About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
known heart disease,
previous neurological problems other than concussion
Trial design
Parallel
Treatments tested in this trial
Breathing exercises
Behavioralas per group description
Treatment groups
Trial outcomes
Primary outcomes
Feasibility-days of practice
number of days children in the experimental group will engage in performing their breathing exercises
Feasibility-daily duration of practice
number of minutes children in the experimental group will engage in performing their breathing exercises
Secondary outcomes
Autonomic nervous system function-Heart rate
heart rate during autonomous nervous system testing
Autonomic nervous system function-Heart rate variability
heart rate variability during autonomous nervous system testing
Sponsors and contacts
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