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Nasal High-flow Oxygen Therapy During Acute Exercise in Fibrotic Interstitial Lung Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07129707
Acronym
PID-OXacute
Enrollment
15
Registered
2025-08-19
Start date
2023-12-01
Completion date
2025-01-31
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease (ILD)

Keywords

Dyspnea, Exercise, Oxygen inhalation therapy, Pulmonary fibrosis

Brief summary

Hallmarks of fibrotic interstitial lung disease (f-ILD) include severe hypoxemia, dyspnea and exercise limitation. Although ambulatory oxygen (O2) therapy is widely prescribed, standard low-flow O2 systems (nasal prongs) fail to meet patients' inspiratory demand on exertion resulting in incomplete correction of hypoxemia and limited symptomatic relief. Nasal high-flow O2 therapy (NHFO2) delivers heated, humidified, and O2-enriched air at high flow rates. It has recently emerged as a promising alternative to overcome the pre-specified limitations: NHFO2 is more effective in correcting hypoxemia and reducing dyspnea vs standard O2 therapy and consistently improved exercise capacity in f-ILD. In fact, NHF per se may exert independent physiological benefits such as washout of the anatomical dead space and reduced work of breathing. However, the respective effect of respiratory support and improved oxygenation on dyspnea and exercise tolerance remain unexplored in f-ILD. To address this gap in knowledge, this prospective, randomized-controlled trial aimed to disentangle the i) independent and ii) combined effects of respiratory support and supplemental O2 on dyspnea and exercise tolerance in patients with f-ILD.

Interventions

Each participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms).

Sponsors

Dieulefit Santé Centre de Réadaptation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

Crossover - 4 experimental conditions

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosis of fibrotic interstitial lung disease (regardless of etiology) * age ≥18 years * modified Medical Research Council scale ≥1 * stable condition (no acute exacerbation within the preceding 3 months)

Exclusion criteria

* inability to perform a cardiopulmonary exercise test (CPET) on a bicycle ergometer * participation in a pulmonary rehabilitation program within the last 6 months

Design outcomes

Primary

MeasureTime frameDescription
Time to exercise intolerance4 times over 2 consecutive days (1 time per experimental condition)Measured during a constant work-rate exercise test (70% peak work rate)
Isotime dyspnea4 times over 2 consecutive days (1 time per experimental condition)0-10 category-ratio Borg scale

Secondary

MeasureTime frameDescription
Breathing pattern4 times over 2 consecutive days (1 time per experimental condition)Respiratory inductive plethysmography
Gas exchange4 times over 2 consecutive days (1 time per experimental condition)Earlobe capnography
Quadriceps muscle oxygenation4 times over 2 consecutive days (1 time per experimental condition)Near-infrared spectroscopy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026