Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Determine effect of increased device-guided breathing on health-related quality of life measures.
研究概览
简要总结
Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided breathing is a behavioral intervention that guides respiratory rates into a therapeutic range; prolongation of the expiratory phase improves hyperinflation, the most significant driver of dyspnea in this population. Device-guided breathing, has no known side-effects, and may represent a cost effective adjunctive treatment for dyspnea in severe COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or former cigarette smokers of at least 10 pack-years
- •Clinically significant dyspnea, as determined by a score of at least 2 on the Medical Research Council Dyspnea Score questionnaire (0-4), or through pulmonary function test results of a residual volume (RV) of > 150% predicted or an FEV1 of <65% predicted
- •Clinical diagnosis of chronic obstructive pulmonary disease
排除标准
- •Unable to use the slow-breathing device due to hearing impairment
- •Poor motivation or lack of interest in using the device
- •Pulmonary Rehabilitation ordered as a new therapy at the time of enrollment
结局指标
主要结局
Determine effect of increased device-guided breathing on health-related quality of life measures.
时间窗: 8 weeks
Pre and post device use measures of dyspnea, health-related quality of life, stress, adn self-efficacy for managing chronic disease will be obtained through self-administered questionnaires.
次要结局
- Evaluate effect of device-guided slow breathing on daily physical activity.(8 weeks)
研究者
Roberto P. Benzo
Principal Investigator
Mayo Clinic