Baylor Scott and White Sports Concussion Program Clinical Assessment of Sports Exertion Research Proposal
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Heart rate reserve (peak-rest), beats/min-1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: CASE (Other)
结局指标
主要结局
Heart rate reserve (peak-rest), beats/min-1
时间窗: through study completion, an average of 1.5 hours
Using metabolic cart, heart rate reserve will be recorded via Garmin heart rate strap.
Heart rate (bpm)
时间窗: through study completion, an average of 1.5 hours
Using pulse oximeter placed on index finger heart rate will be recorded.
Oxygen Saturation (%)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Blood pressure (mmHg)
时间窗: through study completion, an average of 1.5 hours
Using a manual cuff and auscultation method diastolic and systolic scores will be recorded.
次要结局
- Modified Post-Concussion Symptom Scale (PCSS) (0-6)(through study completion, an average of 1.5 hours)
研究者
Kayla Covert
Principal Investigator
Baylor Research Institute