- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Manuel A Gálvez, MSc
- Numer telefonu: +56 9 4229 3780
- E-mail: manuel.galvez.r@usach.cl
Lokalizacje studiów
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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
- Numer telefonu: 280019 +56225680000
- E-mail: claudia.roman@redsalud.gob.cl
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Brak interwencji: No HFNC (Control)
Participants will perform an incremental treadmill test without any ventilatory support device.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Maximum treadmill test duration
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Heart rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- Debost JP, Larsen JT, Munk-Olsen T, Mortensen PB, Meyer U, Petersen L. Joint Effects of Exposure to Prenatal Infection and Peripubertal Psychological Trauma in Schizophrenia. Schizophr Bull. 2017 Jan;43(1):171-179. doi: 10.1093/schbul/sbw083. Epub 2016 Jun 24.
- Wang YY, Yan Q, Huang ZT, Zou Q, Li J, Yuan MH, Wu LQ, Cai ZY. Ameliorating Ribosylation-Induced Amyloid-beta Pathology by Berberine via Inhibiting mTOR/p70S6K Signaling. J Alzheimers Dis. 2021;79(2):833-844. doi: 10.3233/JAD-200995.
- Alpert B, Ferri E, Bennett D, Faverzani M, Fowler J, Giachero A, Hays-Wehle J, Maino M, Nucciotti A, Puiu A, Swetz D, Ullom J. Algorithms for Identification of Nearly-Coincident Events in Calorimetric Sensors. J Low Temp Phys. 2015 Dec 29;184:https://doi.org/10.1007/s10909-015-1402-y.
- 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.
- Baines CP. The mitochondrial permeability transition pore as a target of cardioprotective signaling. Am J Physiol Heart Circ Physiol. 2007 Aug;293(2):H903-4. doi: 10.1152/ajpheart.00575.2007. Epub 2007 May 18. No abstract available.
- Moradi N, Goodyear BG, Sotero RC. Deep EEG source localization via EMD-based fMRI high spatial frequency. PLoS One. 2024 Mar 1;19(3):e0299284. doi: 10.1371/journal.pone.0299284. eCollection 2024.
- Lee JY, Kim M, Jhon M, Kim H, Kang HJ, Ryu S, Kim JM, Kim SW. The association of gratitude with perceived stress among nurses in Korea during COVID-19 outbreak. Arch Psychiatr Nurs. 2021 Dec;35(6):647-652. doi: 10.1016/j.apnu.2021.10.002. Epub 2021 Oct 22.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NIC 23-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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