- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07613762
High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation
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 (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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Manuel A Gálvez, MSc
- Telefonní číslo: +56 9 4229 3780
- E-mail: manuel.galvez.r@usach.cl
Studijní místa
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 8380418
- Complejo Hospitalario San José
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Kontakt:
- Claudia Román, MPH
- Telefonní číslo: 280019 +56225680000
- E-mail: claudia.roman@redsalud.gob.cl
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
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Žádný zásah: No HFNC (Control)
Participants will perform an incremental treadmill test without any ventilatory support device.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maximum treadmill test duration
Časové okno: Immediately after each test session (up to 24 minutes)
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Maximum time achieved by the participant during the incremental treadmill test, measured in seconds
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Immediately after each test session (up to 24 minutes)
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Perceived exertion
Časové okno: Immediately after each test session
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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
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Immediately after each test session
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Heart rate
Časové okno: Baseline and immediately after each test session
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Heart rate measured in beats per minute using pulse oximetry
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Baseline and immediately after each test session
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Blood pressure
Časové okno: Baseline and immediately after each test session
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Systolic and diastolic blood pressure measured in mmHg using a sphygmomanometer
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Baseline and immediately after each test session
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Oxygen saturation
Časové okno: Baseline and immediately after each test session
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Peripheral oxygen saturation (SpO₂) measured as a percentage using pulse oximetry
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Baseline and immediately after each test session
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Respiratory rate
Časové okno: Baseline and immediately after each test session
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Respiratory rate measured in breaths per minute using a vital signs monitor
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Baseline and immediately after each test session
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Rate-pressure product
Časové okno: Baseline and immediately after each test session
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Calculated as systolic blood pressure multiplied by heart rate (mmHg × beats/min), used as an indirect indicator of myocardial oxygen demand
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Baseline and immediately after each test session
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
- Bozkurt B, Fonarow GC, Goldberg LR, Guglin M, Josephson RA, Forman DE, Lin G, Lindenfeld J, O'Connor C, Panjrath G, Pina IL, Shah T, Sinha SS, Wolfel E; ACC's Heart Failure and Transplant Section and Leadership Council. Cardiac Rehabilitation for Patients With Heart Failure: JACC Expert Panel. J Am Coll Cardiol. 2021 Mar 23;77(11):1454-1469. doi: 10.1016/j.jacc.2021.01.030.
- Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.
- Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
- Morris BA, Sinaei R, Smart NA. Resistance is not futile: a systematic review of the benefits, mechanisms and safety of resistance training in people with heart failure. Heart Fail Rev. 2024 Jul;29(4):827-839. doi: 10.1007/s10741-024-10402-0. Epub 2024 Apr 15.
- Dell'Era S, Roux N, Gimeno-Santos E, Terrasa S. The High Flow Nasal Cannula Improves the Exercise Capacity in Patients with COPD: Randomized, Crossover Clinical Trial. Rev Am Med Respir. 2019;19(1):16-26.
- Li J, Scott JB, Fink JB, Reed B, Roca O, Dhand R. Optimizing high-flow nasal cannula flow settings in adult hypoxemic patients based on peak inspiratory flow during tidal breathing. Ann Intensive Care. 2021 Nov 27;11(1):164. doi: 10.1186/s13613-021-00949-8.
- Dibben GO, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease: a meta-analysis. Eur Heart J. 2023 Feb 7;44(6):452-469. doi: 10.1093/eurheartj/ehac747.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Sociedad Chilena de Cardiología y Cirugía Vascular, Ministerio de Salud. Insuficiencia cardíaca. Santiago (Chile); 2015. 96 p.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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