High Flow Nasal Cannula and Exercise Testing in Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- COPD
- Interventions
- Device: High Flow Nasal Cannula OxygenDevice: Treadmill
- Registration Number
- NCT02860273
- Lead Sponsor
- Hospital Italiano de Buenos Aires
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Clinically stable defined as four weeks without exacerbation.
- Signed Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High Flow Nasal Cannula Oxygen High Flow Nasal Cannula Oxygen 1. Incremental Load Treadmill Test (ILTT) using HFNCO at 21% 2. Constant Treadmill Load Test (CTLT) using HFNCO at 21% Control Group Treadmill 1. Incremental Load Treadmill Test (ILTT) at Room Air 2. Constant Treadmill Load Test (CTLT) at Room Air
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
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 Respiratory Rate Baseline and 48 hs after baseline Difference in Respiratory rate in breaths per minute between HFNCO and Room air
Trial Locations
- Locations (1)
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina