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

Not Applicable

• Conditions: Intersticial Lung Disease
• Interventions: Drug: oxygen therapy

• Registration Number: NCT03287713
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-09
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Study First Posted: 2017-09-19
• Last Update Posted: 2017-09-19
• Study Start: 2018-01
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional oxygen (EPIDOC)	oxygen therapy	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.
Nasal High-Flow oxygen therapy (EPIDOAF)	oxygen therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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).