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Nasal High-flow Oxygen Therapy During Rehabilitive Exercise Training in ILD (PID-OX)

25 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • France
    • Auvergne-Rhône-Alpes
      • Dieulefit, Auvergne-Rhône-Alpes, France, 26220
        • Association Dieulefit Santé

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Nasal high-flow oxygen therapy
Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50)
Autre: Pulmonary rehabilitation with NHFO2
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.
Comparateur actif: Conventional oxygen therapy
Conventional oxygen therapy (nasal canula; flow= 4-9 L/min; inspired fraction of O2= 1.0)
Autre: Pulmonary rehabiltation with conventional oxygen therapy
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Constant Work Rate Endurance Time (CWRET)
Délai: 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.
Baseline and end of the 4-week PR program.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Six-Minute Walk Distance
Délai: Baseline and end of the 4-week pulmonary rehabilitation.
Distance walked during the 6-Minute Walk Test.
Baseline and end of the 4-week pulmonary rehabilitation.
Dyspnea, Leg Discomfort and Rate of Percieved Exertion (RPE)
Délai: 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.
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.
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
Délai: Baseline and end of the 4-week pulmonary rehabilitation.
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.
Baseline and end of the 4-week pulmonary rehabilitation.
Oxygen saturation
Délai: During each of the 20 exercise training sessions on a bicycle ergometer.
By pulse oximetry
During each of the 20 exercise training sessions on a bicycle ergometer.
Heart Rate
Délai: Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.
Using electrocardiogram, in beats/min
Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.
Power
Délai: During each of the 20 exercise training sessions on a bicycle ergometer. During the CPET, baseline and end of the 4-week pulmonary rehabilitation
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
Délai: Baseline and end of the 4-week PR
Of the Vastus Lateralis, used during the CPET and CWRET.
Baseline and end of the 4-week PR
King's Brief Interstitial Lung Disease (K-BILD)
Délai: Baseline and end of the 4-week pulmonary rehabilitation
Ranging from 0 (worst) to 100 (better)
Baseline and end of the 4-week pulmonary rehabilitation
modified Medical Research Council (mMRC)
Délai: Baseline and end of the 4-week pulmonary rehabilitation
Ranging from 0 (better) to 4 (worst)
Baseline and end of the 4-week pulmonary rehabilitation
Hospital Anxiety and Depression Scale (HADS)
Délai: Baseline and end of the 4-week pulmonary rehabilitation
Ranging from 0 (better) to 21 (worst)
Baseline and end of the 4-week pulmonary rehabilitation
Pichot Fatigue Scale
Délai: Baseline and end of the 4-week pulmonary rehabilitation
Ranging from 0 (better) to 32 (worst)
Baseline and end of the 4-week pulmonary rehabilitation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Frédéric Hérengt

Collaborateurs

HP2 laboratory INSERM U1042

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 août 2022

Achèvement primaire (Réel)

31 mai 2025

Achèvement de l'étude (Réel)

31 mai 2025

Dates d'inscription aux études

Première soumission

17 juin 2026

Première soumission répondant aux critères de contrôle qualité

25 juin 2026

Première publication (Réel)

1 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Dieulefit Sante

Plan pour les données individuelles des participants (IPD)

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OUI

Description du régime IPD

Data will be shared upon reasonable request to the contact person or contact back up person.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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