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Enrolling by invitation NCT05013307

Clinical Assessment of Sports Exertion

No phase Interventional Return to Sport

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CASE.
Who it may be relevant to
Registry conditions: Return to Sport. Basic parameters: 10 years — 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other CASE
    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 outcome measures

  • Heart rate (bpm) [Time frame: through study completion, an average of 1.5 hours]
  • Blood pressure (mmHg) [Time frame: through study completion, an average of 1.5 hours]
  • Oxygen Saturation (%) [Time frame: through study completion, an average of 1.5 hours]
  • Rate of Perceived Exertion (Borg 6-20) [Time frame: through study completion, an average of 1.5 hours]
  • Self-rated lightheadedness (0-6) [Time frame: through study completion, an average of 1.5 hours]
  • Self-rated dyspnea (Modified Borg 0-10) [Time frame: through study completion, an average of 1.5 hours]
  • Heart rate reserve (peak-rest), beats/min-1 [Time frame: through study completion, an average of 1.5 hours]
Secondary outcome measures (1)
  • Modified Post-Concussion Symptom Scale (PCSS) (0-6) [Time frame: through study completion, an average of 1.5 hours]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Baylor Scott and White Sports Therapy and Research — Frisco

Identifiers

NCT: NCT05013307 · 021-143

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗