The Effects of Early Prescribed Aerobic Exercise on Recovery and Post-concussive Symptoms in Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percentage of Participants Recovered
研究概览
简要总结
This study is looking at the specific role of an exercise prescription on recovery from concussion symptoms in the general population.
详细描述
435 people will participate in this study.
A physician will review a participant's medical history to determine if physical activity is appropriate for them. They will then be randomly assigned to 1 of 3 study groups:
- Monitoring- participants will be given a heart rate monitor to wear on their wrist for the duration of the study (until "recovered", or until 8 weeks post-concussion, whatever comes first).
- Monitoring + Treadmill Testing- in addition to wearing the heart rate monitor, they will undergo a treadmill test at each appointment.
- Monitoring + Treadmill Testing + Specific Exercise Prescription- in addition to wearing the heart rate monitor, and treadmill test, they will receive an exercise prescription based on the results of the treadmill test.
The randomization is by chance. Participants have a 40/20/40% respective chance of being assigned to the study groups above. This means that out of every 5 people: 2 people will be assigned to the group 1, 1 will be assigned to the group 2, and 2 will be assigned to the group 3. Both participants and the study doctor will be aware which group participants are in.
Regardless of the group assigned, participants will receive an exercise prescription form at each appointment, as per usual care. The prescription will be based on the physician's judgement. If a participant is in group 3, their prescription will also take into account the results of the treadmill test.
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
- Single (Outcomes Assessor)
盲法说明
The primary outcome (recovery) is determined using a 3 step approach. Each assessor responsible for one of the three steps, will be blind to at least ONE other recovery determinant.
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that provide written informed consent prior to entry into the study
- •Patients referred from the emergency department (ED) with recent (<1 week) diagnosis of concussion by ED physician
- •GCS score of 13-15 on presentation to the ED
- •SCAT score > 9 at week 1
- •Physician cleared for exercise; low risk for cardiac disease (defined as no cardiopulmonary symptoms and meet no more than one risk factor for heart disease)
- •Willing to exercise
排除标准
- •Evidence of intracranial hemorrhage, contusion or injury on brain imaging (CT Scan)
- •Beta-blocker medication
- •High dose (>50mg/day) tricyclic antidepressant medication
- •Pre-existing or current orthopedic injuries preventing exercise
- •Pre-existing vestibular disease preventing exercise
- •Heartrate increase <30 bpm from rest on treadmill test
- •Deemed asymptomatic from concussion by clinic physician
- •Unable/unwilling to follow commands
结局指标
主要结局
Percentage of Participants Recovered
时间窗: Assessed at week 8 post-concussion.
"Recovery" (yes/no) will be determined using a 3-step approach: 1. Self-reported symptoms (using the Sport Concussion Assessment Tool \[SCAT\], Symptom Inventory), 2. Clinic physician's opinion, 3. Treadmill test results (if applicable).
次要结局
- Percentage of Participants who have Returned to Work/School(Assessed at week 8 post-concussion.)
- Percentage of Participants Recovered(Assessed at week 4 post-concussion.)
- Brief Symptom Inventory-18 (BSI-18) Global Severity Index Score(Assessed at week 8 post-concussion.)