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NCT Number: NCT06559865

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

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.

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Center

Montreal, Quebec, H4A 3S5, Canada

Location status: Recruiting

Location contact

Isabelle Gagnon

CONTACT

[email protected]

5144124400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breathing exercises

Behavioral

as per group description

Primary outcomes

  1. Feasibility-days of practice

    Time frame: 4 weeks

    number of days children in the experimental group will engage in performing their breathing exercises

  2. Feasibility-daily duration of practice

    Time frame: 4 weeks

    number of minutes children in the experimental group will engage in performing their breathing exercises

Secondary outcomes

  1. Autonomic nervous system function-Heart rate

    Time frame: initial and 4 week evaluation

    heart rate during autonomous nervous system testing

  2. Autonomic nervous system function-Heart rate variability

    Time frame: initial and 4 week evaluation

    heart rate variability during autonomous nervous system testing

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Gagnon, PhD

CONTACT

[email protected]

514-412-4400 ext. 23896

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: Breathe

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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