Recruiting

Paced Breathing

Sponsor:

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

Code:

NCT06559865

Conditions

Concussion, Mild

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

Interventions

Breathing exercises

Study Details

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.

Conditions

Concussion, Mild

Study ID

NCT06559865

Start date

Jun 1, 2024

Status verified date

Sep, 2024

Completion date

Dec 15, 2024

Anticipated

Primary completion date

Dec 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Breathing exercises

In addition to the standard rehabilitation care in the concussion clinic, the intervention group will have a daily 10-minutes paced breathing home-exercise program. The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.

no intervention: Usual care

Treatment for a concussion involves relative physical and cognitive rest for 24-48 hs, then a focus on gradually returning to normal activities and school as symptoms improve. Follow-up with healthcare professionals in the concussion clinic to ensure a safe and effective recovery and full return to school and sport. The concussion clinic follow-up includes meeting with a coordinator and physical therapist, and with a psychologist or MD if necessary

Interventions

Breathing exercises

as per group description

Primary outcome measure

  • Feasibility-days of practice [ Time Frame: 4 weeks ]
  • Feasibility-daily duration of practice [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Isabelle Gagnon, PhD

514-412-4400isabelle.gagnon8@mcgill.ca

Locations

McGill University Health Center

Recruiting

Montréal, Quebec, Canada, H4A 3S5

Contacts

Isabelle Gagnon

5144124400isabelle.gagnon8@mcgill.ca

More Information

Sponsor

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

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-10-01.