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

McGill University

Status: Enrolling

Conditions: Concussion, Mild

Treatments: Behavioral: Breathing exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06559865

2024-10503

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Breathing exercises

Experimental group

Description:

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.

Treatment:

Behavioral: Breathing exercises

Usual care

No Intervention group

Description:

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