A Physiological and Clinical Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Changes in Concussion Symptoms From Pre to Post Exercise
研究概览
简要总结
Primary Aim: Compare physiological (e.g., heart rate) and clinical responses (e.g., symptom provocation) of adolescent and adult athletes (14-35 years of age) completing either a structured treadmill running or a dynamic aerobic exertion protocol during the subacute phase of sport-related concussion recovery (3-30 days after injury).
Secondary Aim: Examine potential effects of clinically-relevant factors that influence symptom responses to controlled aerobic exertion, such as age, physical activity patterns, motion sensitivities, psychological responses to injury, and sleep quality, among subjects completing controlled aerobic and dynamic exertion following sport-related concussion
详细描述
Exercise testing is an emerging component of the clinical evaluation for sport-related concussion. Despite the growing empirical evidence to suggest that early activity following an initial rest period after injury is beneficial to recovery, the effects of modifiable exercise prescription factors (e.g., exercise mode, duration, and intensity) is unknown. Given that dynamic exertion, which incorporates synchronized head-body movements, may contribute greater information processing demands for the functional pathways responsible for balance and equilibrium than treadmill running, may be more likely to provoke symptoms during exertion. Thus, physically active (>150 min/week of moderate-intensity physical activity) participants prior to a diagnosed sport-related concussion will be randomly assigned to complete either an aerobic or dynamic exercise task at 1 study visit following injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
Care provider will not be aware of group assignment; participant will be aware of intervention assessment
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 14-35
- •Prior to injury, participant fulfilled ACSM's guidelines for regular aerobic activity (30 minutes of moderate-intensity exercise 5 days per week or 20 minutes of vigorous exercise 3 days per week) prior to injury.
- •Diagnosed with a sport related concussion within 14 days of injury in the window of 3-30 days prior to completing the first study visit, and also being a single episode.
- •Participants referred to exertion therapy after a trained clinician from University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program has interpreted neurocognitive, vestibular, and clinical interview outcomes
排除标准
- •History of brain surgery or traumatic brain injury(based on Glasgow Coma Scale of <13)
- •History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations)
- •Current history of pre-existing vestibular disorder [benign paroxysmal positional vertigo (BPPV), labyrinthitis or vestibular neuritis]
- •Previous diagnosis of ocular motor condition (Ocular motor apraxia)Currently taking anticoagulant, beta-blockers, and anticonvulsant prescription medication
- •Diagnosed with a cardiac, peripheral, or cerebrovascular disease (type 1 or 2 diabetes, or renal disease.
- •Experienced chest pain or shortness of breath while at rest or with mild exertion.
- •Lose balance because of dizziness or have lost consciousness (aside from concussion) from exertion
- •Diagnosed with or taking medication for a chronic medical condition
- •Currently have a mental or physical impairment exacerbated by physical activity, leading to the inability to complete 30 minutes of moderate to vigorous exercise
- •Been told by a doctor to only conduct physical activity under medical supervision.
结局指标
主要结局
Changes in Concussion Symptoms From Pre to Post Exercise
时间窗: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
Concussion symptoms will be measured with the Post-concussion Symptom Scale (PCSS), a patient-report survey of 22 concussion-associated symptoms on a 0-6 Likert scale (0 'none' to 6 'severe'). Number of reported symptoms (range: 0- 22) and total symptom severity (range: 0-132) whereby greater scores indicate worse symptom burden will be examined. The survey takes approximately 5 minutes to complete
Heart Rate
时间窗: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
Actual and percent of age-estimated heart rate, measured in beats per minute , will be recorded prior to (approximately 5 min), during, and following (approximately 5 min) exercise via a noninvasive heart rate monitor. Heart rate at rest, exercise cessation, and their difference (maximum heart rate - resting heart rate) will be recorded.
Exercise duration
时间窗: Completed during the 1 study visit within 30 days following concussion
Exercise duration, the time interval between exercise initiation and cessation, will be recorded in seconds (range: 0-900)
Clinical recovery
时间窗: Through study completion, approximately between 3 and 30 days following concussion
Duration of clinical recovery, measured in days, is the interval between injury onset until medical clearance to resume unrestricted sport participation.
Systolic and Diastolic Blood Pressure
时间窗: At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation
Systolic and diastolic blood pressure, measured in mmHg with a non-invasive blood pressure cuff, will be recorded prior to and following exercise intervention.
次要结局
- Changes in vestibular ocular motor screening (VOMS) symptoms from pre-exercise to post-exercise(At 1 study visit within 30 days following concussion, and within 15 minutes of initiating exercise until approximately 15 minutes after exercise cessation)
研究者
Anthony P. Kontos, Ph.D.
Associate Professor
University of Pittsburgh