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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Feasibility-days of practice [Срок оценки: 4 weeks]
• Feasibility-daily duration of practice [Срок оценки: 4 weeks]

Вторичные конечные точки (5)

• Document autonomic nervous system related symptoms before and after administration of the intervention using the modified Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 4 weeks]
• Document post-concussion symptoms before and after administration of the intervention using the Post-Concussion Symptom Inventory for Children (PSCI-C) questionnaire. [Срок оценки: 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. [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Montreal Children's Hospital — Montreal

Идентификаторы

NCT: NCT07572734 · 2024-10503-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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