Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Interstitial Lung Disease (ILD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Work Rate (in watts)
研究概览
简要总结
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with interstitial lung disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •interstitial lung disease, diagnosed by high-resolution CT
- •FEV1/FVC >70% and FVC <85% predicted
- •stable medication for at least 4 weeks
- •Desaturation in SpO2 in 6-minute walk test of ≥ 4% to absolute values ≤ 92%
- •Signed Informed Consent
- •Male and female patients 18 to 80 years of age
排除标准
- •Severe daytime hypoxemia (PaO2 ≤7.3 or <55 mmHg at rest)
- •Other clinically significant concomitant disease states (e.g., cardiovascular disease, hepatic dysfunction, etc)
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, neurological or orthopaedic problems with walking disability or inability to ride a bicycle
- •Women who are pregnant or breast feeding
研究组 & 干预措施
Oxygen
Supplemental oxygen will be applied via a mask during CPET
干预措施: Incremental exercise test (IET) (Procedure)
Oxygen
Supplemental oxygen will be applied via a mask during CPET
干预措施: Constant work rate exercise test (CWRET) (Procedure)
Air
Sham ambient air will be applied via mask during CPET
干预措施: Incremental exercise test (IET) (Procedure)
Air
Sham ambient air will be applied via mask during CPET
干预措施: Constant work rate exercise test (CWRET) (Procedure)
结局指标
主要结局
Work Rate (in watts)
时间窗: 1 day
Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
Endurance time (in seconds)
时间窗: 1 day
Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests
次要结局
- Changes in breathing patterns: Oxygen uptake (VO2)(1 day)
- Changes in arterial blood: pondus Hydrogenii (pH) values(1 day)
- Changes in arterial blood: Bicarbonate (HCO3)(1 day)
- changes in physiological vital signs: Heart rate (hr)(1 day)
- Changes in breathing patterns: Carbon dioxide output (VCO2)(1 day)
- Changes in breathing patterns: Breathing equivalent for O2 (VE/VO2)(1 day)
- Changes in breathing patterns: Breathing equivalent for O2 (VE/VCO2)(1 day)
- Changes in breathing patterns: VE/VCO2Slope(1 day)
- Changes in breathing patterns: Ventilatory threshold one (Vt1)(1 day)
- Changes in breathing patterns: Minute ventilation (VE)(1 day)
- Changes breathing patterns: Tidal volume (Vt)(1 day)
- changes in physiological vital signs: Blood pressure(1 day)
- Changes in arterial blood: arterial partial pressure of CO2 (PaCO2)(1 day)
- Changes in breathing patterns: Ventilatory threshold two (Vt2)(1 day)
- Changes in arterial blood: arterial partial pressure of O2 (PaO2)(1 day)
- Changes in arterial blood: arterial lactate concentration(1 day)
- Changes in tissue oxygenation: Cerebral tissue oxygenation (CTO, measured at the forehead)(1 day)
- Changes in tissue oxygenation: Pulse oxymetrie (SpO2, measured at the finger)(1 day)
- Changes in tissue oxygenation: Muscle tissue oxygenation (MTO, measured at the quadriceps muscle)(1 day)