Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?

Study Overview
=================
Brief Summary
-----------------
Objectives: 1.- To compare the level of oxygenation achieved during muscular training with conventional oxygen systems (nasal cannulas) versus nasal High-flow oxygen therapy. 2.-To compare benefits achieved with both systems, in terms of: level of exercise during training; effort tolerance in the 6 minutes walking test (6MWT); improvement of dyspnoea and Health-related quality of life (HRQoL). And analyse the effects of nasal High-flow oxygen therapy on the acute exercise in a subgroup of patients. Method: Multicentric randomized clinical trial. Patients with ILD in fibrotic phase who present oxygen desaturation during 6MWT (SpO2 mean ≤ 85%) will be included consecutively. Will be randomized in two groups: ILD patients with conventional oxygen (EPIDOC) and ILD patients with nasal High-Flow oxygen therapy (EPIDOAF). Both groups will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated respectively to flow and FiO2 needed to maintain SpO2 ≥ 90% during training with both systems. Evaluation measures: SpO2 during training in both groups; dyspnoea (mMRC scale and CRQ dyspnoea); exercise capacity (6MWT) and HRQoL (self- administered KBILD questionnaire and SF36). In a subgroup of patients will be compared time of endurance exercise to evaluate the effects of nasal high-flow oxygen therapy in the acute exercise.

Official Title
-----------------
Can Nasal High-Flow Oxygen Therapy Improve Oxygenation During Exercise, Optimizing Benefits of Pulmonary Rehabilitation in Patients With Interstitial Lung Disease (ILD) With Exercise Desaturation?

Conditions
-----------------
Intersticial Lung Disease

Intervention / Treatment
-----------------
* Drug: oxygen therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 30 years old Diagnostic of ILD according to the national and international guidelines 23 Being clinically stable the previous 4 weeks Acceptance to participate in the trial Exclusion Criteria: Have been enrolled in a PR program in the last previous 6 months Respiratory Diseases other than ILD or severe comorbidities Osteoarticular diseases which don't allow training End-stage ILD, treatment with opiates or survival < 6 months Cognitive alterations that preclude colaboration

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional oxygen (EPIDOC)<br>Patients randomized in conventional oxygen (EPIDOC) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to flow needed to maintain SpO2 ≥ 90% during training with both systems. | Drug: oxygen therapy<br>* conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.<br>|
| Active Comparator: Nasal High-Flow oxygen therapy (EPIDOAF)<br>Patients will be randomized in nasal High-Flow oxygen therapy (EPIDOAF) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to FiO2 needed to maintain SpO2 ≥ 90% during training with both systems. | Drug: oxygen therapy<br>* conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation | To compare the level of oxygenation (in SatO2 %) achieved by conventional oxygen therapy and nasal high flow oxygen therapy during muscular training program in patients with ILD measured by pulseoxymetry. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnoea (benefits in borg scale) DURING effort. | To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale. | 8 weeks | 
| Effort capacity (Benefits in terms of meters walked in the 6mwt). | To compare the benefits achieved by both systems in terms of Effort tolerance after PR program, evaluated with the 6 minut waking test (6WT), in meters. | 8 weeks | 
| Basal dyspnoea (mesured by mMRC scale). | To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale. | 8 weeks | 
| Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire). | To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire. | 8 weeks | 
| Quality of life (SF36 questionnaire). | To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire). | 8 weeks | 
| Quality of life (KBILD questionnaire). | To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire). | 8 weeks |