The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.
研究概览
简要总结
Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.
详细描述
There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment
- •Low or moderate cardiac risk according to American College of Sports Medicine
- •Post-Concussion Symptom Scale (PCSS) score greater than 9
排除标准
- •History of neurological surgery
- •Seizure disorder
- •Use of medication or medical device that would alter heart rate, blood pressure or autonomic function
- •Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
Exercise Intervention Group
Thse patients will undergo a sub-maximal exercise training as treatment for concussion.
干预措施: Sub-maximal exercise (Other)
Usual Care Group
These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
结局指标
主要结局
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.
时间窗: The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.
Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem).
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.
时间窗: Measured at initial visit and 8-weeks.
Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer.
次要结局
- End-tidal CO2(Measured at initial visit and 8-week post injury visit.)
- Volume of Self-reported Exercise Per Week(Average volume of exercise (min) that was self-reported by participants over the 8-week study period.)
- Heart Rate(Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.)
- Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.(Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic)
研究者
William Meehan III
MD
Boston Children's Hospital