Interstitial Lung Disease (ILD)PID-OXNCT07679854

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

A study testing Pulmonary rehabilitation with NHFO2 and Pulmonary rehabiltation with conventional oxygen therapy in people with Interstitial Lung Disease (ILD), run by Frédéric Hérengt at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Interstitial Lung Disease (ILD)
What is being tested?: Pulmonary rehabilitation with NHFO2 and Pulmonary rehabiltation with conventional oxygen therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteFrance
Study dates: 1 Aug 2022to 31 May 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

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

Other trials in France

About this study

Official title: 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.

Conditions: Interstitial Lung Disease (ILD)
Being tested: Pulmonary rehabilitation with NHFO2, Pulmonary rehabiltation with conventional oxygen therapy
Medical subject headings: Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulmonary rehabilitation with NHFO2Other
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.
Pulmonary rehabiltation with conventional oxygen therapyOther
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.

Study groups in NCT07679854
Study group	Role	What they receive
Nasal high-flow oxygen therapy	Experimental	Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50) Receives: 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) Receives: Other: Pulmonary rehabiltation with conventional oxygen therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and end of the 4-week PR program.

Secondary outcomes (11)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202231 May 2025

First posted1 Jul 2026
Study start1 Aug 2022
Primary completion31 May 2025
Study completion31 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-center, randomized-controlled, single-blind (participants) study
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07679854
Sponsor's protocol ID: Dieulefit Sante
Acronym: PID-OX
Status last verified: Jun 2026
First submitted: 17 Jun 2026
Last updated: 1 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be shared upon reasonable request to the contact person or contact back up person.

Publications

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.
PubMed 34559419
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.
PubMed 34225230
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.
PubMed 20516666
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.
PubMed 37581410

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)

All Interstitial Lung Disease (ILD) trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Nasal High-Flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?
ClinicalTrials.gov ID: NCT07679854
Acronym / sponsor ID: PID-OX / Dieulefit Sante
Conditions: Interstitial Lung Disease (ILD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Frédéric HérengtUniversity, hospital or other
Collaborators: HP2 laboratory INSERM U1042
Study start: 1 Aug 2022 (actual)
Primary completion: 31 May 2025 (actual)
Study completion: 31 May 2025 (actual)
First posted: 1 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Single-center, randomized-controlled, single-blind (participants) study

Arm	Type	Receives
Nasal high-flow oxygen therapy	Experimental	Other: Pulmonary rehabilitation with NHFO2Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50)
Conventional oxygen therapy	Active comparator	Other: Pulmonary rehabiltation with conventional oxygen therapyConventional oxygen therapy (nasal canula; flow= 4-9 L/min; inspired fraction of O2= 1.0)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulmonary rehabilitation with NHFO2Participants 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.	Other	Nasal high-flow oxygen therapy
Pulmonary rehabiltation with conventional oxygen therapyParticipants 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.	Other	Conventional oxygen therapy

Primary outcome

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.

11 secondary outcomes

Six-Minute Walk Distance
Time frame: 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.
Pulmonary responses to exercise
Time frame: 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.
Heart Rate
Time frame: 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
Near Infrared Spetroscopy
Time frame: 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
modified Medical Research Council (mMRC)
Time frame: 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
Pichot Fatigue Scale
Time frame: Baseline and end of the 4-week pulmonary rehabilitation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Background: PubMed 34559419Dowman 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.
Background: PubMed 34225230Al 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.
Background: PubMed 20516666Kozu 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.
Background: PubMed 37581410Rochester 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.
Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request to the contact person or contact back up person.

Related trials for Interstitial Lung Disease (ILD)

RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Constant Work Rate Endurance Time (CWRET) (time frame: Baseline and end of the 4-week PR program.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07679854, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.