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High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation.

21. maj 2026 opdateret af: Manuel Gálvez Reyes, Universidad de Santiago de Chile

Effect of High-Flow Nasal Cannula Use on Exercise Tolerance and Physical Performance in Heart Failure Patients Enrolled in a Cardiac Rehabilitation Program: A Randomized Crossover Trial.

The goal of this clinical trial is to learn if a high-flow nasal cannula (HFNC) - a device that delivers warm, humidified air through a small tube placed in the nostrils - can improve exercise tolerance in adults with heart failure who are entering a cardiac rehabilitation program. The main questions it aims to answer are:

  • Can HFNC help people with heart failure exercise for a longer time during a treadmill test?
  • Does HFNC lower how hard people feel they are working during exercise?

Researchers will compare exercise performance with HFNC to exercise performance without HFNC to see if HFNC helps people with heart failure tolerate exercise better.

Participants will:

  • Complete two treadmill exercise tests, one with HFNC and one without, in a randomly assigned order
  • Wait 48 to 72 hours between the two tests to allow full recovery
  • Have their heart rate, blood pressure, oxygen level, and breathing rate measured before and after each test

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

Heart failure (HF) is a chronic syndrome characterized by reduced cardiac output, exercise intolerance, and dyspnea. Despite the well-established benefits of cardiac rehabilitation, many HF patients have severely limited exercise capacity, which restricts the intensity and duration of training they can safely perform.

High-flow nasal cannula (HFNC) delivers heated, humidified air at flow rates of 50-60 L/min. Its physiological effects include reduction of inspiratory work, washout of nasopharyngeal dead space, generation of positive end-expiratory pressure, and improved mucociliary transport. These mechanisms may facilitate exercise in patients with cardiorespiratory limitations.

STUDY DESIGN

Randomized crossover trial. Each participant acts as their own control, completing two incremental treadmill tests in random order, separated by a washout period of 48-72 hours:

Condition A (experimental): HFNC via AIRVO 2™ device (Fisher & Paykel Healthcare) with asymmetric nasal cannula at 50-60 L/min, FiO₂ 0.21, temperature 34-37°C Condition B (control): no ventilatory support device

Randomization will be performed using randomizer.org. Before the experimental condition, participants will undergo an acclimatization period in which flow is increased by 10 L/min every 5-10 minutes until reaching the target flow or maximum tolerated flow.

EXERCISE PROTOCOL An incremental protocol will be used on the treadmill, which will consist of incline and a progressive increase in speed and grade. The test ends at voluntary exhaustion or when predefined safety stopping criteria are met.

SAFETY The test will be stopped if any of the following occur: chest pain, severe dyspnea (Borg ≥8), nausea or presyncope, cyanosis, SpO₂ below 90%, or heart rate above 85% of age-predicted maximum. The testing site will be equipped with automated external defibrillator, bag-valve mask, emergency oxygen, and at least one team member certified in advanced life support. Direct transfer to the hospital emergency service is available on-site (Complejo Hospitalario San José).

OUTCOMES Primary outcomes are maximum treadmill test duration (seconds) and perceived exertion (Modified Borg Scale, 0-10), measured immediately after each test. Secondary outcomes - blood pressure, heart rate, SpO₂, respiratory rate, and rate-pressure product - are measured at baseline and immediately post-test.

STATISTICAL ANALYSIS Data normality will be assessed using the Shapiro-Wilk test (n<50). Paired t-test or Wilcoxon signed-rank test will be applied depending on data distribution. Sample size was calculated for a crossover design (two-tailed, α=0.05, power=80%, dz=0.8), yielding 23 participants; 28 will be recruited assuming 20% dropout.

CO-INVESTIGATORS:

Monserrat Delgado Valverde, Monserrat Orellana Morales, Emily Quiñileo Riffo, and Sergio Silva Valverde (Escuala de Kinesiología, Universidad de Santiago de Chile). Claudia Román Ureta, Paulina Castro Olivares (Complejo Hospitalario San José).

SETTING Cardiovascular rehabilitation program, Complejo Hospitalario San José, Independencia, Santiago, Chile.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8380418

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older
  • Medical diagnosis of heart failure (documented in clinical record or referral)
  • Electrocardiogram performed within the last 6 months
  • Functional capacity class II or III according to the New York Heart Association (NYHA) classification
  • Stable pharmacological treatment
  • Stable and controlled comorbidities
  • Available to complete two evaluation sessions
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Diagnosis of respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary hypertension)
  • Myocardial infarction within the past 3 months
  • Hospitalization due to heart failure within the past 4 weeks
  • Cognitive impairment or inability to follow the study protocol
  • Neuromuscular or osteoarticular conditions that limit treadmill test performance

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HFNC (Experimental)
Participants will perform an incremental treadmill test while using high-flow nasal cannula (HFNC) via AIRVO 2™ device with a nasal cannula at 50-60 L/min, FiO₂ 0.21, and temperature set at 34-37°C according to participant comfort. An acclimatization period will be performed before the test, increasing flow by 10 L/min every 5-10 minutes until reaching the target flow.
HFNC delivered via AIRVO 2™ (Fisher & Paykel Healthcare, Auckland, New Zealand) with a nasal cannula at 50-60 L/min, FiO₂ 0.21, temperature 34-37°C. The cannula is removed immediately after the test is completed.
Ingen indgriben: No HFNC (Control)
Participants will perform an incremental treadmill test without any ventilatory support device.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum treadmill test duration
Tidsramme: Immediately after each test session (up to 24 minutes)
Maximum time achieved by the participant during the incremental treadmill test, measured in seconds.
Immediately after each test session (up to 24 minutes)
Perceived exertion
Tidsramme: Immediately after each test session
Participant's subjective perception of effort measured using the Modified Borg Scale (0-10), where 0 is nothing at all and 10 is extremely heavy.
Immediately after each test session

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart rate
Tidsramme: Baseline and immediately after each test session
Heart rate measured in beats per minute using pulse oximetry.
Baseline and immediately after each test session
Blood pressure
Tidsramme: Baseline and immediately after each test session.
Systolic and diastolic blood pressure measured in mmHg using a sphygmomanometer.
Baseline and immediately after each test session.
Oxygen saturation
Tidsramme: Baseline and immediately after each test session.
Peripheral oxygen saturation (SpO₂) measured as a percentage using pulse oximetry.
Baseline and immediately after each test session.
Respiratory rate
Tidsramme: Baseline and immediately after each test session.
Respiratory rate measured in breaths per minute using a vital signs monitor.
Baseline and immediately after each test session.
Rate-pressure product
Tidsramme: Baseline and immediately after each test session.
Calculated as systolic blood pressure multiplied by heart rate (mmHg × beats/min), used as an indirect indicator of myocardial oxygen demand.
Baseline and immediately after each test session.

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared during the study period. Data will be stored on a password-protected server at Universidad de Santiago de Chile for 5 years after study completion. Only anonymized data, with no information that could identify participants, may be deposited in a public repository after the custody period ends. Any future use of the data will require a specific and separate consent process.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hjertefejl

Kliniske forsøg med High-Flow Nasal Cannula (HFNC)

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