Effects of HFOT on Exercise Performance in Patients With COPD. A Randomized, Controlled Trial.

Study Overview
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Brief Summary
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This will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen therapy (HFOT) vs. low-flow oxygen therapy (LFOT) on cycling endurance in patients with chronic obstructive pulmonary disease (COPD).

Detailed Description
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This will be a randomized, cross-over trial evaluating the efficacy of nasal HFOT vs. LFOT on cycling endurance in patients with COPD. Each patient will perform two constant load cycling exercise tests to exhaustion using HFOT and LFOT on two consecutive days, respectively, according to randomization. The load of the cycle ergometer will be set at 75% of the individually estimated maximum work rate (Wmax). During exercise tests, LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator. HFOT will be applied by a dedicated large bore nasal cannula at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device.

Official Title
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Effects of High Flow Oxygen Therapy on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease. A Randomized, Controlled Trial.

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Combination Product: High-flow oxygen therapy (HFOT)
* Combination Product: Low-flow oxygen therapy (LFOT)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Men and women, 35 to 75 years of age, with moderate to severe COPD, (FEV1/FVC <0.7, FEV1 40-80% predicted, resting SpO2 ≥92%, PaCO2 <6 kPa at 760 m) who live <800 m will be invited. Exclusion criteria: COPD exacerbation, very severe COPD with hypoxemia (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92%), current heavy smoking (>20 cigarettes per day), comorbidities such as uncontrolled cardiovascular disease, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFOT first then LFOT<br> | Combination Product: High-flow oxygen therapy (HFOT)<br>* HFOT will be applied by a dedicated large bore nasal cannula (Optiflow+, Fisher&Paykel, New Zealand) at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device (myAIRVO2, Fisher&Paykel, New Zealand).<br>Combination Product: Low-flow oxygen therapy (LFOT)<br>* LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).<br>|
| Experimental: LFOT first then HFOT<br> | Combination Product: High-flow oxygen therapy (HFOT)<br>* HFOT will be applied by a dedicated large bore nasal cannula (Optiflow+, Fisher&Paykel, New Zealand) at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device (myAIRVO2, Fisher&Paykel, New Zealand).<br>Combination Product: Low-flow oxygen therapy (LFOT)<br>* LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise endurance time in seconds | Difference in the exercise endurance time between HFOT vs. LFOT during a constant load exercise test at 75% of the maximal work capacity. | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea sensation | Difference in the exercise induced dyspnea sensation between HFOT vs LFOT assessed by the BORG CR10 scale ranging from 0 no dyspnea at all to 10 Maximum of dyspnea assessed at the end of exercise. | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | 
| Subjective leg fatigue sensation | Difference in the exercise induced subjective leg fatigue sensation between HFOT vs LFOT assessed by the BORG CR10 scale ranging from 0 no leg fatigue at all to 10 Maximum of leg fatigue assessed at the end of exercise. | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | 
| Arterial blood gases | Difference of parameters in the arterial blood gases, in particular pH, SaO2, PaO2 and PaCO2 between HFOT vs. LFOT at the end of exercise. | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | 
| Heart rate in bpm | Difference in the maximal heart rate assessed by ECG between HFOT vs. LFOT at the end of exercise. | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | 
| Arterial blood pressure in mmHg | Difference in the maximal blood pressure between HFOT vs. LFOT at the end of exercise. | HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise endurance, High-flow oxygen therapy, Low-flow oxygen therapy