Clinical trial NCT02860273: High Flow Nasal Cannula and Exercise Testing in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Pulmonary Rehabilitation
COPD
High Flow Nasal Cannula
HFNC
Aerobic capacity
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Exercise capacity - Maximun Walking Time Tolerated
timeFrame: Baseline and 48 hs after baseline
Secondary outcomes:
measure: Difference in Dyspnea
timeFrame: Baseline and 48 hs after baseline
measure: Difference in Cardiac Rate
timeFrame: Baseline and 48 hs after baseline
measure: Difference in Oxygen Saturation
timeFrame: Baseline and 48 hs after baseline
measure: Difference in Global Comfort
timeFrame: Baseline and 48 hs after baseline
measure: Difference in Lower Limbs Fatigue
timeFrame: Baseline and 48 hs after baseline
measure: Difference in Respiratory Rate
timeFrame: Baseline and 48 hs after baseline
measure: Difference in Blood Pressure
timeFrame: Baseline and 48 hs after baseline
measure: Difference in Exercise capacity - Maximun Walking Speed Reached
timeFrame: Baseline and 48 hs after baseline
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Nicolás NR Roux, PT-RT
role: PRINCIPAL_INVESTIGATOR
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