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Completed

NCT Number: NCT07679854

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

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.

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Key information

Conditions

Interstitial Lung Disease (ILD) Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Association Dieulefit Santé

Dieulefit, Auvergne-Rhône-Alpes, 26220, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Six-Minute Walk Distance

    Time frame: Baseline and end of the 4-week pulmonary rehabilitation.

    Distance walked during the 6-Minute Walk Test.

  2. 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.

  3. 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.

  4. Oxygen saturation

    Time frame: During each of the 20 exercise training sessions on a bicycle ergometer.

    By pulse oximetry

  5. 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

  6. 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

  7. Near Infrared Spetroscopy

    Time frame: Baseline and end of the 4-week PR

    Of the Vastus Lateralis, used during the CPET and CWRET.

  8. 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)

  9. modified Medical Research Council (mMRC)

    Time frame: Baseline and end of the 4-week pulmonary rehabilitation

    Ranging from 0 (better) to 4 (worst)

  10. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline and end of the 4-week pulmonary rehabilitation

    Ranging from 0 (better) to 21 (worst)

  11. Pichot Fatigue Scale

    Time frame: Baseline and end of the 4-week pulmonary rehabilitation

    Ranging from 0 (better) to 32 (worst)

Sponsors and collaborators

Lead sponsor

Frédéric Hérengt

Other

Collaborators

  • HP2 laboratory INSERM U1042

Registry information

Official study title

Does Nasal High-Flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?

Acronym: PID-OX

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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