High Flow Nasal Cannula and Exercise Testing in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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In this study the investigators will determine whether the use of High Flow Nasal Cannula Oxygen during test enhances exercise performance in COPD patients on a treadmill.

Detailed Description
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Design: interventional, crossover, randomized. The main goal of this study is to compare the maximum speed reached in an Incremental Load Treadmill Test (ILTT) and max time tolerated in a Constant Treadmill Load Test (CTLT) while using High Flow Nasal Cannula Oxygen (HFNCO). Patients will be evaluated through two different kinds of tests: Incremental Load Treadmill Test (ILTT) and Constant Treadmill Load Test (CTLT). Each test will be conducted two times, once using High Flow Nasal Cannula Oxygen and the other breathing room air. In total, each patient will be evaluated four times on four different visits. The testing order will be randomized through STATA. The following variables will be measured before, during and after each test: Max speed reached in an Incremental load test: Km/h Max time tolerate in a Constant Load Test: in seconds Oxygen saturation: % Dyspnea: Modified Borg scale (0-10) Cardiac rate: beats per minute Respiratory rate: breaths per minute Blood pressure: mmHg Lower limbs fatigue: modified Borg scale (0-10) Global comfort according to the device used: visual analogue scale (VAS) 0-10

Official Title
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Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula

Conditions
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COPD

Intervention / Treatment
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* Device: High Flow Nasal Cannula Oxygen
* Device: Treadmill


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

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Flow Nasal Cannula Oxygen<br>Incremental Load Treadmill Test (ILTT) using HFNCO at 21% Constant Treadmill Load Test (CTLT) using HFNCO at 21% | Device: High Flow Nasal Cannula Oxygen<br>* Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.<br>* Other names: HFNCO;|
| Other: Control Group<br>Incremental Load Treadmill Test (ILTT) at Room Air Constant Treadmill Load Test (CTLT) at Room Air | Device: Treadmill<br>* Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Exercise capacity - Maximun Walking Time Tolerated | Difference in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds between HFNCO and Room air | Baseline and 48 hs after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Dyspnea | Difference in dyspnea using Modified Borg Scale (0 - 10 points) between HFNCO and Room air | Baseline and 48 hs after baseline | 
| Difference in Cardiac Rate | Difference in Cardiac Rate (beats per minute) using a pulse oximetry between HFNCO and Room air | Baseline and 48 hs after baseline | 
| Difference in Oxygen Saturation | Difference in Oxygen Saturation using a pulse oximetry (SpO2) between HFNCO and Room air | Baseline and 48 hs after baseline | 
| Difference in Global Comfort | Difference in global comfort according to the device used with visual analogue scale (VAS) 0-10 between HFNCO and Room air | Baseline and 48 hs after baseline | 
| Difference in Lower Limbs Fatigue | Difference in Lower limbs fatigue using modified Borg scale (0-10) between HFNCO and Room air | Baseline and 48 hs after baseline | 
| Difference in Respiratory Rate | Difference in Respiratory rate in breaths per minute between HFNCO and Room air | Baseline and 48 hs after baseline | 
| Difference in Blood Pressure | Difference in of Blood pressure in mmHg between HFNCO and Room air | Baseline and 48 hs after baseline | 
| Difference in Exercise capacity - Maximun Walking Speed Reached | Difference in Maximun walking speed in km/h reached in an Incremental load treadmill test (ILTT) between HFNCO and Room air | Baseline and 48 hs after baseline | 

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