Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

Not Applicable

Recruiting

• Conditions: COPD

• Registration Number: NCT06578156
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-29
• Status Verified: 2024-12
• Study Start: 2024-12-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-16
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
6-minute walk test	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 Outcome Measures

Name	Time	Method
Breathing measured by the Borg dyspnea scale	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States