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Clinical Assessment of Sports Exertion

Baylor Scott and White Sports Concussion Program Clinical Assessment of Sports Exertion Research Proposal

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05013307
Acronym
CASE
Enrollment
125
Registered
2021-08-19
Start date
2021-08-07
Completion date
2027-12-31
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Return to Sport

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.

Interventions

OTHERCASE

The Clinical Assessment for Sports Exertion (CASE) addresses the physical performance of athletes by quantifying physiological and symptomatic responses to dynamic exertion. 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.

Sponsors

Baylor Research Institute
Lead SponsorOTHER
Sports Academy
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 22 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Heart rate (bpm)through study completion, an average of 1.5 hoursUsing pulse oximeter placed on index finger heart rate will be recorded.
Blood pressure (mmHg)through study completion, an average of 1.5 hoursUsing a manual cuff and auscultation method diastolic and systolic scores will be recorded.
Oxygen Saturation (%)through study completion, an average of 1.5 hoursUsing pulse oximeter placed on index finger oxygen saturation will be recorded.
Rate of Perceived Exertion (Borg 6-20)through study completion, an average of 1.5 hoursUsing Borg Scale, self report measure of exertion will be recorded. A higher number indicates higher exertion.
Self-rated lightheadedness (0-6)through study completion, an average of 1.5 hoursOn a scale of 0-6, a self report measure of lightheadedness will be recorded. A higher number indicates worse lightheadedness.
Self-rated dyspnea (Modified Borg 0-10)through study completion, an average of 1.5 hoursUsing Borg scale, self report measure of dyspnea will be recorded. A higher number indicates worse dyspnea.
Heart rate reserve (peak-rest), beats/min-1through study completion, an average of 1.5 hoursUsing metabolic cart, heart rate reserve will be recorded via Garmin heart rate strap.

Secondary

MeasureTime frameDescription
Modified Post-Concussion Symptom Scale (PCSS) (0-6)through study completion, an average of 1.5 hoursUsing modified PCSS, self report measure of symptoms will be recorded. A high number indicates worse symptoms.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026