Effect of High Flow Nasal During Exercise in COPD Patients

Study Overview
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Brief Summary
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Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. High flow ventilation in reducing work of breathing and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients

Official Title
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Acute Effects of High Flow Nasal Support During Exercise in Patients With COPD After Severe Exacerbation

Conditions
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COPD Exacerbation

Intervention / Treatment
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* Device: High Flow nasal cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of COPD Exclusion Criteria: exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise. pH < 7,35 Body temperature > 38°C cardiac frequency > 100 bpm at rest systolic blood pressure < 100 mmHg exacerbation during the study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 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 Test<br>Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with High Flow Nasal at 60L/min (with or without additional oxygen) | Device: High Flow nasal cannula<br>* High intensity Constant Work-Rate exercise test with High Flow Nasal Cannula in COPD patients involved in a Pulmonary Rehabilitation Program after an exacerbation (< 7 days after hospital discharge). High Flow nasal will be administered through nasal cannula using the Airvo2 (Fisher&Paykel)<br>|
| No Intervention: Control Test<br>Patient will perform one Constant Work-Rate Exercise Test at 80% of maximum workload on room air or with oxygen supplementation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in exercise capacity | Difference in endurance time (TLim) during High Intensity Constant Work-Rate Endurence Test (CWRET) | The outcome will be measure after every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in peripheral muscle oxygenation | Muscle oxygenation will be evaluated using Near-infrared spectroscopy technology. | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise | 
| Difference in Dyspnea and muscular fatigue | Difference in dyspnea and muscular fatigue using Modified Borg Scale (0 - 10 points) | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be collected every 2 minute during tests and at the end of the exercise | 
| Difference in Oxygen Saturation | Difference in Oxygen Saturation using a pulse oximetry (SpO2) | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise | 
| Difference in Cardiac Frequency | Difference in Cardiac Frequence using a pulse oximetry | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise | 
| Difference in Transcutaneous Carbon Dioxide | Difference Transcutaneous Carbon Dioxide using Transcutaneous Carbon Dioxide using a Transcutaneous capnography | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise | 
| Difference in Respiratory Rate | Difference in Respiratory Rate using a Respiratory Inductive Plethysmography | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise | 
| Difference in Respiratory Muscle Fatigue | Difference in Respiratory Muscle Fatigue using an electronical manometer | The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be collected before and 5 minute maximum after exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Exercise, High Flow Nasal, Muscle Oxygenation, Pulmonary Rehabilitation