Sub-acute Exercise Following Sport-Related Concussion

NCT03575455 | Completed

• 1 other identifier: RF02521 - TOC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sport-related Concussion

Keywords

concussion; aerobic exercise; sub-acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Heart rate variability (HRV)

  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 captured for 10 minutes before, 20 minutes during, and after 25 minutes post "treatment".

• Ocular Dysfunction

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

• Vestibular Dysfunction

  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)

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

Study Arms (2)

Exercise

EXPERIMENTAL

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

Seated Control

NO INTERVENTION

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.

Interventions

Exercise BEHAVIORAL

HR-controlled treadmill walking

Also known as: Aerobic exercise

Exercise

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• high school student-athlete
• suffered a diagnosed concussion
• evaluated between Day 3 and Day 7 since injury
• high school student-athlete
• no diagnosed concussion within the last year
• matched with concussion participant for age and gender

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead
• Tallahassee Orthopedic Clinic: collaborator

Study Sites (1)

Tallahassee Orthopedic Clinic

Tallahassee, Florida, 32308, United States

Location

Related Publications (1)

• 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.

  PMID: 35303160 DERIVED

MeSH Terms

Conditions

Brain Concussion

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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)

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: July 2, 2018
• Study Start: January 2, 2017
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)