COPD
Conditions
Keywords
Pulmonary Rehabilitation, COPD, High Flow Nasal Cannula, HFNC, Aerobic capacity
Brief summary
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
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
Interventions
Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.
DEVICETreadmill
Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Exercise capacity - Maximun Walking Time Tolerated | Baseline and 48 hs after baseline | Difference in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds between HFNCO and Room air |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Cardiac Rate | Baseline and 48 hs after baseline | Difference in Cardiac Rate (beats per minute) using a pulse oximetry between HFNCO and Room air |
| Difference in Oxygen Saturation | Baseline and 48 hs after baseline | Difference in Oxygen Saturation using a pulse oximetry (SpO2) between HFNCO and Room air |
| Difference in Global Comfort | Baseline and 48 hs after baseline | Difference in global comfort according to the device used with visual analogue scale (VAS) 0-10 between HFNCO and Room air |
| Difference in Dyspnea | Baseline and 48 hs after baseline | Difference in dyspnea using Modified Borg Scale (0 - 10 points) between HFNCO and Room air |
| Difference in Respiratory Rate | Baseline and 48 hs after baseline | Difference in Respiratory rate in breaths per minute between HFNCO and Room air |
| Difference in Blood Pressure | Baseline and 48 hs after baseline | Difference in of Blood pressure in mmHg between HFNCO and Room air |
| Difference in Exercise capacity - Maximun Walking Speed Reached | Baseline and 48 hs after baseline | Difference in Maximun walking speed in km/h reached in an Incremental load treadmill test (ILTT) between HFNCO and Room air |
| Difference in Lower Limbs Fatigue | Baseline and 48 hs after baseline | Difference in Lower limbs fatigue using modified Borg scale (0-10) between HFNCO and Room air |
Countries
Argentina
Outcome results
None listed