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Sub-acute Exercise Following Sport-Related Concussion

Not Applicable
Completed
Conditions
Sport-related Concussion
Interventions
Behavioral: Exercise
Registration Number
NCT03575455
Lead Sponsor
Florida State University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ExerciseExerciseConcussed 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.
Primary Outcome Measures
NameTimeMethod
Clinical RecoveryThe 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
NameTimeMethod
Blood Pressure (SBP & DBP)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

Concussion SymptomsSymptoms 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)

Exercise Bout Completion RatesCompletion 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.

Heart rate variability (HRV)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.

Ocular DysfunctionThe 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

Rating of Perceived Exertion (RPE)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

Incidence of Persistent Postconcussion symptoms >28 daysThe 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.

Vestibular DysfunctionThe 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

Trial Locations

Locations (1)

Tallahassee Orthopedic Clinic

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Tallahassee, Florida, United States

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