Nasal High-flow Oxygen Therapy During Rehabilitive Exercise Training in ILD (PID-OX)
25 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Auvergne-Rhône-Alpes
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Dieulefit, Auvergne-Rhône-Alpes, França, 26220
- Association Dieulefit Santé
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Nasal high-flow oxygen therapy
Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50)
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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.
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Comparador Ativo: Conventional oxygen therapy
Conventional oxygen therapy (nasal canula; flow= 4-9 L/min; inspired fraction of O2= 1.0)
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Constant Work Rate Endurance Time (CWRET)
Prazo: Baseline and end of the 4-week PR program.
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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.
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Baseline and end of the 4-week PR program.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Six-Minute Walk Distance
Prazo: Baseline and end of the 4-week pulmonary rehabilitation.
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Distance walked during the 6-Minute Walk Test.
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Baseline and end of the 4-week pulmonary rehabilitation.
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Dyspnea, Leg Discomfort and Rate of Percieved Exertion (RPE)
Prazo: 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.
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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.
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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.
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Pulmonary responses to exercise
Prazo: Baseline and end of the 4-week pulmonary rehabilitation.
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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.
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Baseline and end of the 4-week pulmonary rehabilitation.
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Oxygen saturation
Prazo: During each of the 20 exercise training sessions on a bicycle ergometer.
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By pulse oximetry
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During each of the 20 exercise training sessions on a bicycle ergometer.
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Heart Rate
Prazo: Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.
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Using electrocardiogram, in beats/min
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Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.
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Power
Prazo: During each of the 20 exercise training sessions on a bicycle ergometer. During the CPET, baseline and end of the 4-week pulmonary rehabilitation
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During each of the 20 exercise training sessions on a bicycle ergometer. During the CPET, baseline and end of the 4-week pulmonary rehabilitation
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Near Infrared Spetroscopy
Prazo: Baseline and end of the 4-week PR
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Of the Vastus Lateralis, used during the CPET and CWRET.
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Baseline and end of the 4-week PR
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King's Brief Interstitial Lung Disease (K-BILD)
Prazo: Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (worst) to 100 (better)
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Baseline and end of the 4-week pulmonary rehabilitation
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modified Medical Research Council (mMRC)
Prazo: Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 4 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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Hospital Anxiety and Depression Scale (HADS)
Prazo: Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 21 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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Pichot Fatigue Scale
Prazo: Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 32 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de agosto de 2022
Conclusão Primária (Real)
31 de maio de 2025
Conclusão do estudo (Real)
31 de maio de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
17 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de junho de 2026
Primeira postagem (Real)
1 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Dieulefit Sante
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Data will be shared upon reasonable request to the contact person or contact back up person.
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