Clinical Assessment of Sports Exertion

NCT05013307 | Enrolling By Invitation

• 1 other identifier: 021-143
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Return to Sport

Outcome Measures

Primary Outcomes (7)

• Heart rate (bpm)

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

  through study completion, an average of 1.5 hours

• Blood pressure (mmHg)

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

  through study completion, an average of 1.5 hours

• Oxygen Saturation (%)

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

  through study completion, an average of 1.5 hours

• Rate of Perceived Exertion (Borg 6-20)

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

  through study completion, an average of 1.5 hours

• Self-rated lightheadedness (0-6)

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

  through study completion, an average of 1.5 hours

• Self-rated dyspnea (Modified Borg 0-10)

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

  through study completion, an average of 1.5 hours

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

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

  through study completion, an average of 1.5 hours

Secondary Outcomes (1)

• Modified Post-Concussion Symptom Scale (PCSS) (0-6)

  through study completion, an average of 1.5 hours

Study Arms (1)

CASE

EXPERIMENTAL

In this prospective study the investigators aim to quantify participants' responses to physical activity. Participants will be asked to engage in physical activity, to identify any provocation of symptoms in adolescents ranging from ages 10 to 22 years. Responses to physical activity will be measured through physiologic markers (e.g., blood pressure, heart rate, oxygen saturation, rate of perceived exertion, dyspnea). Additionally, participants will be monitored for any changes in symptoms that occur during or after physical activity as measured by the modified PCSS symptom inventory.

Other: CASE

Interventions

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.

CASE

Eligibility Criteria

• Age: 10 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baylor Research Institute: lead
• Sports Academy: collaborator

Study Sites (1)

Baylor Scott and White Sports Therapy and Research

Frisco, Texas, 75034, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 19, 2021
• Study Start: August 7, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)