Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Maximal Inspiratory Mouth Pressure (MIP)
研究概览
简要总结
This is a pilot study which will assess the feasibility of a follow on main study. This study will examine the impact of inspiratory muscle training on quality of life, rescue drug medication usage, and other markers of asthma in adult asthmatics in the UK.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma Control Questionnaire score of ≥ 1.5
- •10 mg or less of prednisolone (or equivalent) daily
- •Aged 18 to 59 years inclusive
- •Able to provide written informed consent
排除标准
- •Any significant heart or lung disease other than asthma including any previous history of pneumothorax
- •Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease) not controlled with treatment, making implementation of the protocol or interpretation of the study results difficult
- •Women who are pregnant
- •Forced expiratory volume in one second of less than 50% best or predicted
- •A history of smoking 20 cigarettes a day for 20 years or more (or an equivalent amount)
- •Undertaken a structured program of inspiratory muscle training within the past three months
- •Currently a participant in another interventional study
研究组 & 干预措施
Experimental
6 weeks of inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to up to 50% of pre-training maximal inspiratory mouth pressure and will be adapted weekly to reflect the improvement in inspiratory muscle strength
干预措施: inspiratory muscle training (Other)
Sham Comparator
6 weeks of sham inspiratory muscle training, 6 days per week. The intensity of training will be equivalent to 5% of pre-training inspiratory mouth pressure throughout the 6 week period.
干预措施: inspiratory muscle training (Other)
结局指标
主要结局
Maximal Inspiratory Mouth Pressure (MIP)
时间窗: pre (after the 4 week run-in) and post 6 weeks of IMT
MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).
次要结局
未报告次要终点
研究者
Mitch Lomax
Senior Lecturer
University of Portsmouth