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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
  1. Andrée-Anne Ledoux1,2,
  2. Nick Barrowman3,4,
  3. Vid Bijelić3,
  4. Michael M Borghese5,
  5. Adrienne Davis6,
  6. Sarah Reid1,7,
  7. Gurinder Sangha8,
  8. Keith Owen Yeates9,10,
  9. Mark S Tremblay1,4,
  10. Candice McGahern1,
  11. Kevin Belanger1,
  12. Joel D Barnes1,
  13. Ken J Farion1,7,
  14. Carol A DeMatteo11,
  15. Nick Reed12,
  16. Roger Zemek1,7
  17. PERC PedCARE Concussion team
    1. 1Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada
    2. 2Cellular and Molecular Medicine- Neuroscience, University of Ottawa, Ottawa, Ontario, Canada
    3. 3Clinical Research Unit, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada
    4. 4Department of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada
    5. 5Environmental Health Science and Research Bureau, Health Canada, Ottawa, Ontario, Canada
    6. 6Division of Pediatric Emergency Medicine, Department of Pediatrics, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada
    7. 7Division of Emergency Medicine, Department of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada
    8. 8Division of Emergency Medicine, Department of Pediatrics, Western University, London, Ontario, Canada
    9. 9Department of Psychology, University of Calgary, Calgary, Alberta, Canada
    10. 10Alberta Children’s Hospital Research Institute and Hotchkiss Brain Institute, University of Calgary, Alberta, Canada
    11. 11School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
    12. 12Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada
    1. Correspondence to Dr Andrée-Anne Ledoux, Emergency Reseach Department, Children's Hospital of Eastern Ontario, Ottawa, ON K1H 8L1, Canada; aledoux{at}cheo.on.ca

    Abstract

    Objective Investigate whether resuming physical activity (PA) at 72 hours post concussion is safe and reduces symptoms at 2 weeks, compared with resting until asymptomatic.

    Methods Real-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.

    Results 456 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)).

    Conclusion Symptoms 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 evidence 1b.

    Trial registration number NCT02893969.

    Registry name Pediatric Concussion Assessment of Rest and Exertion (PedCARE).

    • brain concussion
    • randomized controlled trial
    • physical activity
    • pediatrics
    • rest

    Data availability statement

    Data are available upon reasonable request. The data that support the findings of this study are available on reasonable request from the corresponding author in accordance to ethical and legal regulations regarding the sharing of information as to prevent compromising the privacy of research participants.

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    Data availability statement

    Data are available upon reasonable request. The data that support the findings of this study are available on reasonable request from the corresponding author in accordance to ethical and legal regulations regarding the sharing of information as to prevent compromising the privacy of research participants.

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    Footnotes

    • Collaborators PERC PedCARE Concussion team: Candice McGahern, BA; Tyrus Crawford, BA; Lauren Dawson, MSc, RPN; Katie Healey, BA; Sarah Reid, MD; Ken J Farion, MD; Andrée-Anne Ledoux, PhD; Roger Zemek, MD; Gurinder Sangha, MD; Adrienne Davis, MD; Nicolas Reed, PhD; Carol DeMatteo, MSc; Keith O Yeates, PhD; Mark Tremblay, PhD; Michael Borghese, PhD.

    • Contributors RZ and A-AL had full access to all of the data (except were blinded to the groups) in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Design and conduct of the study: A-AL, MST, CAD, KY, KF, SR, NR and RZ. Collection, management, analysis and interpretation of the data: A-AL, NB, VB, MMB, AD, SR, KF, GS, MST, KB, JB, KY and RZ. Preparation, review or approval of the manuscript: A-AL, NB, VB, MMB, AD, SR, KF, GS, MST, KY, KB, JB, CAD, NR and RZ. Acting guarantor: A-AL and RZ. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

    • Funding This study was supported by OSSU IMPACT Award.

    • Disclaimer The funders acknowledged herein had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication.

    • Competing interests KY reported being one of the authors of the Health and Behaviour Inventory (HBI); the HBI is freely available and he receives no financial benefit for its use. There are no other conflicts of interest relevant to this article to disclose. RZ is scientific director and minority shareholder in 360 Concussion Care, an interdisciplinary concussion clinic. RZ and KY are investigators in a multicentre study funded by the National Football League (NFL) Scientific Advisory Board; they do not receive any financial benefit. There are no other conflicts of interest relevant to this article to disclose.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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