Does Nasal High-flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Time to exercise intolerance
研究概览
简要总结
Hallmarks of fibrotic interstitial lung disease (f-ILD) include severe hypoxemia, dyspnea and exercise limitation. Although ambulatory oxygen (O2) therapy is widely prescribed, standard low-flow O2 systems (nasal prongs) fail to meet patients' inspiratory demand on exertion resulting in incomplete correction of hypoxemia and limited symptomatic relief. Nasal high-flow O2 therapy (NHFO2) delivers heated, humidified, and O2-enriched air at high flow rates. It has recently emerged as a promising alternative to overcome the pre-specified limitations: NHFO2 is more effective in correcting hypoxemia and reducing dyspnea vs standard O2 therapy and consistently improved exercise capacity in f-ILD. In fact, NHF per se may exert independent physiological benefits such as washout of the anatomical dead space and reduced work of breathing. However, the respective effect of respiratory support and improved oxygenation on dyspnea and exercise tolerance remain unexplored in f-ILD. To address this gap in knowledge, this prospective, randomized-controlled trial aimed to disentangle the i) independent and ii) combined effects of respiratory support and supplemental O2 on dyspnea and exercise tolerance in patients with f-ILD.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of fibrotic interstitial lung disease (regardless of etiology)
- •age ≥18 years
- •modified Medical Research Council scale ≥1
- •stable condition (no acute exacerbation within the preceding 3 months)
排除标准
- •inability to perform a cardiopulmonary exercise test (CPET) on a bicycle ergometer
- •participation in a pulmonary rehabilitation program within the last 6 months
研究组 & 干预措施
Room Air
Room Air breathing (flow= 0 L/min; inspired fraction of O2= 0.21)
干预措施: Exercise testing (Other)
Supplemental Oxygen
Supplemental oxygen therapy (flow= 9-12 L/min; inspired fraction of O2= 1.0)
干预措施: Exercise testing (Other)
Nasal high-flow
Nasal high-flow (flow= 50-70 L/min; inspired fraction of O2= 0.21)
干预措施: Exercise testing (Other)
Nasal high-flow oxygen therapy
Nasal high-flow oxygen therapy (flow= 50-70 L/min; inspired fraction of O2= 0.50)
干预措施: Exercise testing (Other)
结局指标
主要结局
Time to exercise intolerance
时间窗: 4 times over 2 consecutive days (1 time per experimental condition)
Measured during a constant work-rate exercise test (70% peak work rate)
Isotime dyspnea
时间窗: 4 times over 2 consecutive days (1 time per experimental condition)
0-10 category-ratio Borg scale
次要结局
- Breathing pattern(4 times over 2 consecutive days (1 time per experimental condition))
- Gas exchange(4 times over 2 consecutive days (1 time per experimental condition))
- Quadriceps muscle oxygenation(4 times over 2 consecutive days (1 time per experimental condition))
研究者
Frédéric Hérengt
Principal Investigator
Dieulefit Santé Centre de Réadaptation
