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Asymmetric High-Flow Nasal Cannula During Pulmonary Rehabilitation in COPD

Feasibility and Preliminary Effects of Asymmetric High-flow Nasal Cannula During Exercise-based Pulmonary Rehabilitation in Patients With COPD: a Randomized Pilot Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07497230
Acronym
A-HFNC-PR
Enrollment
30
Registered
2026-03-27
Start date
2025-05-02
Completion date
2025-09-20
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea, Exercise Tolerance, Pulmonary Disease, Chronic Obstructive (COPD), Rehabilitation

Keywords

Pulmonary Rehabilitation, High-Flow Nasal Cannula, Asymmetric High-Flow Nasal Cannula, COPD, Exercise Training, Exercise Tolerance, Feasibility Study, Pilot Trial

Brief summary

This randomized pilot trial evaluated the feasibility and preliminary effects of using asymmetric high-flow nasal cannula (A-HFNC) during exercise-based pulmonary rehabilitation (PR) in patients with chronic obstructive pulmonary disease (COPD). Thirty patients were randomly assigned to conventional PR or PR supplemented with A-HFNC during aerobic training, completing 12 supervised sessions. The study assessed whether A-HFNC could be safely and acceptably incorporated into PR, and whether it enabled higher training intensity and improved exercise performance. Results showed that the intervention was feasible and safe, with 83% adherence in both groups and no adverse events. Patients in the A-HFNC group trained at significantly higher treadmill inclination and showed a clinically meaningful trend toward greater improvement in maximal exercise tolerance. These findings support the design of a larger definitive trial.

Detailed description

Chronic obstructive pulmonary disease (COPD) is a major cause of disability worldwide. Pulmonary rehabilitation (PR) is the most effective non-pharmacological intervention for COPD, but adherence is limited by exercise intolerance and dyspnea. Strategies that reduce ventilatory demand during exercise may help patients tolerate higher training intensities, potentially improving outcomes. Asymmetric high-flow nasal cannula (A-HFNC) delivers heated and humidified gas at high flow rates through an asymmetric nasal interface, promoting dead-space washout and reducing the work of breathing. These mechanisms may facilitate higher exercise intensity during PR. This pilot trial randomized 30 patients with COPD to two groups. The control group received a conventional 12-session supervised PR program including treadmill aerobic exercise, resistance training, and patient education. The experimental group followed the same program with A-HFNC applied during all aerobic training sessions. Flow rate, temperature, and fraction of inspired oxygen were individualized according to oxygen saturation and patient tolerance. Primary feasibility outcomes were recruitment rate, protocol adherence, and absence of serious adverse events. Exploratory clinical outcomes included six-minute walk distance, incremental load test performance (modified Bruce protocol), and COPD Assessment Test score, assessed at baseline and after the 12-session program. Secondary outcomes included heart rate, blood pressure, oxygen saturation, rate-pressure product, and perceived dyspnea. The study was conducted at the cardiopulmonary rehabilitation center of Hospital Clínico San José, Santiago, Chile, between May and September 2025. Ethics approval was obtained from the institutional review board (No. 276/2025). The trial was registered retrospectively upon manuscript preparation.

Interventions

DEVICEAsymmetric High-Flow Nasal Cannula (A-HFNC)

Experimental: Asymmetric high-flow nasal cannula (A-HFNC) applied during aerobic training sessions of a 12-session supervised pulmonary rehabilitation program. Flow rate was set at 50 L/min, temperature at 31-34°C, and FiO₂ at 21-36%, individualized according to oxygen saturation and patient tolerance. Aerobic exercise was performed on a treadmill with progressive intensity adjustment based on cardiorespiratory response. Control: Conventional 12-session supervised pulmonary rehabilitation program including treadmill aerobic exercise, upper and lower limb resistance training, and patient education. Aerobic workload was determined from baseline incremental load test and progressively adjusted based on cardiorespiratory response. No supplemental device was used during training.

OTHERConventional Pulmonary Rehabilitation Program

Twelve supervised pulmonary rehabilitation sessions including treadmill-based aerobic exercise, upper and lower limb resistance training, and patient education. Aerobic workload was determined from baseline incremental load test results and progressively adjusted according to each participant's cardiorespiratory response. Heart rate, oxygen saturation, and perceived dyspnea were continuously monitored during all sessions. No supplemental device was used during training.

Sponsors

Universidad de Santiago de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Participants were randomly allocated in a 1:1 ratio to one of two parallel arms: a control group receiving conventional pulmonary rehabilitation, or an experimental group receiving the same program supplemented with asymmetric high-flow nasal cannula (A-HFNC) during aerobic training sessions. Both groups completed 12 supervised sessions. No crossover between arms was performed.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 40 years or older * Spirometry-confirmed COPD diagnosis (post-bronchodilator FEV1/FVC ratio less than 0.70) * Modified Medical Research Council (mMRC) dyspnea grade 2 or higher * Spirometry performed within the preceding 12 months

Exclusion criteria

* Acute respiratory exacerbation within the preceding three months * Uncontrolled respiratory symptoms or any acute condition compromising clinical stability * Current use of home non-invasive mechanical ventilation or artificial airway * Hospitalization within the preceding three months * Neuromuscular or osteoarticular conditions limiting physical activity * Cognitive or communication difficulties precluding adherence to instructions * Recent acute cardiovascular events * Decompensated comorbidities

Design outcomes

Primary

MeasureTime frameDescription
Incremental Load Test DurationBaseline and post-intervention (week 6)Total exercise duration in seconds achieved during an incremental load test using the modified Bruce protocol on a treadmill. Reflects maximal cardiorespiratory exercise capacity.

Countries

Chile

Contacts

PRINCIPAL_INVESTIGATORManuel A GAlvez, MSc

Universidad de Santiago de Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026