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临床试验/NCT03575455
NCT03575455已完成不适用

The Short- And Long-Term Effects Of Submaximal Aerobic Exercise On Recovery Following Sport-Related Concussion In High School Student-Athletes

Florida State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Clinical Recovery

研究概览

简要总结

Determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase of recovery following sport-related concussion.

详细描述

The main objective of the proposed study is to determine is exercise during the first 3-7 days following a sport-related concussion can help improve the systemic neurological dysfunction following a concussion while examining the safety and efficacy of a 20-minute, low- to moderate-intensity (40-60% of HRMAX) controlled treadmill aerobic exercise as a therapeutic modality to improve cardiovascular, psychological, vestibulo-ocular, autonomic, and cognitive function.

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)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •(concussed):
  • •high school student-athlete
  • •suffered a diagnosed concussion
  • •evaluated between Day 3 and Day 7 since injury
  • •Inclusion Criteria (healthy):
  • •high school student-athlete
  • •no diagnosed concussion within the last year
  • •matched with concussion participant for age and gender

排除标准

  • •physical limitation prohibiting treadmill walking
  • •reports dizziness or lightheadedness
  • •presents with any contraindication for exercise participation as defined by American College of Cardiology (ACC), American Heart Association (AHA), or American College of Sports Medicine (ACSM) guidelines.

研究组 & 干预措施

Exercise

Experimental

Concussed participants will participate in a single 20' bout of treadmill walking at either 40% or 60% of the age-predicted HRmax.

Healthy participants will participate in a single 20' bout of treadmill walking at either 40% or 60% of the age-predicted HRmax.

干预措施: Exercise (Behavioral)

Seated Control

No Intervention

Concussed participants will participate in a single 20' treatment session of seated rest.

Healthy participants will participate in a single 20' treatment session of seated rest.

结局指标

主要结局

Clinical Recovery

时间窗: The number of days from injury to full medical clearance up to 365 days. 80% of adolescent athletes fully recover in less than 28 days.

Clinical recovery is defined as the duration from the time of injury to the time a patient has received full clearance without restriction.

次要结局

  • Blood Pressure (SBP & DBP)(SBP & DBP will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".)
  • Concussion Symptoms(Symptoms will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".)
  • Exercise Bout Completion Rates(Completion will be determined and recorded at the end of the acute 20 minute treatment.)
  • Heart rate variability (HRV)(HRV will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".)
  • Ocular Dysfunction(The King-Devick (K-D) will be administered before and within 5 minutes after the acute 20 minute "treatment")
  • Rating of Perceived Exertion (RPE)(RPE will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".)
  • Incidence of Persistent Postconcussion symptoms >28 days(The duration in days will be calculated from the day injury to the day full clearance up to 1 year.)
  • Vestibular Dysfunction(The Vestibular / Ocular Motor Screening (VOMS) will be administered before and within 5 minutes after the acute 20 minute "treatment")

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip Worts

Principle Investigator

Florida State University

研究点 (1)

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