Clinical trial NCT05013307: Clinical Assessment of Sports Exertion
Official title: Baylor Scott and White Sports Concussion Program Clinical Assessment of Sports Exertion Research Proposal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Return to Sport
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Sports Academy
First posted: 2021-08-19
Enrollment: 125
Sex: ALL
Minimum age (years): 10
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The Clinical Assessment for Sports Exertion (CASE) addresses the physical performance of athletes by quantifying physiological and symptomatic responses to dynamic exertion. The CASE is highly sport-specific as it tests multiple body positions that mimic requirements typical of individual and contact sports activities including soccer, gymnastics, cheerleading, swimming, and basketball. It was developed by clinicians at the Baylor Scott and White Sports Concussion Program in an effort to identify specific system impairments in athletes who were unable to successfully demonstrate readiness for return to play protocols. Like the other published forms of concussion exertion testing described above, the CASE is a provocative exercise test that may also prove to be useful in making informed return-to-play decisions based upon the athlete's symptomatology.


Eligibility criteria: Inclusion Criteria:

* 10-22 years of age who have participated in organized sport activities within the past 12 months
* Diagnosed with a concussion according to international concussion in sport group criteria
* Asymptomatic at rest and must be cleared from return-to-play by a qualified healthcare professional no later than 30 days following clearance

Exclusion Criteria:

* Orthopedic or neurologic, or other limitations
* History of seizures
* Previous or current diagnoses for cardiopulmonary conditions
* Medical diagnosis of diabetes and/or currently on medications for diabetes (e.g., insulin)
* Uncontrolled asthma
* Pregnancy
* Currently experiencing symptoms of COVID-19 or \< 7 days since last symptoms
* History of moderate or severe traumatic brain injury defined as a brain injury with an associated Glasgow Coma Scale score of 12 or less
* Symptom score \>1 point on initial PCSS intake
* A current diagnosis of and treatment with medication for attention-deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions
* Limited English proficiency
* Currently taking prescription medication for concussion related impairments
* Anticoagulant or antiplatelet use
* History of a medical condition that mimics the signs and symptoms of prolonged concussion symptoms (eg, history of chronic headaches, active migraines, cardiovascular conditions)

Primary outcomes:
measure: Heart rate (bpm)
timeFrame: through study completion, an average of 1.5 hours
measure: Blood pressure (mmHg)
timeFrame: through study completion, an average of 1.5 hours
measure: Oxygen Saturation (%)
timeFrame: through study completion, an average of 1.5 hours
measure: Rate of Perceived Exertion (Borg 6-20)
timeFrame: through study completion, an average of 1.5 hours
measure: Self-rated lightheadedness (0-6)
timeFrame: through study completion, an average of 1.5 hours
measure: Self-rated dyspnea (Modified Borg 0-10)
timeFrame: through study completion, an average of 1.5 hours
measure: Heart rate reserve (peak-rest), beats/min-1
timeFrame: through study completion, an average of 1.5 hours
Secondary outcomes:
measure: Modified Post-Concussion Symptom Scale (PCSS) (0-6)
timeFrame: through study completion, an average of 1.5 hours
Other outcomes:
Locations:
city: Frisco
country: United States
facility: Baylor Scott and White Sports Therapy and Research
state: Texas
Study officials:
References: