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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Concussion, Mild
• Intervention / Treatment: Behavioral: Breathing exercises

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Gagnon, PhD; Phone Number: 23896 514-412-4400; Email: isabelle.gagnon8@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3S5
      • Recruiting
      • McGill University Health Center
      • Contact: Isabelle Gagnon; Phone Number: 5144124400; Email: isabelle.gagnon8@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breathing exercises; In addition to the standard rehabilitation care in the concussion clinic, the intervention group will have a daily 10-minutes paced breathing home-exercise program. The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.	Behavioral: Breathing exercises; as per group description
No Intervention: Usual care; Treatment for a concussion involves relative physical and cognitive rest for 24-48 hs, then a focus on gradually returning to normal activities and school as symptoms improve. Follow-up with healthcare professionals in the concussion clinic to ensure a safe and effective recovery and full return to school and sport. The concussion clinic follow-up includes meeting with a coordinator and physical therapist, and with a psychologist or MD if necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility-days of practice	number of days children in the experimental group will engage in performing their breathing exercises	4 weeks
Feasibility-daily duration of practice	number of minutes children in the experimental group will engage in performing their breathing exercises	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomic nervous system function-Heart rate	heart rate during autonomous nervous system testing	initial and 4 week evaluation
Autonomic nervous system function-Heart rate variability	heart rate variability during autonomous nervous system testing	initial and 4 week evaluation

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 2024-10503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No