Nasal High-flow Oxygen Therapy During Rehabilitive Exercise Training in ILD (PID-OX)
25 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
60
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Auvergne-Rhône-Alpes
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Dieulefit, Auvergne-Rhône-Alpes, Francia, 26220
- Association Dieulefit Santé
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Constant Work Rate Endurance Time (CWRET)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Six-Minute Walk Distance
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 agosto 2022
Completamento primario (Effettivo)
31 maggio 2025
Completamento dello studio (Effettivo)
31 maggio 2025
Date di iscrizione allo studio
Primo inviato
17 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
25 giugno 2026
Primo Inserito (Effettivo)
1 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Dieulefit Sante
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Data will be shared upon reasonable request to the contact person or contact back up person.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .