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)
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Hospital Italiano de Buenos AIres
Buenos Aires, Argentina
RECRUITINGChange 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)
Time frame: 8 weeks
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
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Time frame: 8 weeks
Dyspnea
The modified Medical research Council Scale (0-4) will be used in order to assess the breathless subjective sensation.
Time frame: 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
Time frame: 8 weeks