Sub-acute Exercise Following Sport-Related Concussion

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

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

Study Overview

• Status: Completed
• Conditions: Sport-related Concussion
• Intervention / Treatment: Behavioral: Exercise

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Orthopedic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Recovery	Clinical recovery is defined as the duration from the time of injury to the time a patient has received full clearance without restriction.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability (HRV)	The RR Interval will be extracted from the heart rate monitoring system.	HRV will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Blood Pressure (SBP & DBP)	SBP & DBP will be recorded with an automated auscultatory BP system	SBP & DBP will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Ocular Dysfunction	Improvements in ocular dysfunction will be defined as a decrease in errors or reading time	The King-Devick (K-D) will be administered before and within 5 minutes after the acute 20 minute "treatment"
Vestibular Dysfunction	Improvements in vestibular dysfunction will be defined as a decrease in symptom provocation or pretest symptom reporting	The Vestibular / Ocular Motor Screening (VOMS) will be administered before and within 5 minutes after the acute 20 minute "treatment"
Rating of Perceived Exertion (RPE)	Borg's CR-15 will be utilized to quantifying perceived intensity of exercise	RPE will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Concussion Symptoms	All 22 symptoms from the Post-concussion symptom scale (PCSS) as measured on a Likert scale from 0 (not present) to 6 (severe)	Symptoms will be captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".
Exercise Bout Completion Rates	The rate of completion will be defined as the ability for the participant to finish the "treatment" without early termination.	Completion will be determined and recorded at the end of the acute 20 minute treatment.
Incidence of Persistent Postconcussion symptoms >28 days	Persistent symptoms duration will be categorized as either ≤28 days or > 28 days.	The duration in days will be calculated from the day injury to the day full clearance up to 1 year.

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: Tallahassee Orthopedic Clinic

Publications and helpful links

General Publications

• Worts PR, Mason JR, Burkhart SO, Sanchez-Gonzalez MA, Kim JS. The acute, systemic effects of aerobic exercise in recently concussed adolescent student-athletes: preliminary findings. Eur J Appl Physiol. 2022 Jun;122(6):1441-1457. doi: 10.1007/s00421-022-04932-4. Epub 2022 Mar 18.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: aerobic exercise; concussion; sub-acute
• Other Study ID Numbers: RF02521 - TOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No