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CompletedNCT07497230A-HFNC-PRUpdated Apr 1, 2026

Asymmetric High-Flow Nasal Cannula During Pulmonary Rehabilitation in COPD

An interventional study of Asymmetric High-Flow Nasal Cannula (A-HFNC) and Conventional Pulmonary Rehabilitation Program in Pulmonary Disease, Chronic Obstructive (COPD), Dyspnea and Exercise Tolerance, sponsored by Universidad de Santiago de Chile. Completed at 1 site in Chile. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Universidad de Santiago de Chile · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Pulmonary Rehabilitation
  • High-Flow Nasal Cannula
  • Asymmetric High-Flow Nasal Cannula
  • COPD
  • Exercise Training
  • Exercise Tolerance
  • Feasibility Study
  • Pilot Trial
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Universidad de Santiago de Chile is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Experimental Group

    Conventional pulmonary rehabilitation program (12 supervised sessions) supplemented with asymmetric high-flow nasal cannula (A-HFNC) during aerobic training. Flow rate, temperature, and FiO₂ were individualized according to oxygen saturation and patient tolerance.

    Device: Asymmetric High-Flow Nasal Cannula (A-HFNC)

  • Active comparator
    Control Group

    Conventional pulmonary rehabilitation program (12 supervised sessions) including treadmill aerobic exercise, upper and lower limb resistance training, and patient education, without any supplemental device during training.

    Other: Conventional Pulmonary Rehabilitation Program

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.

06

What researchers measure

Primary outcomes

  1. Incremental Load Test Duration

    Total exercise duration in seconds achieved during an incremental load test using the modified Bruce protocol on a treadmill. Reflects maximal cardiorespiratory exercise capacity.

    Time frame: Baseline and post-intervention (week 6)

07

Study locations

1 site
  • Hospital Clínico San José
    Santiago, Chile
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared publicly due to the small sample size, which could compromise participant confidentiality despite anonymization procedures.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07497230
Lead sponsor
Universidad de Santiago de Chile
Responsible party
Manuel Gálvez Reyes (Principal Investigator, School of Kinesiology, Universidad de Santiago de Chile, Universidad de Santiago de Chile) — Principal investigator
First posted
Mar 27, 2026
Start date
May 2, 2025
Primary completion
Sep 20, 2025
Completion
Sep 20, 2025
Last update
Apr 1, 2026

Study contacts

Manuel A GAlvez, MSc
principal investigator · Universidad de Santiago de Chile

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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