testing
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2020-10-14
Enrollment: 6
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Concussion Symptoms From Pre to Post Exercise
timeFrame: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
measure: Heart Rate
timeFrame: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
measure: Systolic and Diastolic Blood Pressure
timeFrame: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
measure: Exercise duration
timeFrame: Completed during the 1 study visit within 30 days following concussion
measure: Clinical recovery
timeFrame: Through study completion, approximately between 3 and 30 days following concussion
Secondary outcomes:
measure: Changes in vestibular ocular motor screening (VOMS) symptoms from pre-exercise to post-exercise
timeFrame: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Neuromuscular Research Laboratory-Warrior Human Performance Research Center
state: Pennsylvania
Study officials:
affiliation: UPMC Sports Medicine Concussion Program
name: Anthony P Kontos, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.