Pulmonary Disease, Chronic Obstructive (COPD)A-HFNC-PRNCT07497230
Asymmetric High-Flow Nasal Cannula During Pulmonary Rehabilitation in COPD
A study testing Asymmetric High-Flow Nasal Cannula (A-HFNC) and Conventional Pulmonary Rehabilitation Program in people with Pulmonary Disease, Chronic Obstructive (COPD) and Dyspnea, run by Universidad de Santiago de Chile at 1 site in Chile.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive (COPD), Dyspnea, Exercise Tolerance
- What is being tested?
- Asymmetric High-Flow Nasal Cannula (A-HFNC) and Conventional Pulmonary Rehabilitation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 2 May 2025to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Effects of Asymmetric High-flow Nasal Cannula During Exercise-based Pulmonary Rehabilitation in Patients With COPD: a Randomized Pilot Trial
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive (COPD), Dyspnea, Exercise Tolerance, Rehabilitation
- Being tested
- Asymmetric High-Flow Nasal Cannula (A-HFNC), Conventional Pulmonary Rehabilitation Program
- Keywords
- Pulmonary Rehabilitation, High-Flow Nasal Cannula, Asymmetric High-Flow Nasal Cannula, COPD, Exercise Training, Exercise Tolerance, Feasibility Study, Pilot Trial
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional Pulmonary Rehabilitation ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Pulmonary Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start2 May 2025
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic Obstructive (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Santiago de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Gálvez Reyes, Universidad de Santiago de Chile
- Investigators
- Manuel A GAlvez, MSc, Principal investigator, Universidad de Santiago de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497230
- Sponsor's protocol ID
- 276/2025
- Acronym
- A-HFNC-PR
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to the small sample size, which could compromise participant confidentiality despite anonymization procedures.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effects of Asymmetric High-flow Nasal Cannula During Exercise-based Pulmonary Rehabilitation in Patients With COPD: a Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT07497230
- Acronym / sponsor ID
- A-HFNC-PR / 276/2025
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de Santiago de ChileUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Asymmetric High-Flow Nasal Cannula (A-HFNC)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. |
| Control Group | Active comparator | Other: Conventional Pulmonary Rehabilitation ProgramConventional 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asymmetric 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. | Device | Experimental Group |
| Conventional Pulmonary Rehabilitation ProgramTwelve 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. | Other | Control Group |
Primary outcome
Incremental Load Test Duration
Time frame: Baseline 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to the small sample size, which could compromise participant confidentiality despite anonymization procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel A GAlvez, MSc principal investigator
Universidad de Santiago de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asymmetric High-Flow Nasal Cannula (A-HFNC) and Conventional Pulmonary Rehabilitation Program in people with Pulmonary Disease, Chronic Obstructive (COPD) and Dyspnea, run by Universidad de Santiago de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Load Test Duration (time frame: Baseline and post-intervention (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.