Breathing muscle training may boost heart failure recovery
NCT ID NCT07688863
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This study tests whether strengthening the muscles used for breathing can improve exercise capacity, heart function, and quality of life in people with chronic heart failure. Participants with reduced or mildly reduced heart pumping ability will be randomly assigned to one of two types of breathing muscle trainers or a low-intensity sham device. Over 8 weeks, researchers will measure changes in breathing strength, oxygen use during exercise, and daily well-being to see which approach works best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inspiratory muscle training devices (mechanical pressure-threshold and electronic flow-resistive)
- What this could lead to
- If effective, this training could become a standard part of cardiac rehab to help heart failure patients breathe easier, exercise more, and feel better day-to-day.
- What could go wrong
- This is a small, early-stage study (60 people) comparing device types. The sham group still does low-intensity breathing, so the real benefit over minimal training may be modest. Results may not apply to all heart failure patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Documented clinical diagnosis of chronic Heart Failure with Reduced Ejection Fraction (HFrEF) according to the European Society of Cardiology (ESC) guidelines. 2. Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% documented by echocardiography within the last 12 months. 3. Clinically stable condition for at least 3 months prior to enrollment, with no hospitalizations or major changes in optimized medical therapy. 4. New York Heart Association (NYHA) functional class I to IV. 5. Evidence of inspiratory muscle weakness, defined as a baseline Maximal Inspiratory Pressure (MIP) \< 70% of the predicted value for age and sex. 6. Age greater than or equal to 18 years. 7. Patient must be capable of understanding the protocol instructions and must provide signed written informed consent. Exclusion Criteria: 1. Presence of primary severe pulmonary or respiratory diseases (e.g., Chronic Obstructive Pulmonary Disease \[COPD\] GOLD stage III or IV, active asthma, severe pulmonary hypertension, or restrictive lung disease). 2. Recent myocardial infarction, unstable angina, or coronary artery bypass graft (CABG) surgery within the last 6 months. 3. Severe uncorrected valvular heart disease or complex, uncontrolled ventricular arrhythmias. 4. Orthopedic, neurological, or musculoskeletal limitations that prevent the safe execution of an incremental cardiopulmonary exercise test on a cycle ergometer or the performance of the isometric handgrip protocol. 5. Cognitive impairment or psychological conditions that limit the ability to follow instructions, maintain correct diaphragmatic breathing technique, or properly seal the training device mouthpiece. 6. Current participation in another structured physical rehabilitation or formal sports training program that could confound the systemic results of the intervention. 7. Any acute infectious, inflammatory, or medical condition that, in the investigator's opinion, poses a safety risk during high-intensity training.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Universidad Andrés Bello, Campus Viña del Mar
Viña del Mar, Valparaiso, 2520000, Chile
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