Return to SportCASENCT05013307
Clinical Assessment of Sports Exertion
A study testing CASE in people with Return to Sport, run by Baylor Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Return to Sport
- What is being tested?
- CASE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor Scott and White Sports Therapy and Research
Frisco, Texas, 75034
About this study
Official title: Baylor Scott and White Sports Concussion Program Clinical Assessment of Sports Exertion Research Proposal
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
- Being tested
- CASE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CASE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (bpm)
Using pulse oximeter placed on index finger heart rate will be recorded.
Measured: 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.
Measured: through study completion, an average of 1.5 hours
Oxygen Saturation (%)
Using pulse oximeter placed on index finger oxygen saturation will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1.5 hours
Secondary outcomes (1)
Modified Post-Concussion Symptom Scale (PCSS) (0-6)
Using modified PCSS, self report measure of symptoms will be recorded. A high number indicates worse symptoms.
Measured: through study completion, an average of 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start7 Aug 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Return to SportStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sports Academy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013307
- Sponsor's protocol ID
- 021-143
- Acronym
- CASE
- Status last verified
- Feb 2026
- First submitted
- 4 Aug 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baylor Scott and White Sports Concussion Program Clinical Assessment of Sports Exertion Research Proposal
- ClinicalTrials.gov ID
- NCT05013307
- Acronym / sponsor ID
- CASE / 021-143
- Conditions
- Return to Sport
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Sports Academy
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CASE | Experimental | Other: CASEIn 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. |
Who may qualify
- Ages
- 10 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASEThe 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. | Other | CASE |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Modified Post-Concussion Symptom Scale (PCSS) (0-6)
Time frame: through study completion, an average of 1.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASE in people with Return to Sport, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (bpm) (time frame: through study completion, an average of 1.5 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.