Is early activity resumption after paediatric concussion safe and does it reduce symptom burden at 2 weeks post injury? The Pediatric Concussion Assessment of Rest and Exertion (PedCARE) multicentre randomised clinical trial

Abstract

ObjectiveInvestigate whether resuming physical activity (PA) at 72 hours post concussion is safe and reduces symptoms at 2 weeks, compared with resting until asymptomatic.MethodsReal-life conditions, multicentre, single-blinded randomised clinical trial, conducted in three Canadian paediatric emergency departments (ED). Children/youth aged 10–<18 years with acute concussion were recruited between March 2017 and December 2019, and randomly assigned to a 4-week stepwise return-to-PA protocol at 72 hours post concussion even if symptomatic (experimental group (EG)) or to a return-to-PA once asymptomatic protocol (control group (CG)). The primary outcome was self-reported symptoms at 2 weeks using the Health and Behaviour Inventory. Adherence was measured using accelerometers worn 24 hours/day for 14 days post injury. Adverse events (AE) (worsening of symptoms requiring unscheduled ED or primary care visit) were monitored. Multivariable intention-to-treat (ITT) and per-protocol analyses adjusting for prognostically important covariates were examined. Missing data were imputed for the ITT analysis.Results456 randomised participants (EG: N=227; mean (SD) age=13.3 (2.1) years; 44.5% women; CG: N=229; mean (SD) age=13.3 (2.2) years; 43.7% women) were analysed. No AE were identified. ITT analysis showed no strong evidence of a group difference at 2 weeks (adjusted mean difference=−1.3 (95% CI:−3.6 to 1.1)). In adherent participants, initiating PA 72 hours post injury significantly reduced symptoms 2 weeks post injury, compared with rest (adjusted mean difference=−4.3 (95% CI:−8.4 to –0.2)).ConclusionSymptoms at 2 weeks did not differ significantly between children/youth randomised to initiate PA 72 hours post injury versus resting until asymptomatic; however, many were non-adherent to the intervention. Among adherent participants, early PA was associated with reduced symptoms at 2 weeks. Resumption of PA is safe and may be associated with milder symptoms at 2 weeks.Level of evidence1b.Trial registration numberNCT02893969.Registry namePediatric Concussion Assessment of Rest and Exertion (PedCARE).

Randomized controlled trial of early aerobic exercise following sport-related concussion: Progressive percentage of age-predicted maximal heart rate versus usual care

“…The SAEP group received two in-person supervised sessions as well as remote supervision and reminders for exercise. These sessions may have accounted for some of the differences between groups by increasing the confidence of study participants in their treatment prescription or ensuring adherence to study procedures [ 47 ]. However, participants in both groups had access to interventions, academic accommodations, physical therapy, and pharmacological options associated with sleep, headache, or affective issues, consistent with current guidelines.…”

Adolescents with a concussion have altered brain network functional connectivity one month following injury when compared to adolescents with orthopedic injuries

“…Although the PedCARE trial randomized concussion participants to either resume non-contact, aerobic physical activity at 72 h post-concussion or rest until asymptomatic, the concussion participants were regrouped and the randomization was broken for the purposes of this study as both groups completed similar levels of physical activity ( Ledoux et al, 2021 ). The study herein is a cross sectional design of the data collected for PedCARE +MRI .…”

“…Sex was also covaried as reduced connectivity post-concussion was recently identified in females within and between multiple regions ( Shafi et al, 2020 ). To account for the possibility of group differences between the physical activity and rest concussion groups [despite no significant activity level differences ( Ledoux et al, 2021 )], assigned groups were added as covariates. For the purposes of this analysis, each participant was assigned a composite diagnostic score that was the sum of: 1 point per prior diagnosis of ADHD, anxiety, depression or learning disability; and total number of previous concussions.…”

Regional Blood Flow Alterations Following Pediatric Concussion: A PedCARE+MRI Substudy

“…This study is a planned secondary analysis of a randomized clinical trial (RCT) completed at CHEO from May 2018 to February 2020 called Pediatric Concussion Assessment of Rest and Exertion+MRI (PedCARE +MRI ), which was an adjunct study to Pediatric Concussion Assessment of Rest and Exertion (PedCARE) Ledoux et al, 2022). The primary objective of the PedCARE +MRI study was to investigate whether early resumption of physical activity at 72 hours post-concussion would lead to improved neurophysiological outcomes.…”

“…Although the parent study was an RCT, for this study the physical activity and rest until asymptomatic groups were combined, since it was previously found that the groups had similar patterns of physical activity (Ledoux et al, 2022). Recruitment took place through CHEO's Emergency Department.…”