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Completed

NCT Number: NCT03575455

Sub-acute Exercise Following Sport-Related Concussion

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

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Key information

Conditions

Sport-related Concussion Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Orthopedic Clinic

Tallahassee, Florida, 32308, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(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

Exclusion criteria

  • 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.

Treatment and study plan

Exercise

Behavioral

HR-controlled treadmill walking

Other names: Aerobic exercise

Primary outcomes

  1. Clinical Recovery

    Time frame: 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.

Secondary outcomes

  1. Heart rate variability (HRV)

    Time frame: HRV will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".

    The RR Interval will be extracted from the heart rate monitoring system.

  2. Blood Pressure (SBP & DBP)

    Time frame: SBP & DBP will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".

    SBP & DBP will be recorded with an automated auscultatory BP system

  3. Ocular Dysfunction

    Time frame: The King-Devick (K-D) will be administered before and within 5 minutes after the acute 20 minute "treatment"

    Improvements in ocular dysfunction will be defined as a decrease in errors or reading time

  4. Vestibular Dysfunction

    Time frame: The Vestibular / Ocular Motor Screening (VOMS) will be administered before and within 5 minutes after the acute 20 minute "treatment"

    Improvements in vestibular dysfunction will be defined as a decrease in symptom provocation or pretest symptom reporting

  5. Rating of Perceived Exertion (RPE)

    Time frame: RPE will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".

    Borg's CR-15 will be utilized to quantifying perceived intensity of exercise

  6. Concussion Symptoms

    Time frame: Symptoms will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".

    All 22 symptoms from the Post-concussion symptom scale (PCSS) as measured on a Likert scale from 0 (not present) to 6 (severe)

  7. Exercise Bout Completion Rates

    Time frame: Completion will be determined and recorded at the end of the acute 20 minute treatment.

    The rate of completion will be defined as the ability for the participant to finish the "treatment" without early termination.

  8. Incidence of Persistent Postconcussion symptoms >28 days

    Time frame: The duration in days will be calculated from the day injury to the day full clearance up to 1 year.

    Persistent symptoms duration will be categorized as either ≤28 days or > 28 days.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Tallahassee Orthopedic Clinic

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 2, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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