Sub-acute Exercise Following Sport-Related Concussion

Sport-related Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575455
• Other study ID #: RF02521 - TOC
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2020
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sport-related Concussion

Intervention

Behavioral:
• Exercise
HR-controlled treadmill walking

Locations

Country	Name	City	State
United States	Tallahassee Orthopedic Clinic	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	Tallahassee Orthopedic Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".
Secondary	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".
Secondary	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"
Secondary	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"
Secondary	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".
Secondary	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".
Secondary	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.
Secondary	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.