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

Официальное название

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

Обзор

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 (HF) 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? and 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 HF 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.

Подробное описание

Heart failure 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.

Вмешательства

• Устройство High-Flow Nasal Cannula (HFNC)
  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.

Первичные конечные точки

• Maximum treadmill test duration [Срок оценки: Immediately after each test session (up to 24 minutes)]
• Perceived exertion [Срок оценки: Immediately after each test session]

Вторичные конечные точки (5)

• Heart rate [Срок оценки: Baseline and immediately after each test session]
• Blood pressure [Срок оценки: Baseline and immediately after each test session]
• Oxygen saturation [Срок оценки: Baseline and immediately after each test session]
• Respiratory rate [Срок оценки: Baseline and immediately after each test session]
• Rate-pressure product [Срок оценки: Baseline and immediately after each test session]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Чили · 1 центр

• Complejo Hospitalario San José — Santiago

Публикации

• Mazzucco G, Torres-Castro R, Intelangelo L, Lista-Paz A, Escalante JP, Zumeta-Olaskoaga L, Veiga G, Etxarri AA. Is non-invasive ventilation effective in improving the exercise capacity in patients with cardiac heart failure?: A randomised crossover trial. PLoS One. 2025 Jul 7;20(7):e0327399. doi: 10.1371/journal.pone.0327399. eCollection 2025. PMID 40622949
• Fang TP, Chen YH, Hsiao HF, Cho HY, Tsai YH, Huang CC, Hsieh MJ, Wu HP, Lin HL. Effect of high flow nasal cannula on peripheral muscle oxygenation and hemodynamic during paddling exercise in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Ann Transl Med. 2020 Mar;8(6):280. doi: 10.21037/atm.2020.03.87. PMID 32355724
• Candia C, Lombardi C, Merola C, Ambrosino P, D'Anna SE, Vicario A, De Marco S, Molino A, Maniscalco M. The Role of High-Flow Nasal Cannula Oxygen Therapy in Exercise Testing and Pulmonary Rehabilitation: A Review of the Current Literature. J Clin Med. 2023 Dec 30;13(1):232. doi: 10.3390/jcm13010232. PMID 38202239
• Chua MT, Kuan WS. The use of high-flow nasal cannula in acute decompensated heart failure. J Emerg Crit Care Med. 2017;1:22. doi:10.21037/jeccm.2017.08.06
• Carvalho LA, Brandao DC, Campos SL, Vidal TMS, Remigio MI, Martins SM, Dornelas de Andrade A. Noninvasive Ventilation Before Maximum Exercise Test Increases Exercise Tolerance in Subjects With Heart Failure: A Crossover Study. Arch Phys Med Rehabil. 2017 May;98(5):849-855. doi: 10.1016/j.apmr.2016.09.129. Epub 2016 Oct 26. PMID 27794485
• Gao H, Chen L, Kang X. High-flow nasal cannula oxygen therapy in patients with acute heart failure: a meta-analysis. J Nurse Pract. 2023;19(5):104602. doi:10.1016/j.nurpra.2023.104602
• Tremblay-Gravel M, Nozza A, Glezer S, Kamada A, Boulet J, Parent MC, Giraldeau G, Racine N, Nigam A, Cloutier I, Pierre R, Rouleau JL, O'Meara E, Ducharme A, Tardif JC. Oxygen supplementation in ambulatory patients with heart failure: a randomized proof-of-concept study. Eur Heart J Open. 2025 Jun 11;5(3):oeaf074. doi: 10.1093/ehjopen/oeaf074. eCollection 2025 May. PMID 40584583
• Buchfuhrer MJ, Hansen JE, Robinson TE, Sue DY, Wasserman K, Whipp BJ. Optimizing the exercise protocol for cardiopulmonary assessment. J Appl Physiol Respir Environ Exerc Physiol. 1983 Nov;55(5):1558-64. doi: 10.1152/jappl.1983.55.5.1558. PMID 6643191

Идентификаторы

NCT: NCT07613762 · NIC 23-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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