NCT03911206已完成不适用
The Duke Healthy Breathing Study Stage 2 (DHBS): A Randomized Controlled Trial Assessing the Safety and Feasibility of Respiratory Muscle Training and Exercise Training in Children and Adolescents With Persistent Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of participants that complete respiratory muscle training (IMT) and exercise.
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of a 6-week Inspiratory Muscle Training and cardiovascular exercise training program in children and adolescents with asthma.
To also determine the efficacy of inspiratory muscle training and exercise in increasing respiratory muscle strength and endurance, and to explore relationships between fitness interventions (inspiratory muscle training and exercise), exercise tolerance, airway closure and dyspnea scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-17 years of age
- •Clinician-diagnosed asthma
- •Sedentary activity defined as having not participated in a sports team or formal activity (dance classes, gym membership, active hobby requiring physical activity) in the past 12 months or have a
- •Body mass index (BMI) ≥85th percentile (adjusted for sex and age)
- •Child must have a designated caregiver who expresses a commitment to encourage the participant to attend weekly clinic-based exercise and also complete additional home exercise.
排除标准
- •Previous intubation for asthma,
- •Forced expiratory volume in 1 second (FEV1) < 50% of predicted at enrollment;
- •Any major chronic illness that in the opinion of the PI would interfere with participation in the intervention or completion of the study procedures;
- •Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI
- •Currently active in sports, vigorous play or planned exercise more than 1 time per week on average over the past month
- •Current Pregnancy as determined by urine pregnancy test.
- •Parent/Caregiver unable to consent in English
结局指标
主要结局
Number of participants that complete respiratory muscle training (IMT) and exercise.
时间窗: 6 weeks
Percentage of Participant's with asthma and not participating in any physical activity
时间窗: 6 weeks
Number of Adverse events reported by participants.
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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