Clinical trial NCT06276660: Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test
Official title: Comparing Symptom Provocation and Physiological Response Between Buffalo Concussion Treadmill Test (BCTT) Protocol and Modified Dynamic Exertion Test (mEXiT) Post Concussion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: mtbi
concussion
exertion therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit.

Detailed description: The Buffalo Concussion Treadmill Test is a well established test to determine intensity of exercise without significant symptoms provocation after sport related concussion.

This study will help determine if there is a difference in type of symptom response between the two tests, due to the dynamic changes of direction and strain on the vestibular system with the m-EXiT group. The investigators hypothesize there will not be a significant difference between the two groups in time to clearance to return to sport despite allowing for higher symptoms earlier on in recovery.

High school athletes who have been diagnosed with a sport-related concussion will be randomly assigned to complete either the BCTT or the modified dynamic EXiT test (m-EXiT). The BCTT group will follow the established protocol and exercise to an increase of 2/10 symptoms on a visual analog scale (VAS) or 17/20 on rate of perceived effort (RPE) scale. The m-EXiT test will complete a shortened version of the dynamic EXiT test, but will stop if participants have an increase of greater than 4 points of headache, dizziness or nausea or RPE of 17/20. Symptoms, heart rate, and RPE will be measured through out both tests as well as Post-Concussion Symptom Scale (PCSS), Vestibular Ocular Motors Screening (VOMS), blood pressure and heart rate will be administered before and after testing. The time (in days) to recovery, will also be recorded from the medical record to determine if there is a difference between the two groups.

The primary outcome for the study will be symptoms post test and heart rate. Secondary measures include: Post Concussion Symptom Score (PCSS), Clinical Profiles Screening (CP-Screen), Vestibular Ocular Motor Screening (VOMS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder - 7 (GAD-7) and blood pressure. These will be collected at one visit with participants, there are no follow-up or subsequent visits for this study.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with a sport related concussion within 14 days of injury
* 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 and determined the participant is capable of completing structured exercise.

Exclusion Criteria:

* Medically cleared from a previous concussion within the past 6 months
* More than 2 previous concussions (excluding current injury)
* History of brain surgery or traumatic brain injury (TBI) (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 or oculomotor condition
* Currently taking antidepressant, anticoagulant, beta-blocker, or anticonvulsant prescription medications
* Incapable of treadmill running up to 5.5 miles per hour (mph) and 4.5 mph for males and females respectively (self-reported).
* 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
* Currently have (or have had within the past 12 months) a bone, joint, or soft tissue (muscle, ligament, or tendon) problem that could be made worse by physical activity
* Been told by a doctor to only conduct physical activity under medical supervision.

Primary outcomes:
measure: Physiological response to dynamic or aerobic test (HEART RATE)
timeFrame: Visit 1 (baseline) (pre, during, and post testing) 90 minutes
measure: Physiological response to dynamic or aerobic test (SYMPTOM PROVOCATION)
timeFrame: Visit 1 (baseline) (pre and post testing) 90 minutes
Secondary outcomes:
measure: Post Concussion Symptom Scale
timeFrame: Visit 1 Baseline (60-90 minutes), participants only complete one visit
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Visit 1 Baseline (60-90 minutes), participants only complete one visit
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Visit 1 Baseline (60-90 minutes), participants only complete one visit
measure: Vestibular Ocular Motor Screening (VOMS)
timeFrame: Visit 1 Baseline (pre and post testing 60-90 minutes), participants only complete one visit
measure: Clinical Profiles Screening (CP-Screen)
timeFrame: Visit 1 Baseline (60-90 minutes), participants only complete one visit
measure: Blood Pressure
timeFrame: Visit 1 Baseline (pre and post testing 60-90 minutes), participants only complete one visit
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC/Univ of Pgh Sports Medicine Concussion Research Program
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Anthony P Kontos, PhD
role: PRINCIPAL_INVESTIGATOR
References: