Can high-flow oxygen optimize the benefits of Pulmonary Rehabilitation in patients with Diffuse Interstitial LungDisease (ILD) with oxygen desaturation during effort?

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000895-27-ES

Enrollment

Unknown

Registered

2017-03-31

Start date

2017-07-21

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Diffuse Interstitial LungDisease (ILD)

Interventions

Trade Name: Conoxia Product Name: Oxigen Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: OXYGEN CAS Number: 7782-44-7 Concentration unit: % (V/V) percent volume/volume Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age> 30 years - Diagnosis of EPID according to national and international regulations - Sign the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Have performed a RR program (including training) in the last 6 months - Respiratory diseases other than DID (cardiac, neuromuscular, anemia and vascular) or important comorbidities - Osteoarticular diseases that make it difficult to perform exercise - End-stage disease (inability to perform exercises or treatment with morphs) - Life expectancy <6 months - Cognitive disorders that difficult active participation

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the level of oxygenation achieved during muscle training with conventional oxygen (nasal goggles) and high flow systems.;Secondary Objective: To compare the benefits achieved with the two oxygen therapy systems in terms of: - Level of effort achieved during training - Post-effort tolerance with 6mwt - Improvement in dyspnea - Improvement in Health-Related Quality of Life;Primary end point(s): The average oxyhemoglobin saturation (SpO2) achieved throughout the training period comparing that of both groups.;Timepoint(s) of evaluation of this end point: 8 weeks	—

Measure

Time frame

Main Objective: To compare the level of oxygenation achieved during muscle training with conventional oxygen (nasal goggles) and high flow systems.;Secondary Objective: To compare the benefits achieved with the two oxygen therapy systems in terms of: - Level of effort achieved during training - Post-effort tolerance with 6mwt - Improvement in dyspnea - Improvement in Health-Related Quality of Life;Primary end point(s): The average oxyhemoglobin saturation (SpO2) achieved throughout the training period comparing that of both groups.;Timepoint(s) of evaluation of this end point: 8 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - Dyspnea on exertion before and after P6MM (Borg scale) - Capacity of effort measured by the P6MM - HRQL using questionnaires Questionnaire KBILD and SF36 - Adverse effects of the program - Compliance with the program;Timepoint(s) of evaluation of this end point: 8 weeks	—

Countries

Spain

Contacts

Public ContactUICEC Sant Pau

Institut de Recerca Hospital de la Santa Creu i Sant Pau

epenag@santpau.cat+34935537636

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026