Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD patients without conventional for LTOT but with exercise desaturation.

Detailed Description
-----------------
Oxygen will be administered through nasal cannulae. Patients will be provided with a tank of liquid oxygen and a rechargeable portable device. The 6 minuts walking test will be used to adjusted oxygen flow in the GFA group (to achieve a mean SpO2 ≥ 90%). In the control group (GC), a 3L/min oxygen flow will be administer. Oxygen is used when the patient perform physical activity. The treatment period for each patient is 6 months (3 months in the GC grup, 3 months in the GFA one).

Official Title
-----------------
Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation on Exercise But Without Conventional Criteria for Domiciliary Oxygen Therapy.

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical stable moderate to severe COPD (FEV1 <70%, FEV 1 / FVC <70%) total lung capacity (TLC> 80%) without conventional criteria for LTOT, optimal medical therapy, mean SpO2 ≤ 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation. Exclusion Criteria: Current smokers - Presence of respiratory failure and criteria for LTOT (PO2 <55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia). - Presence of impaired mobility - Cognitive impairment or intellectual disability to fill in questionnaires - No acceptance of liquid oxygen - Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) - Participation in pulmonary rehabilitation programs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxygen adjusted<br>oxygen adjusted to get SpO2> 90% during the walking test | Drug: oxygen<br>* Oxygen administered after adjustment during a waking test or at 3L/min<br>|
| Placebo Comparator: control group<br>oxygen at 3L/min | Drug: oxygen<br>* Oxygen administered after adjustment during a waking test or at 3L/min<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefits on HRQOL | The aim is to analyze the benefits on HRQOL of suitable correction of desaturation in COPD patients without conventional criteria for OCD but with exercise desaturation. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce breathlessness during exercise | Reduce breathlessness during exercise | 3 months | 
| Increase exercise capacity | Increase exercise capacity | 3 months | 
| Increasing physical activity | Increasing physical activity | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxygen therapy, COPD, exercise