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NCT Number: NCT06578156

Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to consent
  • Age 18 years or older
  • Diagnosis of COPD
  • Ability to ambulate without assistance
  • Use of low-flow nasal cannula ≤ 4 L/min or no supplemental oxygen (O2) at all

Exclusion criteria

  • Pregnancy
  • Being on bedrest
  • Inability to consent or cooperate with the study
  • Using of > 4 L/min of supplemental O2 or requiring non-invasive ventilation during the daytime
  • Hemodynamic instability (resting heart rate > 130/minute, systolic blood pressure of ≤ 90 mmHg or ≥ 180 mmHg)
  • Metal implants in the thoracic regions (pacemakers, Automatic Implantable Cardioverter Defibrillator (AICD), plates, screws, rods, and disc replacements)

Treatment and study plan

Nasal High Flow Cannula

Device

High flow nasal cannula is a device that provides heated and humidified high flow gases. In-person. Depending on participant's availability, up to 6 times

Nasal Low Flow Cannula

Device

Low flow nasal cannula is a device that provides low flow gases. In-person. Depending on participant's availability, up to 6 times

Primary outcomes

  1. 6-minute walk test

    Time frame: 30 minutes

    The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The distance walked in meters over 6 minutes will be measured.

Secondary outcomes

  1. Breathing measured by the Borg dyspnea scale

    Time frame: 30 minutes

    This is a patient self-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, where "0" indicated no difficulty breathing, and "10" indicates a maximal breathing difficulty.

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • American Thoracic Society

Registry information

Official study title

Physiologic Effects of Nasal High Flow on Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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