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

Not Applicable

Recruiting

• Conditions: Concussion, Mild

• Registration Number: NCT06559865
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-19
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Autonomic nervous system function-Heart rate	initial and 4 week evaluation	heart rate during autonomous nervous system testing
Autonomic nervous system function-Heart rate variability	initial and 4 week evaluation	heart rate variability during autonomous nervous system testing

Trial Locations

Locations (1)

McGill University Health Center; 🇨🇦 Montréal, Quebec, Canada