Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase) (Breathe - PED)
2026년 5월 7일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Isabelle Gagnon, PhD
- 전화번호: 23896 514-412-4400
- 이메일: isabelle.gagnon8@mcgill.ca
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H4A 3J1
- 모병
- Montreal Children's Hospital
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연락하다:
- Isabelle Gagnon, PhD
- 전화번호: 23896 514-412-4400
- 이메일: isabelle.gagnon8@mcgill.ca
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연락하다:
- Joanna Mazza
- 이메일: joanna.mazza@muhc.mcgill.ca
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility-days of practice
기간: 4 weeks
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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
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Document autonomic nervous system related symptoms before and after administration of the intervention using the modified Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire.
기간: 4 weeks
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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
기간: 4 weeks
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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.
기간: 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.
기간: 4 weeks
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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.
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 1일
기본 완료 (추정된)
2027년 5월 30일
연구 완료 (추정된)
2027년 5월 30일
연구 등록 날짜
최초 제출
2026년 5월 1일
QC 기준을 충족하는 최초 제출
2026년 5월 1일
처음 게시됨 (실제)
2026년 5월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 7일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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