Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion

NCT06559865 | Recruiting

• 1 other identifier: 2024-10503
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Feasibility-days of practice

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

  4 weeks

• Feasibility-daily duration of practice

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

  4 weeks

Secondary Outcomes (2)

• Autonomic nervous system function-Heart rate

  initial and 4 week evaluation

• Autonomic nervous system function-Heart rate variability

  initial and 4 week evaluation

Study Arms (2)

Breathing exercises

EXPERIMENTAL

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.

Behavioral: Breathing exercises

Usual care

NO INTERVENTION

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 BEHAVIORAL

as per group description

Breathing exercises

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• known heart disease,
• previous neurological problems other than concussion

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3S5, Canada

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Isabelle Gagnon, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: June 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)