About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
High-Flow Nasal Cannula (HFNC)
DeviceHFNC 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.
Treatment groups
Trial outcomes
Primary outcomes
Maximum treadmill test duration
Maximum time achieved by the participant during the incremental treadmill test, measured in seconds
Perceived exertion
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
Secondary outcomes
Heart rate
Heart rate measured in beats per minute using pulse oximetry
Blood pressure
Systolic and diastolic blood pressure measured in mmHg using a sphygmomanometer
Oxygen saturation
Peripheral oxygen saturation (SpO₂) measured as a percentage using pulse oximetry
Respiratory rate
Respiratory rate measured in breaths per minute using a vital signs monitor
Sponsors and contacts
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