Actively Recruiting

Phase Not Applicable
Age: 9Years - 18Years
All Genders
ID06559865

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

Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2024-10-01

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of a paced breathing exercise program on children and adolescents aged 9 to 18 years who are in the sub-acute phase after a mild concussion. The study aims to assess the feasibility of administering this breathing exercise intervention and document changes in autonomic nervous system function and symptom severity, including post-concussion symptoms, anxiety, and sleep disturbances. This pilot feasibility study is sponsored by McGill University Health Centre and seeks to understand how this intervention might support recovery after concussion. Participants will be randomly assigned to one of two groups. The intervention group will perform a daily 10-minute paced breathing exercise at home, involving inhaling for 4 seconds and exhaling for 6 seconds, totaling 6 breaths per minute. The control group will receive usual care through a concussion follow-up program involving physical and cognitive rest followed by gradual return to activities, with professional support as needed. Weekly phone meetings will guide participants in the breathing exercises and adjust instructions as necessary. Both groups will have a follow-up assessment after four weeks. During the study, participants will complete daily logs recording their exercise practice. Researchers will assess autonomic function through heart rate and heart rate variability at the start and after four weeks. Symptom severity and recovery milestones such as return to school, return to sport, and medication clearance will also be recorded. This study will monitor feasibility by tracking days and duration of practice, with all participants evaluated for outcomes and safety over the four-week period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 9Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 9 to 18 years
  • Seven days to three months post-concussion
  • Have at least one post-concussion symptom relevant to autonomic nervous system dysfunction (dizziness, nausea, fatigue, confusion, anxiety, or sleep disturbances)
Not Eligible

You will not qualify if you...

  • Known heart disease
  • Previous neurological problems other than concussion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 4 weeks

Participants perform a daily 10-minute paced breathing home-exercise program for 4 weeks or receive usual care involving concussion clinic follow-up and rehabilitation.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

McGill University Health Center

Montreal, Quebec, Canada, H4A 3S5

Actively Recruiting

Loading map...

Research Team

I

Isabelle Gagnon, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Acceptance and Commitment Therapy Integrated Vestibular Reha...

Concussion, Mild

Actively Recruiting

2 locations

Randomized Controlled Trial of Targeted Treatment in Older A...

Concussion, Mild

Actively Recruiting

1 location

Eye Recovery Automation for Post Injury Dysfunction Using Vi...

Convergence Insufficiency

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here