Nasal High-flow Oxygen Therapy During Rehabilitive Exercise Training in ILD (PID-OX)
25. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Auvergne-Rhône-Alpes
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Dieulefit, Auvergne-Rhône-Alpes, Frankreich, 26220
- Association Dieulefit Santé
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Constant Work Rate Endurance Time (CWRET)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Six-Minute Walk Distance
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. August 2022
Primärer Abschluss (Tatsächlich)
31. Mai 2025
Studienabschluss (Tatsächlich)
31. Mai 2025
Studienanmeldedaten
Zuerst eingereicht
17. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
25. Juni 2026
Zuerst gepostet (Tatsächlich)
1. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Dieulefit Sante
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Data will be shared upon reasonable request to the contact person or contact back up person.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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