Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breathing exercises.
- Who it may be relevant to
- Registry conditions: Concussion, Mild. Basic parameters: 9 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study
Overview
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.
Interventions
- Behavioral Breathing exercises
as per group description
Primary outcome measures
- Feasibility-days of practice [Time frame: 4 weeks]
- Feasibility-daily duration of practice [Time frame: 4 weeks]
Secondary outcome measures (2)
- Autonomic nervous system function-Heart rate [Time frame: initial and 4 week evaluation]
- Autonomic nervous system function-Heart rate variability [Time frame: initial and 4 week evaluation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McGill University Health Center — Montreal
Identifiers
NCT: NCT06559865 · 2024-10503