Intersticial Lung Disease
Conditions
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.
Interventions
DRUGoxygen therapy
conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effort capacity (Benefits in terms of meters walked in the 6mwt). | 8 weeks | 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. |
| Basal dyspnoea (mesured by mMRC scale). | 8 weeks | To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale. |
| Dyspnoea (benefits in borg scale) DURING effort. | 8 weeks | To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale. |
| Quality of life (SF36 questionnaire). | 8 weeks | To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire). |
| Quality of life (KBILD questionnaire). | 8 weeks | To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire). |
| Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire). | 8 weeks | To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire. |
Outcome results
None listed