Feasibility of Inspiratory Muscle Training in Patients With Chronic Hypercapnia and Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Completed training sessions
研究概览
简要总结
The overall objective of the study is to investigate the feasibility of home based inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and to examine the relationship between inspiratory muscle strength and carbon dioxide level.
详细描述
The development of chronic hypercapnia in patients with COPD indicates an imbalance of increased ventilatory work caused by hyperinflation and airway resistance and a decreased inspiratory muscle reserve, probably caused by diaphragm- dysfunction. The inspiratory muscle strength can be trained by a devise, which provides a resistance to inspiration.
This study will be conducted as an a feasibility study and will examine whether inspiratory muscle training with a Power Breathe device (K3) is possible over a 6 week period in patients with COPD and chronic hypercapnia (pCO2 > 6 kilo pascal).
IMT will be considered as feasible if 80% of the planned training sessions have been completed, and if the maximum inspiratory strength improves by an average of 10% from MIP and if patients do not experience any discomfort or increased dyspnea during training.
The training of the respiratory strength is carried out daily with an electronic handheld device (Power Breathe K3) and will consist of 2x30 inspirations per day with the resistance adjusted individually and progressively with a pressure of 30 - 50% of maximal inspiratory pressure. Training will take place in the home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the diagnosis COPD with FEV1 / FVC <0.70 and FEV1 <50%
- •Have elevated pCO2 in stable phase assessed by arterial blood gas with pCO2> 6 kPa
- •Have given informed consent
- •Can understand written and oral instructions
排除标准
- •Patients are included in other projects with impact on the carbon dioxide level, e.g. home noninvasive ventilation treatment
- •Patients using variable oxygenation rate that may affect the carbon dioxide level.
- •Unstable patients and at high risk of exacerbation during the investigation period
- •Hospitalized patient with COPD exacerbation during the intervention period
- •Patients with an expected need for change of COPD medication or oxygen supply equipment in the study period.
- •The participation in the study will be postponed if the patient is in a rehabilitation program
研究组 & 干预措施
IMT-feasibility
Single arm intervention
干预措施: IMT (Other)
结局指标
主要结局
Completed training sessions
时间窗: 6 weeks
Feasibility - if 80% of the planned training sessions have been completed
Experienced discomfort
时间窗: 6 weeks and during the training session
Feasibility - if the patients do not experience any discomfort or increased dyspnea during and after training
Changes i Pimax
时间窗: 6 weeks
Feasibility - if the maximum inspiratory strength measured in cmH2O improves by an average of 10 %
次要结局
- 6 minutes walking test(6 weeks)
- Changes in pCO2(6 weeks)
- CAT(6 week)
研究者
Linette Marie Kofod
Physiotherapist
Hvidovre University Hospital