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Recruiting Not applicable

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

NCT07572734 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-05-12

Condition(s) studied

Concussion, Mild Traumatic Brain Injury

Investigational drug(s) / intervention(s)

Paced breathing exercises

Paced breathing exercises: The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.

Study 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.

Eligibility

Sex
ALL
Min age
9 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 9-18 years old * 0-72 hours post-concussion * present to the ED with at least one post-concussion symptom in the Post-concussion Symptom Inventory (PSCI) that is relevant to ANS dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety or sleep disturbances) Exclusion Criteria: * known heart disease, * previous neurological problems other than concussion

Primary outcome measure(s)

  • Feasibility-days of practice — 4 weeks
    Number of days children in the experimental group will engage in performing their breathing exercises
  • Feasibility-daily duration of practice — 4 weeks
    Number of minutes children in the experimental group will engage in performing their breathing exercises

Trial sites (1)

FacilityCityRegionStatus
Montreal Children's Hospital Montreal Quebec Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07572734 on ClinicalTrials.gov ↗ ← All trials in Canada