Intersticial Lung Disease Clinical Trial
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?
| Verified date | September 2017 |
| Source | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | January 2021 |
| Est. primary completion date | January 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 100 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Quality of life (SF36 questionnaire). | To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire). | 8 weeks | |
| Secondary | Quality of life (KBILD questionnaire). | To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire). | 8 weeks |