COPD
Conditions
Keywords
Pulmonary Rehabilitation, High Flow Nasal Cannula, The Venturi Mask, Exercise capacity, Aerobic capacity, HFNC
Brief summary
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
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).
Interventions
DEVICEHigh Flow Nasal Cannula
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.
DEVICEThe Venturi Mask
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.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Long term oxygen therapy (LTOT) or oxygen needs during exercise. 2. Clinically stable defined as four weeks without exacerbation
Exclusion criteria
1. Refusal to participate 2. Any neuromuscular, cardiovascular or any other condition that limits test performance. 3. Contraindication for exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Capacity - Maximum Walking Time Reached | 8 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity - Maximum Walking Speed Reached | 8 weeks | 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) |
| Quality of Life - The St George's Respiratory Questionnaire | 8 weeks | 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. |
| Six Minutes Walking Test | 8 weeks | 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. |
| Dyspnea | 8 weeks | The modified Medical research Council Scale (0-4) will be used in order to assess the breathless subjective sensation. |
| Comfort | 8 weeks | 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 |
| Quality of Life -Chronic Obstructive Pulmonary Disease Assessment Test | 8 weeks | 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. |
Countries
Argentina
Contacts
Primary ContactNicolas NR Roux, PT-RT
Backup ContactSilvina SD Dell'Era, PT-RT
Outcome results
None listed