High Flow Nasal Cannula and Exercise Testing in Chronic Obstructive Pulmonary Disease (COPD)

May 19, 2023 updated by: Hospital Italiano de Buenos Aires

Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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%
Device: High Flow Nasal Cannula Oxygen
Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.
Other Names:
  • HFNCO
Other: Control Group
  1. Incremental Load Treadmill Test (ILTT) at Room Air
  2. Constant Treadmill Load Test (CTLT) at Room Air
Device: Treadmill
Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Exercise capacity - Maximun Walking Time Tolerated
Time Frame: 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
Baseline and 48 hs after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Dyspnea
Time Frame: Baseline and 48 hs after baseline
Difference in dyspnea using Modified Borg Scale (0 - 10 points) between HFNCO and Room air
Baseline and 48 hs after baseline
Difference in Cardiac Rate
Time Frame: Baseline and 48 hs after baseline
Difference in Cardiac Rate (beats per minute) using a pulse oximetry between HFNCO and Room air
Baseline and 48 hs after baseline
Difference in Oxygen Saturation
Time Frame: Baseline and 48 hs after baseline
Difference in Oxygen Saturation using a pulse oximetry (SpO2) between HFNCO and Room air
Baseline and 48 hs after baseline
Difference in Global Comfort
Time Frame: 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
Baseline and 48 hs after baseline
Difference in Lower Limbs Fatigue
Time Frame: Baseline and 48 hs after baseline
Difference in Lower limbs fatigue using modified Borg scale (0-10) between HFNCO and Room air
Baseline and 48 hs after baseline
Difference in Respiratory Rate
Time Frame: Baseline and 48 hs after baseline
Difference in Respiratory rate in breaths per minute between HFNCO and Room air
Baseline and 48 hs after baseline
Difference in Blood Pressure
Time Frame: Baseline and 48 hs after baseline
Difference in of Blood pressure in mmHg between HFNCO and Room air
Baseline and 48 hs after baseline
Difference in Exercise capacity - Maximun Walking Speed Reached
Time Frame: 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
Baseline and 48 hs after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: Nicolás NR Roux, PT-RT, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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