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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional oxygen (EPIDOC) | Active Comparator | 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. |
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| Nasal High-Flow oxygen therapy (EPIDOAF) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxygen therapy | Drug | conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease. |
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| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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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 |