The Rationale of Applying Inspiratory/Expiratory Muscle Training Within the Same Respiratory Cycle in Children With Bronchial Asthma: A Placebo-controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Inspiratory muscle strength
研究概览
简要总结
This study was designed to assess the effect of inspiratory and expiratory muscle training in the same cycle on respiratory muscle strength, pulmonary functions, perception of asthma symptoms in children with bronchial asthma. Fifty-one children with bronchial asthma were randomly allocated to the unloaded respiratory muscle training (Placebo training group; n = 17), inspiratory muscle training alone (inspiratory muscle training group; n = 17), or combined inspiratory and expiratory muscle training in the same cycle (combined training group; n = 17). All groups were assessed for respiratory muscle strength, pulmonary functions, and asthma symptoms.
详细描述
Fifty-one children with bronchial asthma were recruited from King Khalid Hospital, Al-Kharj, Saudi Arabia. The study included children who had a confirmed diagnosis of bronchial asthma according to the Global Initiative for Asthma guidelines, aged 12-18 years, identified as being stable cases, had a baseline percent-predicted value of the peak expiratory flow rate of 60-80%, sustained stale doses of medications in the past three months. Children who had unstable asthma or exacerbated asthma symptoms, history of thoracic surgery, or cardiopulmonary comorbidities were excluded.
Outcome measures
- Respiratory muscle strength: assessed by measuring the maximal inspiratory and expiratory pressure using an electronic respiratory pressure meter.
- Pulmonary function: The forced vital capacity (FVC), forced expiratory volume in the first second of expiration (FEV1), and FEV1/FVC ratio, were measured in a pulmonary function test through a spirometry analyzer.
- Control of asthma symptoms: Asthma symptoms were assessed using a translated version of the asthma control test.
All groups received the conventional respiratory re-training program, three times a week, for 12 weeks in succession. The placebo group additionally received unloaded respiratory muscle training, the inspiratory muscle training group received respiratory muscle training alone, and the combined group received combined inspiratory and expiratory muscle training in the same cycle. Interventions were conducted by a licensed physical therapist who had experience of more than 10 years of respiratory training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor was blinded to the treatment allocation
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of asthma according to Global Initiative of Asthma guidelines.
- •Age between 12 and 18 years.
- •Clinically stable asthma.
- •Stable doses of medications in the last three months
- •A percent-predicted value of the peak expiratory flow rate of 60-80%
- •No activity limitation due to asthma
排除标准
- •Unstable asthma
- •Exacerbation of asthma symptoms
- •History of thoracic surgery
- •Cognitive/behavioral problems
- •Cardiopulmonary co-morbidities
研究组 & 干预措施
Placebo group
This group received a conventional respiratory retraining program plus unloaded (placebo) respiratory muscle training
干预措施: Placebo respiratory muscle training (Other)
Inspiratory muscle training group
This group received a conventional respiratory retraining program plus inspiratory muscle training only
干预措施: Inspiratory muscle training (Other)
Combined training group
This group received a conventional respiratory retraining program plus inspiratory and expiratory muscle training in the same respiratory cycle.
干预措施: Combined inspiratory and expiratory muscle training (Other)
结局指标
主要结局
Inspiratory muscle strength
时间窗: 2 months
Inspiratory muscle strength was assessed by measuring the maximal inspiratory pressure (reflects the strength of the diaphragm and other inspiratory muscles) using an electronic respiratory pressure meter, according to the American Thoracic Society and European Respiratory Society standards. The highest value of three acceptable trials was documented and used for the subsequent analysis. The percent predicted maximal inspiratory pressure values (%) were calculated and used for statistical analysis.
Expiratory muscle strength
时间窗: 2 months
Expiratory muscle strength was assessed by measuring the maximal expiratory pressure (reflects the strength of the abdominal muscles and other expiratory muscles) using an electronic respiratory pressure meter, according to the American Thoracic Society and European Respiratory Society standards. The highest value of three acceptable trials was documented and used for the subsequent analysis. The percent predicted maximal inspiratory pressure values (%) were calculated and used for statistical analysis.
Forced vital capacity
时间窗: 2 months
Forced vital capacity, which is the amount of air that each participant was able to forcibly exhale from his/her lungs after taking the deepest breath they can, was measured in a pulmonary function test with a spirometry analyzer and expressed as a percentage of predicted values (%). Three trials were allowed and the best results were recorded.
Forced expiratory volume in one second
时间窗: 2 months
Forced expiratory volume in one second, which is the volume of air exhaled in the first second during forced exhalation after a maximal inspiration, was measured in a pulmonary function test with a spirometry analyzer and expressed as a percentage of predicted values (%). Three trials were allowed and the best results were recorded.
Forced expiratory volume in one second / forced vital capacity
时间窗: 2 months
Forced expiratory volume in one second / forced vital capacity, is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
次要结局
- Asthma symptoms(2 months)
研究者
Ragab Kamal Elnaggar
Associate Professor
Cairo University