Chronic Obstructive Pulmonary Disease (COPD) Monitoring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Correlation between EMG and BORG scale during rehabilitation exercise
研究概览
简要总结
The present feasibility study aims at assessing whether the EMG of respiratory muscles can serve as an objective marker of dyspnea in COPD patients.
The study aims also at evaluating the changes in physiological parameters (i.e., EMG, respiration rate, heart rate, temperature, and SpO2) occurring when simulating daily activities before, during and after acute exacerbations. All this information can be useful to detect the exacerbations earlier or to provide better treatment during the exacerbations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have a clinical diagnosis of COPD
- •mMRC (Modified Medical Research Council) Dyspnea Scale Score > 1
- •Subject must be indicated for regular inpatient pulmonary rehabilitation
- •Subject must be hyperinflated, defined as residual volume (RV)>120% of the predicted value, measured by whole body plethysmography
- •Subject must be willing to provide Informed Consent for their participation in the study
- •Subject must be ≥18 years of age
排除标准
- •Subjects who are unable/unwilling to voluntarily participate in the study
- •Subjects who cannot read/write
- •Subjects who are dependent on oxygen and/or unfit to wear a mask during sub- maximal constant work rate test (CWRT)
- •Subject has congenital heart disease
- •Subject has unstable coronary artery disease
- •Subject has an active implanted cardiac device (i.e. IPG, ICD)
- •Subject has heart failure NYHA 4
- •Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study
- •Subject is legally incompetent
- •Subject is pregnant or has suspect to be pregnant
- •Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager
- •BORG scale assessment is evaluated as unreliable due to patient's cognitive condition
结局指标
主要结局
Correlation between EMG and BORG scale during rehabilitation exercise
时间窗: through study completion, an average of 3 months
To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during rehabilitation exercise .
Correlation between EMG and BORG scale during sub-maximal constant work rate test (CWRT) exercise
时间窗: through study completion, an average of 3 months
To evaluate the correlation between EMG amplitude collected by means of the data logger system and BORG scale during sub-maximal CWRT exercise.
次要结局
- Respiration rate (Exacerbation symptoms assessment)(through study completion, an average of 3 months)
- BORG scale (Exacerbation symptoms assessment)(through study completion, an average of 3 months)
- Correlation between transcutaneous oxygen saturation and BORG scale(through study completion, an average of 3 months)
- EMG (Exacerbation symptoms assessment)(through study completion, an average of 3 months)
- Transcutaneous oxygen saturation (Exacerbation symptoms assessment)(through study completion, an average of 3 months)
- Correlation between respiration rate and BORG scale(through study completion, an average of 3 months)