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Post-acute Structured Exercise Following Sport Concussion

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StatusRecruiting
Sponsors
University of Toronto

Keywords

Abstract

This study will investigate the effect of standardized aerobic exercise (AE) compared to rest on clinical recovery from sport-related concussion (SRC) within the post-acute phase of injury. Participants will be randomized into one of two groups: (1) Aerobic Exercise Group: participants will complete a total of eight exercise sessions over the course of 11 days, starting at Day 3 post-injury; (2) Usual Care Group: individuals will undergo a period of physical rest and standard care until symptoms spontaneously resolve. For the purposes of this study, "rest" will be defined as the avoidance of any activities beyond those of daily living, including participation in sport and physical activity.

Description

A number of physical, cognitive, somatic, and emotional symptoms commonly occur following sports-related concussion. The current return to play (RTP) protocol advises complete physical and cognitive rest following SRC until patients are completely free of these symptoms (i.e. asymptomatic) in order to avoid making symptoms worse and furthering the injury. While this initial, post-injury rest period is generally assumed to be beneficial, there is currently no scientific evidence supporting this recommendation. In fact, a growing body of evidence suggests that prolonged rest may actually hinder the recovery process.

Emerging research is beginning to show that light-to-moderate aerobic exercise (AE) actually provides a positive benefit on the injured brain, thereby helping the recovery process. Research has shown this benefit in concussion and other injuries such as stroke, whiplash, and low back pain. In fact, a standardized aerobic exercise protocol has been shown to improve recovery for individuals with persistent symptoms for an extended period of time. While preliminary human investigations using AE interventions after concussion have shown promise, these studies are either retrospectively designed, or have focused on individuals with persistent symptoms (> 3 weeks).

Therefore, the purpose of this study is to examine the effect of a standardized, subacute AE intervention in adolescents after SRC, on time to recovery compared to usual care. This study will provide meaningful information regarding the utility of AE intervention after concussion. Findings from these works may inform future usual care procedures post-injury, potentially providing the first known treatment to improve recovery after concussion.

Dates

Last Verified: 03/31/2018
First Submitted: 10/31/2016
Estimated Enrollment Submitted: 11/15/2016
First Posted: 11/20/2016
Last Update Submitted: 04/04/2018
Last Update Posted: 04/08/2018
Actual Study Start Date: 02/15/2017
Estimated Primary Completion Date: 12/31/2020
Estimated Study Completion Date: 03/31/2021

Condition or disease

Concussion, Brain

Intervention/treatment

Behavioral: Aerobic Exercise Group

Phase

-

Arm Groups

ArmIntervention/treatment
No Intervention: Usual Care Group
These individuals will undergo a period of physical rest and standard care until symptoms spontaneously resolve. For the purposes of this study, "rest" will be defined as the avoidance of any activities beyond those of daily living, including participation in sport and physical activity. Once individuals in this group achieve asymptomatic status, they will be directed through the existing return to play guidelines.
Experimental: Aerobic Exercise Group
These individuals will begin to exercise at Day 3 post-injury. These participants will be asked to complete a total of eight exercise sessions over the course of 11 days, with one day of rest after two consecutive sessions. Once individuals in this group achieve asymptomatic status, they will be directed through the existing return to play guidelines.
Behavioral: Aerobic Exercise Group
The AE protocol will consist of eight sessions that proceed in a stepwise fashion in terms of duration and intensity over 11 days. Exercise will be performed on the Velotron Pro stationary cycle ergometer (RacerMate Inc., WA, USA), which will be digitally connected to a heart rate monitor and programmed to monitor the wattage of the bike based on the participant's heart rate. Exercise duration (15min-20min) and intensity (60%-75% max HR) will increase over the intervention period.

Eligibility Criteria

Ages Eligible for Study 13 Years To 13 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- Diagnosed with SRC by a physician at the David L. MacIntosh Sport Medicine Clinic

- Minimum of 13 years of age and a maximum of 25 years of age

- Able to speak and understand English

Exclusion Criteria:

- Have had a previous concussion within two weeks of the presenting SRC

- Have any co-morbid injuries (i.e. musculoskeletal/soft-tissue injuries, vestibular disorders)

- Have a pre-existing heart condition

- Have any uncontrolled seizure disorders or a history of medical or neurological conditions that affects cognitive functioning

Outcome

Primary Outcome Measures

1. Clinical recovery - Days to Medical Clearance [Up to 1-year post-injury]

Number of days from the time of injury until a concussed athlete is cleared to return to play by a sport-medicine physician.

Secondary Outcome Measures

1. Change in Symptoms [28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury]

Concussion-related symptoms will be assessed using the Post-Concussion Symptom Scale (PCSS) of the Sport Concussion Assessment Tool-3 (SCAT3). The symptom score is comprised of a 22-item post-concussion symptom scale using a seven-point Likert scale rating. Total symptoms is the total number of symptoms with a non-zero score and symptom severity is obtained by summing the rated symptom score for each symptom.

2. Change in Heart Rate Variability (HRV) [28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury]

Heart Rate Variability (HRV) will be assessed using the Polar heart rate V800 sports watch and corresponding chest strap heart monitor (Polar ®, QC, Canada). HRV will be assessed for 5 minutes in the supine position, followed by a 1-minute accommodation period, a final five-minute HRV assessment in the upright-seated position will be performed. HRV measurements to be analyzed HRV was assessed using both time domain and frequency domain measures, in accordance with recommendations of the Task Force of the European Society Cardiology and North American Society of Pacing and Electrophysiology.

3. Change in Blood Pressure Variability (BPV) [28 days: assessed at Days 7, 14, 21, 28, and 90 post-injury]

Blood Pressure Variability (BPV) will be measured using the Finapres MIDI figure cuff device concurrently with HRV. Systolic BP and diastolic BP values will be acquired throughout the acquisition period.

4. Change in Peripheral Blood Biomarkers [28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury]

Peripheral blood samples (approximately 20 mL) will be drawn from participants by a trained phlebotomist. High sensitivity multiplexed immunoassay will be employed to quantitate 30 inflammatory cytokines and chemokines, and 11 central nervous-injury specific biomarkers. Individual biomarker values will be excluded if they were above or below the manufacturers' recommended level of quantitation for each analyte, or displayed a coefficient of variance >25% between duplicates. Because multiple 96-well plates will analyzed, inter-plate variance will also be accounted for; therefore, plates will only be included in the statistical analysis if the inter-plate variance was <20%, calculated from internal control samples acquired on each plate. Raw values of biomarker analyte will be used in all analyses.

5. Change in Cognition [28 Days: assessed at Days 7, 14, 21, 28, and 90 post-injury]

C3 Logix (iPad platform, Cleveland, OH, USA), will be employed to measure reaction time, information processing speed, visual acuity, and postural stability. This assessment will take approximately 10-15 minutes to complete. For each of subtest, the percent correct (accuracy) and reaction time (ms) will be analyzed.

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