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Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase) (Breathe - PED)

7 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

20

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: Paced breathing exercises
The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility-days of practice
Periodo de tiempo: 4 weeks
Number of days children in the experimental group will engage in performing their breathing exercises
4 weeks
Feasibility-daily duration of practice
Periodo de tiempo: 4 weeks
Number of minutes children in the experimental group will engage in performing their breathing exercises
4 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Document autonomic nervous system related symptoms before and after administration of the intervention using the modified Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire.
Periodo de tiempo: 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
4 weeks
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
Periodo de tiempo: 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.
4 weeks
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.
Periodo de tiempo: 4 weeks
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.
4 weeks
Document post-concussion symptoms before and after administration of the intervention using the Post-Concussion Symptom Inventory for Children (PSCI-C) questionnaire.
Periodo de tiempo: 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.
4 weeks
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.
Periodo de tiempo: 4 weeks
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.
4 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2026

Finalización primaria (Estimado)

30 de mayo de 2027

Finalización del estudio (Estimado)

30 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de mayo de 2026

Publicado por primera vez (Actual)

7 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2024-10503-2

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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