Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome

Post Concussion Syndrome Clinical Trial

Official title: Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome

Status Withdrawn

Clinical Trial Summary

The general consensus in sports medicine demonstrates a graduated return to activity protocol for individuals with post-concussion syndrome. This is commonly practiced but there is insufficient literature to indicate evidence-based practice. This study will provide evidence of the effectiveness of the clinical gradual return to exercise protocols beginning after diagnosis of post-concussion syndrome through standardization and measurement of outcomes.

Clinical Trial Description

Concussion is referred to as a mild form of traumatic brain injury (mTBI) that can result in temporary loss of consciousness, memory, or awareness. mTBI can also cause physiologic symptoms such as nausea or vomiting, headaches, vestibulo-ocular dysfunction, and balance errors. The majority of individuals with mTBI will fully recover within a 7-10 day period, although adolescents may require more time to recover than adults. The American Medical Society for Sports Medicine (AMSSM) position statement on concussion management indicates that there are no standardized guidelines for return to school and return to play recommendations involve a graduated activity program once all symptoms have resolved.[1] Treatment varies amongst physicians, but it is widely held that a minimum of 5 days strict rest at home (specifically, no school, work, or physical activity) followed by a stepwise return to activity. Recent articles, however have questioned the validity of strict rest for that many days as for other similar injuries (whiplash) recommendations involve attempts to gradually resume normal activities of daily living.[2]

Individuals whose concussion symptoms do not resolve within 7-10 days are considered to have post concussion syndrome (PCS) which is ill-defined and poorly understood, however the AMSSM describes the benefit of supervised progressive exercise programs that increase tolerance as symptoms permit. The protocols in the literature for adults involve assessing the maximum threshold at which symptoms are exacerbated then have individuals perform supervised exercise at 80% of that rate,[3, 4] however this has not been done in the pediatric population and most pediatric physicians instead perform graduated activity protocols starting at a lower thresholds and increasing unless an exacerbation occurs (SORT Level of Evidence C).[5, 6] It is proposed that the fundamental cause of PCS is physiological dysfunction that fails to return to normal after a concussion. Essentially patients with a concussion are in a state of sympathetic nervous system predominance. This results in the subsequent altering of autonomic function and impaired cerebral auto regulation.[7] Aerobic exercise training may help concussion-related physiological dysfunction because exercise increases parasympathetic activity, reduces sympathetic activation, and improves cerebral blood flow. Recent articles have compared rest to activity and found slower recovery from PCS in most of the rest groups.[8]

The aim of this research is to provide documentation in the literature for an adolescent graduated activity protocol that is currently practiced in the University of Arizona Pediatric Sports Medicine Clinic. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Concussion Syndrome
• Post-Concussion Syndrome
• Syndrome

• NCT number: NCT02459145
• Study type: Interventional
• Source: University of Arizona
• Status: Withdrawn
• Phase: N/A
• Start date: June 2015
• Completion date: May 2017