Clinical Trial

Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)

Study acronym: Breathe - PED
Recruiting
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Summary
The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the acute period after concussion. Secondary objectives include documenting symptom severity (ANS related symptoms, post-concussion symptoms, anxiety, sleep) before and after administration of the intervention and examine whether early paced-breathing exercise can accelerate recovery and symptom improvement. Participants will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from the Pediatric Emergency Department. A weekly phone meeting will be performed with all participants to assess recovery progress. Participants randomized to the intervention group will also be asked about their exercises, will be provided specific instructions and adjustments as necessary. All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment, information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-01.
Trial Details
NCT Number NCT07572734
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions Concussion, Mild Traumatic Brain Injury
Enrollment 20 participants
Start Date 2026-05-01
Primary Completion 2027-05-30 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-12