McGill University Health Center
Montreal, Quebec, H4A 3S5, Canada
Location status: Recruiting
NCT Number: NCT06559865
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.
Interested in participating?
Request Info9 year–18 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H4A 3S5, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
as per group description
Time frame: 4 weeks
number of days children in the experimental group will engage in performing their breathing exercises
Time frame: 4 weeks
number of minutes children in the experimental group will engage in performing their breathing exercises
Time frame: initial and 4 week evaluation
heart rate during autonomous nervous system testing
Time frame: initial and 4 week evaluation
heart rate variability during autonomous nervous system testing
Contact information is provided by the study sponsor or research team.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
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
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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