Nasal High-flow Oxygen Therapy During Rehabilitive Exercise Training in ILD (PID-OX)
2026年6月25日 更新者：Frédéric Hérengt
Does Nasal High-Flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?
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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Auvergne-Rhône-Alpes
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Dieulefit、Auvergne-Rhône-Alpes、法国、26220
- Association Dieulefit Santé
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Nasal high-flow oxygen therapy
Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50)
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Participants will undergo a standardized 4-week pulmonary rehabilitation program consisting of respiratory therapy exercises (20min), cycle ergometer endurance training, outdoor walking, calisthenics, and muscle strengthening exercises, performed 5 days per week for a total of 20 sessions.
During cycle ergometer endurance training, participants will receive NHFO2.
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有源比较器：Conventional oxygen therapy
Conventional oxygen therapy (nasal canula; flow= 4-9 L/min; inspired fraction of O2= 1.0)
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Participants will undergo a standardized 4-week pulmonary rehabilitation program consisting of respiratory therapy exercises (20min), cycle ergometer endurance training, outdoor walking, calisthenics, and muscle strengthening exercises, performed 5 days per week for a total of 20 sessions.
During cycle ergometer endurance training, participants will receive conventional O2 therapy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Constant Work Rate Endurance Time (CWRET)
大体时间：Baseline and end of the 4-week PR program.
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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.
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Baseline and end of the 4-week PR program.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Six-Minute Walk Distance
大体时间：Baseline and end of the 4-week pulmonary rehabilitation.
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Distance walked during the 6-Minute Walk Test.
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Baseline and end of the 4-week pulmonary rehabilitation.
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Dyspnea, Leg Discomfort and Rate of Percieved Exertion (RPE)
大体时间：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.
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Using the modified CR10 Borg scale (ranging from 0 [nothing at all] to 10 [maximal]) for dyspnea and leg discomfort; using the 6 (no exertion at all) - 20 (maximum exertion) Borg scale for RPE.
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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.
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Pulmonary responses to exercise
大体时间：Baseline and end of the 4-week pulmonary rehabilitation.
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Pulmonary exercise parameters, including ventilation (VE, L/min), gas exchange (VO2, VCO2, L/min), assessed during a cardiopulmonary exercise test (CPET) and during constant-load cycle ergometer endurance tests.
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Baseline and end of the 4-week pulmonary rehabilitation.
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Oxygen saturation
大体时间：During each of the 20 exercise training sessions on a bicycle ergometer.
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By pulse oximetry
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During each of the 20 exercise training sessions on a bicycle ergometer.
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Heart Rate
大体时间：Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.
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Using electrocardiogram, in beats/min
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Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.
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Power
大体时间：During each of the 20 exercise training sessions on a bicycle ergometer. During the CPET, baseline and end of the 4-week pulmonary rehabilitation
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During each of the 20 exercise training sessions on a bicycle ergometer. During the CPET, baseline and end of the 4-week pulmonary rehabilitation
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Near Infrared Spetroscopy
大体时间：Baseline and end of the 4-week PR
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Of the Vastus Lateralis, used during the CPET and CWRET.
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Baseline and end of the 4-week PR
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King's Brief Interstitial Lung Disease (K-BILD)
大体时间：Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (worst) to 100 (better)
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Baseline and end of the 4-week pulmonary rehabilitation
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modified Medical Research Council (mMRC)
大体时间：Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 4 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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Hospital Anxiety and Depression Scale (HADS)
大体时间：Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 21 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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Pichot Fatigue Scale
大体时间：Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 32 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Dowman L, Hill CJ, May A, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2021 Feb 1;2(2):CD006322. doi: 10.1002/14651858.CD006322.pub4.
- Rochester CL, Alison JA, Carlin B, Jenkins AR, Cox NS, Bauldoff G, Bhatt SP, Bourbeau J, Burtin C, Camp PG, Cascino TM, Dorney Koppel GA, Garvey C, Goldstein R, Harris D, Houchen-Wolloff L, Limberg T, Lindenauer PK, Moy ML, Ryerson CJ, Singh SJ, Steiner M, Tappan RS, Yohannes AM, Holland AE. Pulmonary Rehabilitation for Adults with Chronic Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2023 Aug 15;208(4):e7-e26. doi: 10.1164/rccm.202306-1066ST.
- Al Chikhanie Y, Veale D, Verges S, Herengt F. The effect of heated humidified nasal high flow oxygen supply on exercise tolerance in patients with interstitial lung disease: A pilot study. Respir Med. 2021 Sep;186:106523. doi: 10.1016/j.rmed.2021.106523. Epub 2021 Jun 29.
- Kozu R, Senjyu H, Jenkins SC, Mukae H, Sakamoto N, Kohno S. Differences in response to pulmonary rehabilitation in idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease. Respiration. 2011;81(3):196-205. doi: 10.1159/000315475. Epub 2010 May 27.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年8月1日
初级完成 (实际的)
2025年5月31日
研究完成 (实际的)
2025年5月31日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月25日
首次发布 (实际的)
2026年7月1日
研究记录更新
最后更新发布 (实际的)
2026年7月1日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.