跳至主要内容
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 University2 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

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
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

入选标准

  • 未提供

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.

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 (2)

Loading locations...

相似试验