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Enrolling by Invitation

NCT Number: NCT05013307

Clinical Assessment of Sports Exertion

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.

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Key information

Conditions

Return to Sport

Age range

10 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott and White Sports Therapy and Research

Frisco, Texas, 75034, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CASE

Other

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.

Primary outcomes

  1. Heart rate (bpm)

    Time frame: through study completion, an average of 1.5 hours

    Using pulse oximeter placed on index finger heart rate will be recorded.

  2. Blood pressure (mmHg)

    Time frame: through study completion, an average of 1.5 hours

    Using a manual cuff and auscultation method diastolic and systolic scores will be recorded.

  3. Oxygen Saturation (%)

    Time frame: through study completion, an average of 1.5 hours

    Using pulse oximeter placed on index finger oxygen saturation will be recorded.

  4. Rate of Perceived Exertion (Borg 6-20)

    Time frame: through study completion, an average of 1.5 hours

    Using Borg Scale, self report measure of exertion will be recorded. A higher number indicates higher exertion.

  5. Self-rated lightheadedness (0-6)

    Time frame: through study completion, an average of 1.5 hours

    On a scale of 0-6, a self report measure of lightheadedness will be recorded. A higher number indicates worse lightheadedness.

  6. Self-rated dyspnea (Modified Borg 0-10)

    Time frame: through study completion, an average of 1.5 hours

    Using Borg scale, self report measure of dyspnea will be recorded. A higher number indicates worse dyspnea.

  7. Heart rate reserve (peak-rest), beats/min-1

    Time frame: through study completion, an average of 1.5 hours

    Using metabolic cart, heart rate reserve will be recorded via Garmin heart rate strap.

Secondary outcomes

  1. Modified Post-Concussion Symptom Scale (PCSS) (0-6)

    Time frame: through study completion, an average of 1.5 hours

    Using modified PCSS, self report measure of symptoms will be recorded. A high number indicates worse symptoms.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Sports Academy

Registry information

Official study title

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

Acronym: CASE

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2021
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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