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Sub-acute Exercise Following Sport-Related Concussion

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ClinicalTrials.gov Identifier: NCT03575455
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Tallahassee Orthopedic Clinic
Information provided by (Responsible Party):
Phillip Worts, Florida State University

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

Condition or disease Intervention/treatment Phase
Sport-related Concussion Behavioral: Exercise Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized block design using age and sex to randomize into 3 injured groups (40%, 60%, CON) and matching for 3 healthy groups (40%, 60%, CON)
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Short- And Long-Term Effects Of Submaximal Aerobic Exercise On Recovery Following Sport-Related Concussion In High School Student-Athletes
Actual Study Start Date : January 2, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : July 1, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise

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.

 Behavioral: Exercise
HR-controlled treadmill walking
Other Name: Aerobic exercise
No Intervention: Seated Control

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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575455


Locations
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United States, Florida
Tallahassee Orthopedic Clinic
Tallahassee, Florida, United States, 32308
Sponsors and Collaborators
Florida State University
Tallahassee Orthopedic Clinic
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Phillip Worts, Principle Investigator, Florida State University
ClinicalTrials.gov Identifier: NCT03575455    
Other Study ID Numbers: RF02521 - TOC
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phillip Worts, Florida State University:
concussion
aerobic exercise
sub-acute