Interstitial Lung Disease (ILD)
Conditions
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.
Interventions
OTHERPulmonary 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.
OTHERPulmonary 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.
Sponsors
Frédéric Hérengt
HP2 laboratory INSERM U1042
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Single-center, randomized-controlled, single-blind (participants) study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant Work Rate Endurance Time (CWRET) | 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
| Measure | Time frame | Description |
|---|---|---|
| Six-Minute Walk Distance | Baseline and end of the 4-week pulmonary rehabilitation. | Distance walked during the 6-Minute Walk Test. |
| 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. | 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. |
| Pulmonary responses to exercise | 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. |
| Oxygen saturation | During each of the 20 exercise training sessions on a bicycle ergometer. | By pulse oximetry |
| Heart Rate | Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer. | Using electrocardiogram, in beats/min |
| Power | 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 | Baseline and end of the 4-week PR | Of the Vastus Lateralis, used during the CPET and CWRET. |
| King's Brief Interstitial Lung Disease (K-BILD) | Baseline and end of the 4-week pulmonary rehabilitation | Ranging from 0 (worst) to 100 (better) |
| modified Medical Research Council (mMRC) | Baseline and end of the 4-week pulmonary rehabilitation | Ranging from 0 (better) to 4 (worst) |
| Hospital Anxiety and Depression Scale (HADS) | Baseline and end of the 4-week pulmonary rehabilitation | Ranging from 0 (better) to 21 (worst) |
| Pichot Fatigue Scale | Baseline and end of the 4-week pulmonary rehabilitation | Ranging from 0 (better) to 32 (worst) |
Countries
France
Outcome results
None listed