Clinical trial NCT03287713: Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intersticial Lung Disease
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation
timeFrame: 8 weeks
Secondary outcomes:
measure: Dyspnoea (benefits in borg scale) DURING effort.
timeFrame: 8 weeks
measure: Effort capacity (Benefits in terms of meters walked in the 6mwt).
timeFrame: 8 weeks
measure: Basal dyspnoea (mesured by mMRC scale).
timeFrame: 8 weeks
measure: Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).
timeFrame: 8 weeks
measure: Quality of life (SF36 questionnaire).
timeFrame: 8 weeks
measure: Quality of life (KBILD questionnaire).
timeFrame: 8 weeks
Other outcomes:
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