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
- 60
- 试验地点
- 1
- 主要终点
- Constant Work Rate Endurance Time (CWRET)
研究概览
简要总结
Although uncommon, interstitial lung diseases (ILDs), and particularly idiopathic pulmonary fibrosis (IPF), are progressive, irreversible, and ultimately fatal without treatment. Pharmacological therapies can slow the decline in forced vital capacity (FVC) and six-minute walk distance (6MWD), but they do not improve exercise-related respiratory limitations or quality of life.
Therefore, pulmonary rehabilitation (PR) is recommended for patients with a confirmed diagnosis of ILD/IPF who experience exercise limitation and significant functional impairment. However, the benefits of PR remain modest, and the optimal rehabilitation strategies for these patients have yet to be defined, particularly given the severe dyspnea and often profound exertional hypoxemia that characterize the disease.
To optimize the effects of PR, especially exercise training, the use of high-flow nasal oxygen (HFNO) during exercise has been proposed in certain respiratory conditions such as chronic obstructive pulmonary disease (COPD). By improving oxygenation and exercise tolerance, HFNO applied during exercise training sessions may enhance the effectiveness of pulmonary rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥18 years.
- •Confirmed diagnosis of interstitial lung disease (ILD).
- •Indication for pulmonary rehabilitation according to current guidelines, defined as exercise limitation associated with significant functional impairment.
- •Clinically stable disease with no recent exacerbation requiring treatment modification within the previous 3 months.
- •Affiliation with a health insurance/social security system.
- •Ability to understand the study procedures and provide written informed consent.
- •Non-inclusion Criteria:
- •Inability to perform cycle ergometer exercise testing.
- •Participation in a pulmonary rehabilitation program within the previous 6 months.
- •Any contraindication to exercise testing according to standard clinical practice.
- •Inability to provide informed consent.
- •Current participation in another interventional study during an exclusion period.
- •Pregnant or breastfeeding women.
- •Individuals deprived of liberty by judicial or administrative decision.
- •Adults under legal protection or guardianship.
排除标准
- 未提供
结局指标
主要结局
Constant Work Rate Endurance Time (CWRET)
时间窗: Baseline and end of the 4-week PR program.
Endurance time measured during a constant-load exercise test performed at 70% of peak work rate (PWR) in room air determined during baseline incremental cardiopulmonary exercise testing.
次要结局
- Six-Minute Walk Distance(Baseline and end of the 4-week pulmonary rehabilitation.)
- Dyspnea, Leg Discomfort and Rate of Percieved Exertion (RPE)(Dyspnea and Leg Discomfort : during constant-load exercise test and 6-min walk test, at baseline and end of 4-week PR. Dyspnea and RPE : during each of the 20 exercise training sessions on a bicycle ergometer.)
- Pulmonary responses to exercise(Baseline and end of the 4-week pulmonary rehabilitation.)
- Oxygen saturation(During each of the 20 exercise training sessions on a bicycle ergometer.)
- Heart Rate(Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.)
- Power(During each of the 20 exercise training sessions on a bicycle ergometer. During the CPET, baseline and end of the 4-week pulmonary rehabilitation)
- Near Infrared Spetroscopy(Baseline and end of the 4-week PR)
- King's Brief Interstitial Lung Disease (K-BILD)(Baseline and end of the 4-week pulmonary rehabilitation)
- modified Medical Research Council (mMRC)(Baseline and end of the 4-week pulmonary rehabilitation)
- Hospital Anxiety and Depression Scale (HADS)(Baseline and end of the 4-week pulmonary rehabilitation)
- Pichot Fatigue Scale(Baseline and end of the 4-week pulmonary rehabilitation)
研究者
Frédéric Hérengt
MD
Dieulefit Santé Centre de Réadaptation