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Clinical Trials/NCT06559865
NCT06559865
Recruiting
Not Applicable

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

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country20 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Concussion, Mild
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
20
Locations
1
Primary Endpoint
Feasibility-days of practice
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
December 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Isabelle Gagnon

Senior Scientist

McGill University Health Centre/Research Institute of the McGill University Health Centre

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

Outcomes

Primary Outcomes

Feasibility-days of practice

Time Frame: 4 weeks

number of days children in the experimental group will engage in performing their breathing exercises

Feasibility-daily duration of practice

Time Frame: 4 weeks

number of minutes children in the experimental group will engage in performing their breathing exercises

Secondary Outcomes

  • Autonomic nervous system function-Heart rate(initial and 4 week evaluation)
  • Autonomic nervous system function-Heart rate variability(initial and 4 week evaluation)

Study Sites (1)

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