High Flow Nasal Cannula and Aerobic Capacity Training

Not Applicable

• Conditions: COPD
• Interventions: Device: High Flow Nasal Cannula; Device: The Venturi Mask

• Registration Number: NCT02973945
• Lead Sponsor: Hospital Italiano de Buenos Aires

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).

Study Timeline

• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Status Verified: 2017-05
• Study Start: 2017-07-01
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20
• Primary Completion: 2019-03
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Flow Nasal Cannula	High Flow Nasal Cannula	During a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through High Flow Nasal Cannula (HFNC) while they are training aerobic capacity on the treadmill.
The Venturi Mask	The Venturi Mask	During a 8 week Pulmonary Rehabilitation Program patients will receive oxygen through The Venturi Mask (VM) while they are training aerobic capacity on the treadmill.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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

Trial Locations

Locations (1)

Hospital Italiano de Buenos AIres; 🇦🇷 Buenos Aires, Argentina