Effects of Expiratory Muscle Training in Children With Asthma: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Respiratory Function Test
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the effectiveness of expiratory muscle training (EMT) as an adjunct to conventional chest physiotherapy in children with asthma. Respiratory muscle training has been shown to improve muscle strength, functional capacity, and symptom control in adults with asthma, but evidence in pediatric populations is limited, particularly regarding expiratory training. This study aims to determine whether adding EMT to standard physiotherapy enhances pulmonary function, respiratory muscle strength, asthma control, and functional capacity compared to chest physiotherapy alone. The main questions are: (1) Does EMT improve expiratory muscle strength and pulmonary function in children with asthma? (2) Does EMT contribute to better asthma control and overall physical performance? Participants will be randomly assigned to either conventional chest physiotherapy or chest physiotherapy plus EMT. Interventions will be delivered as a home-based, low-cost, feasible program, with training protocols standardized in terms of intensity, frequency, and duration.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8 and 18 years Clinically diagnosed with asthma Ability to walk, cooperate, and be clinically stable Willingness to participate in the study
排除标准
- •History of hospitalization within the last 4 weeks prior to enrollment Hospitalization during the exercise training program Presence of secondary conditions that may affect respiratory function (e.g., kyphoscoliosis) Currently participating in or having participated in a regular exercise training program within the past year
研究组 & 干预措施
Experimental group
Children in the experimental group will receive the same home-based chest physiotherapy program as the control group (8 weeks, 5 days per week, 30 minutes per day). In addition, they will perform expiratory muscle training (EMT) using a threshold device at 30% of their maximum expiratory pressure (MEP). EMT will be applied twice daily for 20 minutes, at least 5 days per week for 8 weeks. Resistance will be increased by 10% each week, adjusted according to tolerance and the presence of any complaints.
干预措施: Expiratory Muscle Training (Other)
Control group
Children in the control group will receive a home-based chest physiotherapy program for 8 weeks, 5 days per week, 30 minutes per day. The program will include breathing exercises, teaching of relaxation positions, cough training, breathing control strategies, and physical activity recommendations. In addition, participants will perform sham expiratory muscle training at the lowest fixed load, twice daily for 20 minutes, at least 5 days per week for 8 weeks.
干预措施: Home-based chest physiotherapy program (Other)
Experimental group
Children in the experimental group will receive the same home-based chest physiotherapy program as the control group (8 weeks, 5 days per week, 30 minutes per day). In addition, they will perform expiratory muscle training (EMT) using a threshold device at 30% of their maximum expiratory pressure (MEP). EMT will be applied twice daily for 20 minutes, at least 5 days per week for 8 weeks. Resistance will be increased by 10% each week, adjusted according to tolerance and the presence of any complaints.
干预措施: Home-based chest physiotherapy program (Other)
结局指标
主要结局
Respiratory Function Test
时间窗: 8 weeks
Change from baseline forced vital capacity (FVC) at 8 weeks.
Respiratory Muscle Strength
时间窗: 8 weeks
Change from baseline maximum inspiratory pressure (MIP) at 8 weeks.
Peripheral Muscle Strength
时间窗: 8 weeks
Change from baseline m. quadriceps strength at 8 weeks.
Functional Capacity
时间窗: 8 weeks
Change from baseline distance covered in six minute walk test at 8 weeks.
Peak Cough Flow
时间窗: 8 weeks
Change from baseline peak cough flow at 8 weeks.
次要结局
- Asthma Control(8 weeks)