Actively Recruiting
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
Eligibility Criteria
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)
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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