Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility-days of practice
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •known heart disease,
- •previous neurological problems other than concussion
结局指标
主要结局
Feasibility-days of practice
时间窗: 4 weeks
number of days children in the experimental group will engage in performing their breathing exercises
Feasibility-daily duration of practice
时间窗: 4 weeks
number of minutes children in the experimental group will engage in performing their breathing exercises
次要结局
- Autonomic nervous system function-Heart rate(initial and 4 week evaluation)
- Autonomic nervous system function-Heart rate variability(initial and 4 week evaluation)
研究者
Isabelle Gagnon
Senior Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre