NCT07025616尚未招募不适用
Effectiveness of Buteyko Breathing Exercise in Children With Uncontrolled Asthma: A Single Blind, Randomized Controlled Trial
Ivan Sofian Wibowo1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年6月最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Asthma control
研究概览
简要总结
This randomized controlled trial study aimed to measure the effectiveness of the combination of 4-weeks Buteyko breathing exercises and pharmacological therapy compared with pharmacological therapy alone in children with uncontrolled asthma.
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7-17 years
- •Uncontrolled or partially controlled asthma (GINA Symptom Control Tool score > 1)
- •Receive bronchodilator therapy, either oral or inhaler from a pediatrician.
- •Children and parents/care givers agree to participate in the study until the end, and parents/care givers sign the informed consent form.
- •Can understand instructions.
排除标准
- •Have received Buteyko breathing exercises or other breathing exercises.
- •Have congenital heart disease, pneumonia, or other significant and uncontrolled health disorders.
- •Have severe physical disabilities or mental retardation that could potentially prevent the implementation of Buteyko breathing exercises.
- •Have contraindications for spirometry examination
研究组 & 干预措施
Buteyko
Experimental
Buteyko breathing exercise plus pharmacological treatment
干预措施: Buteyko (Behavioral)
Buteyko
Experimental
Buteyko breathing exercise plus pharmacological treatment
干预措施: Asthma reliever and controller (Drug)
Control
Active Comparator
Pharmacological treatment
干预措施: Asthma reliever and controller (Drug)
结局指标
主要结局
Asthma control
时间窗: At enrollment and end of fourth-week
Level of asthma control measured by Asthma Control Questionnaire (ACQ) - Indonesian version. Minimum value 0, maximum value 6. Higher score means worse outcome.
次要结局
- Asthma Quality of Life(At enrollment and end of fourth-week)
- Bronchodilator use(At end of fourth-week)
- FEV1(At enrollment and end of fourth-week)
- FVC(At enrollment and end of fourth-week)
- FEV1/FVC(At enrollment and end of fourth-week)
- PEFR(At enrollment and end of fourth-week)
- Control Pause(At enrollment and end of fourth-week)
研究者
Ivan Sofian Wibowo
dr.
Indonesia University
研究点 (1)
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