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Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion

Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06559865
Acronym
Breathe
Enrollment
20
Registered
2024-08-19
Start date
2024-06-01
Completion date
2024-12-15
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion, Mild

Brief 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 sub-acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention. Participants will: 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 a concussion follow-up program. A weekly phone meeting will be performed with the participants, to review exercise, providing, specific instructions, and making any necessary adjustments. 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.

Interventions

BEHAVIORALBreathing exercises

as per group description

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* aged 9-18 years * seven days-3 months post-concussion, * 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility-days of practice4 weeksnumber of days children in the experimental group will engage in performing their breathing exercises
Feasibility-daily duration of practice4 weeksnumber of minutes children in the experimental group will engage in performing their breathing exercises

Secondary

MeasureTime frameDescription
Autonomic nervous system function-Heart rateinitial and 4 week evaluationheart rate during autonomous nervous system testing
Autonomic nervous system function-Heart rate variabilityinitial and 4 week evaluationheart rate variability during autonomous nervous system testing

Countries

Canada

Contacts

Primary ContactIsabelle Gagnon, PhD
isabelle.gagnon8@mcgill.ca514-412-4400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026