Asymmetric High-Flow Nasal Cannula During Pulmonary Rehabilitation in COPD

NCT07497230 | Completed

• 1 other identifier: 276/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  Baseline and post-intervention (week 6)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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)

Control Group

ACTIVE COMPARATOR

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

Asymmetric High-Flow Nasal Cannula (A-HFNC) DEVICE

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.

Experimental Group

Conventional Pulmonary Rehabilitation Program OTHER

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.

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Santiago de Chile: lead

Study Sites (1)

Hospital Clínico San José

Santiago, Chile

Location

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Manuel A GAlvez, MSc

  Universidad de Santiago de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, School of Kinesiology, Universidad de Santiago de Chile

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: May 2, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)