High Flow Nasal Cannula and Aerobic Capacity Training

Study Overview
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Brief Summary
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The aim of this study is to compare exercise capacity in Chronic Obstructive Pulmonary Disease (COPD) patients before and after an 8 week pulmonary rehabilitation program. Patients will be randomised in two groups, one arm will received oxygen through High Flow Nasal Cannula (HFNC) and the other group by The Venturi Mask (VM)

Detailed Description
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Design: randomized, single blind, controlled trial. The main goal of this study is to compare the exercise tolerance in COPD patients after an 8 week pulmonary rehabilitation program using High Flow Nasal Cannula or The Venturi Mask. The exercise tolerance will be measured in seconds in a Constant Load Treadmill Test (CTLT).

Official Title
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High Flow Nasal Cannula Versus The Venturi Mask During Exercise Training in Chronic Obstructive Pulmonary Disease Patients, a Randomized, Simple Blind, Controlled Trial.

Conditions
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COPD

Intervention / Treatment
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* Device: High Flow Nasal Cannula
* Device: The Venturi Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Long term oxygen therapy (LTOT) or oxygen needs during exercise. Clinically stable defined as four weeks without exacerbation Exclusion Criteria: Refusal to participate Any neuromuscular, cardiovascular or any other condition that limits test performance. Contraindication for exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Flow Nasal Cannula<br>During a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through High Flow Nasal Cannula (HFNC) while they are training aerobic capacity on the treadmill. | Device: High Flow Nasal Cannula<br>* During the pulmonary rehabilitation program, patients will train the aerobic capacity on a treadmill. Patients in the intervention arm will receive oxygen trough High Flow Nasal Cannula (HFNC) at 50 lpm and 40% of oxygen. The aerobic capacity training plan will be conducted three times a week over 24 sessions.<br>* Other names: HFNC;|
| Active Comparator: The Venturi Mask<br>During a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through The Venturi Mask (VM) while they are training aerobic capacity on the treadmill. | Device: The Venturi Mask<br>* During the pulmonary rehabilitation program, patients will train the aerobic capacity on a treadmill. Patients in the control arm will receive oxygen trough The Venturi Mask (VM) at 40% of oxygen. The aerobic capacity training plan will be conducted three times a week over 24 sessions.<br>* Other names: VM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exercise Capacity - Maximum Walking Time Reached | The exercise capacity test measures the maximum time (in minutes) reached during a Constant Load Treadmill Test (CLTT). The treadmill speed will be constant and set up at 90% of the maximum speed reached in the previous Incremental Load Treadmill Test (ILTT). The patient will walk at the same velocity until he exhausts his capacity thus ending the test. This CLTT will be performed three times, always after an Incremental Load Treadmill Test (ILTT) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minutes Walking Test | A Six Minute Walking Test will be conducted according to American Thoracic Society (ATS) guide. Patients will be asked to walk as much as they can in that period of time. During the test oxygen saturation and cardiac frequency will be recorded. | 8 weeks | 
| Exercise capacity - Maximum Walking Speed Reached | The exercise capacity test measures the maximum speed (in Km/h) reached during an Incremental Load Treadmill Test (ILTT). The test begins at a speed of 3km/h and each minute after will increase by 0.5 km/h. The patient will walk until he exhausts his capacity, once reached, the test will finished. This ILTT will be performed three times, always before the Constant Load Treadmill Test (CLTT) | 8 weeks | 
| Quality of Life - The St George's Respiratory Questionnaire | The St George's Respiratory Questionnaire (SGRQ) is an instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. | 8 weeks | 
| Quality of Life -Chronic Obstructive Pulmonary Disease Assessment Test | The Chronic Obstructive Pulmonary Disease Assessment Test (CAT) is a patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. | 8 weeks | 
| Dyspnea | The modified Medical research Council Scale (0-4) will be used in order to assess the breathless subjective sensation. | 8 weeks | 
| Comfort | Difference in global comfort according to the device used with visual analogue scale (VAS) 0-10 between High Flow Nasal Cannula and The Venturi Mask | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFNC, Pulmonary Rehabilitation, High Flow Nasal Cannula, The Venturi Mask, Exercise capacity, Aerobic capacity