Nasal High-flow Oxygen Therapy During Rehabilitive Exercise Training in ILD

NCT07679854 | Completed

• 1 other identifier: Dieulefit Sante
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Interstitial Lung Disease (ILD)

Outcome Measures

Primary Outcomes (1)

• Constant Work Rate Endurance Time (CWRET)

  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.

Secondary Outcomes (11)

• 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.

Study Arms (2)

Nasal high-flow oxygen therapy

EXPERIMENTAL

Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50)

Other: Pulmonary rehabilitation with NHFO2

Conventional oxygen therapy

ACTIVE COMPARATOR

Conventional oxygen therapy (nasal canula; flow= 4-9 L/min; inspired fraction of O2= 1.0)

Other: Pulmonary rehabiltation with conventional oxygen therapy

Interventions

Pulmonary rehabilitation with NHFO2 OTHER

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.

Nasal high-flow oxygen therapy

Pulmonary rehabiltation with conventional oxygen therapy OTHER

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.

Conventional oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Pregnant or breastfeeding women.
• Individuals deprived of liberty by judicial or administrative decision.
• Adults under legal protection or guardianship.

Sponsors & Collaborators

• Frédéric Hérengt: lead
• HP2 laboratory INSERM U1042: collaborator

Study Sites (1)

Association Dieulefit Santé

Dieulefit, Auvergne-Rhône-Alpes, 26220, France

Location

Related Publications (4)

• 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.

  PMID: 34559419 BACKGROUND

• 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.

  PMID: 34225230 BACKGROUND

• 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.

  PMID: 20516666 BACKGROUND

• 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.

  PMID: 37581410 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Single-center, randomized-controlled, single-blind (participants) study

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 1, 2026
• Study Start: August 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)