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

June 25, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nasal high-flow oxygen therapy
Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50)
Other: 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.
Active Comparator: Conventional oxygen therapy
Conventional oxygen therapy (nasal canula; flow= 4-9 L/min; inspired fraction of O2= 1.0)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Constant Work Rate Endurance Time (CWRET)
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Six-Minute Walk Distance
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Frédéric Hérengt

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HP2 laboratory INSERM U1042

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dieulefit Sante

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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