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| Name | Class |
|---|---|
| HP2 laboratory INSERM U1042 | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal high-flow oxygen therapy | Experimental | Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50) |
|
| Conventional oxygen therapy | Active Comparator | Conventional oxygen therapy (nasal canula; flow= 4-9 L/min; inspired fraction of O2= 1.0) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-Minute Walk Distance | 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) |
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Inclusion Criteria:
Non-inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Association Dieulefit Santé | Dieulefit | Auvergne-Rhône-Alpes | 26220 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34559419 | Background | 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. | |
| 34225230 | 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. |
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Data will be shared upon reasonable request to the contact person or contact back up person.
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Single-center, randomized-controlled, single-blind (participants) study
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|
| 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. |
|
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 | 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 | By pulse oximetry | During each of the 20 exercise training sessions on a bicycle ergometer. |
| Heart Rate | 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 | 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. | Baseline and end of the 4-week PR |
| King's Brief Interstitial Lung Disease (K-BILD) | Ranging from 0 (worst) to 100 (better) | Baseline and end of the 4-week pulmonary rehabilitation |
| modified Medical Research Council (mMRC) | Ranging from 0 (better) to 4 (worst) | Baseline and end of the 4-week pulmonary rehabilitation |
| Hospital Anxiety and Depression Scale (HADS) | Ranging from 0 (better) to 21 (worst) | Baseline and end of the 4-week pulmonary rehabilitation |
| Pichot Fatigue Scale | Ranging from 0 (better) to 32 (worst) | Baseline and end of the 4-week pulmonary rehabilitation |
| 20516666 | 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. |
| 37581410 | 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. |