Trial of Aerobic Treadmill Exercise Treatment for Concussion

NCT02674620 | Completed

• 1 other identifier: B2015:020
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

A post-concussion syndrome (PCS) diagnosis has historically led to a recommendation of continued mental and physical rest to minimize symptoms. However, this conservative approach does not consider the pathophysiological mechanisms and neurological subsystem dysfunction which mediate persistent signs and symptoms. Recently, developing research is recommending targeted therapies for specific post-concussion disorders (physiologic, vestibulo-ocular and cervicogenic). The Buffalo Concussion Treadmill Test (BCTT) is a graded aerobic test that has emerged as safe, reliable, and effective in distinguishing between post-concussion syndrome sub-types, quantifying physiological recovery, and guiding return to play decision making. It has been proposed that the results of a BCTT can be used to prescribe progressively intensifying whole body aerobic exercise (such as walking or biking), maintained at a sub-symptom threshold, to improve autoregulatory function with the potential to improve PCS symptoms. Positive results with BCTT have now made it the standard of care at the University of Buffalo Concussion Clinic and Pan Am Clinic during the management of sport related concussions. Despite its increased use in patients with post-concussion syndrome there is currently no data on the use of exercise treatment in the early stages of concussion recovery.

Conditions

Concussion

Outcome Measures

Primary Outcomes (1)

• Number of days from injury to full recovery

  To be considered at "Full recovery", participant must meet the following criteria - Asymptomatic at rest (PCSS score under 7), participating in full school activities (as pre-injury) without symptoms, normal neurological exam, and normal vestibulo-ocular exam

  From date of injury (day 0) to date of recovery of symptoms (as defined in Outcome measure) or when the patient is discharged from care, whichever came first, assessed up to 180 days post-injury

Study Arms (2)

Conservative

NO INTERVENTION

Standard conservative care of concussion

Treadmill

EXPERIMENTAL

Aerobic exercise treatment for concussion

Other: Aerobic Exercise

Interventions

Aerobic Exercise OTHER

Patients are treated with progressive exercise

Treadmill

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Must meet the diagnostic criteria of a concussion set forth by the Consensus Statement on Concussion in Sport 4th Annual Conference of Concussion in Sport, 2013 as determined by the treating neurosurgeon.
• Presence of concussion-related symptoms at the time of testing.
• Glasgow coma scale (GCS)=15
• Patients for who parental consent can be obtained.

You may not qualify if:

• Patients with a history of moderate or severe traumatic brain injury, epilepsy, or stroke.
• Patients who have been diagnosed with a skull fracture, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intraparenchymal hemorrhage, or cerebral contusion on previous neuro-imaging studies.
• Pregnant female patients.
• GCS ≤ 14.
• Patients with contraindications to exercise testing as assessed by PARmed-X assessment.
• Patients for who parental consent can not be obtained.

Sponsors & Collaborators

• Panam Clinic: lead

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Related Publications (2)

• Leddy JJ, Baker JG, Kozlowski K, Bisson L, Willer B. Reliability of a graded exercise test for assessing recovery from concussion. Clin J Sport Med. 2011 Mar;21(2):89-94. doi: 10.1097/JSM.0b013e3181fdc721.

  PMID: 21358497 BACKGROUND

• Leddy JJ, Kozlowski K, Fung M, Pendergast DR, Willer B. Regulatory and autoregulatory physiological dysfunction as a primary characteristic of post concussion syndrome: implications for treatment. NeuroRehabilitation. 2007;22(3):199-205.

  PMID: 17917170 BACKGROUND

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 Officials

• Jeff R Leiter, PhD

  Pan Am Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 4, 2016
• Study Start: June 1, 2015
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: March 20, 2019

Record last verified: 2018-02

Locations

CA (1)