Clinical Assessment of Sports Exertion

NCT ID: NCT05013307

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-07
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

CASE

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.

Group Type: EXPERIMENTAL

CASE

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sports Academy

UNKNOWN

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baylor Scott and White Sports Therapy and Research

Frisco, Texas, United States

Countries

United States

Other Identifiers

021-143

Identifier Type: -

Identifier Source: org_study_id