Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase) (Breathe - PED)
7. Mai 2026 aktualisiert von: Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study
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 acute period after concussion. Secondary objectives include documenting symptom severity (ANS related symptoms, post-concussion symptoms, anxiety, sleep) before and after administration of the intervention and examine whether early paced-breathing exercise can accelerate recovery and symptom improvement.
Participants 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 the Pediatric Emergency Department. A weekly phone meeting will be performed with all participants to assess recovery progress. Participants randomized to the intervention group will also be asked about their exercises, will be provided specific instructions and adjustments as necessary. 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.
Studienübersicht
Status
Rekrutierung
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
20
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Isabelle Gagnon, PhD
- Telefonnummer: 23896 514-412-4400
- E-Mail: isabelle.gagnon8@mcgill.ca
Studienorte
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Quebec
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Montreal, Quebec, Kanada, H4A 3J1
- Rekrutierung
- Montreal Children's Hospital
-
Kontakt:
- Isabelle Gagnon, PhD
- Telefonnummer: 23896 514-412-4400
- E-Mail: isabelle.gagnon8@mcgill.ca
-
Kontakt:
- Joanna Mazza
- E-Mail: joanna.mazza@muhc.mcgill.ca
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Aged 9-18 years old
- 0-72 hours post-concussion
- present to the ED with 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Breathing exercises
In addition to the standard care in the Pediatric Emergency Department, 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.
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The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.
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Kein Eingriff: Usual Care
Treatment for a concussion involves relative physical and cognitive rest for 24-48 hours, followed by gradually returning to normal activities and school as symptoms improve.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility-days of practice
Zeitfenster: 4 weeks
|
Number of days children in the experimental group will engage in performing their breathing exercises
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4 weeks
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Feasibility-daily duration of practice
Zeitfenster: 4 weeks
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Number of minutes children in the experimental group will engage in performing their breathing exercises
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4 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Document autonomic nervous system related symptoms before and after administration of the intervention using the modified Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire.
Zeitfenster: 4 weeks
|
The COMPASS-31 is a self-reported questionnaire that investigates the presence of 31 symptoms in six ANS domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor.
Respondents report symptoms on a dichotomous (yes/no) and on Likert- like scales to indicate aspects such as frequency, severity, and changes in the symptoms.
The subscales are then scored according to a weighted formula, and sum to a total COMPASS-31 score out of 100 where higher scores indicate more severe ANS symptoms
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4 weeks
|
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Document changes in anxiety before and after administration of the intervention using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Pediatric Anxiety- Short Form 8a
Zeitfenster: 4 weeks
|
PROMIS anxiety assesses emotional, cognitive, and physical symptoms of anxiety in children and adolescents; higher scores indicate greater impairment where scores of 8-15 indicate minimal anxiety symptoms, 16-21 indicate mild anxiety symptoms, 22-32 indicate moderate anxiety symptoms, 33-40 severe anxiety symptoms.
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4 weeks
|
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Document changes in sleep before and after administration of the intervention using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Pediatric Sleep-Related Impairment and Sleep Disturbance- Short Forms 4a.
Zeitfenster: 4 weeks
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PROMIS sleep questionnaires are scored by summing responses to 4 questions, scores ranging from 4 to 20.
Raw scores are converted to a standardized T-score via conversion tables, with higher t-scores indicating worse sleep quality.
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4 weeks
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Document post-concussion symptoms before and after administration of the intervention using the Post-Concussion Symptom Inventory for Children (PSCI-C) questionnaire.
Zeitfenster: 4 weeks
|
The PCSI-C is a symptom scale with age-based versions.
For the purpose of this study 2 age-based versions will be used, 8-12 and 13-18.
The ages 8-12 version is a 17-items, 3-point Guttman Scale (0-2), and the ages 13-18, is a 20-items, 7-point Guttman Scale (0-6).
Participants are asked to rate their current PCS in reference to the day of assessment and/or the previous day and retrospectively rate their symptoms prior to injury.
The total PCS change score (current PCS minus retrospective pre-injury symptoms; delta PCSI-P) will be used, with higher scores (range: 0-120) indicating more severe symptomatology.
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4 weeks
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Examine whether early paced-breathing exercise can accelerate recovery and symptom improvement (ANS-related symptoms, PCS, sleep and anxiety), and reduce the risk of persistent post-concussive symptoms.
Zeitfenster: 4 weeks
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Recovery- differences between groups in the time to fully return to school, return to sport and medication clearance.
Symptoms improvement- measures described above will be compared within each group and between groups.
Reduce the risk of persistent post-concussive symptoms- measures described above will be compared within each group and between groups in addition to the number of treatments and/or the need for specialized concussion care.
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4 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Mai 2026
Primärer Abschluss (Geschätzt)
30. Mai 2027
Studienabschluss (Geschätzt)
30. Mai 2027
Studienanmeldedaten
Zuerst eingereicht
1. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Mai 2026
Zuerst gepostet (Tatsächlich)
7. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
7. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2024-10503-2
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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