RecruitingNot Applicable

Inspiratory Muscle Training in Hospitalized Heart Failure Patients

Brazil30 participantsStarted 2026-05-13

Plain-language summary

Introduction Exercise intolerance is the most common symptom in patients with heart failure (HF), significantly impacting their quality of life and functional capacity. Muscle metabolism may be impaired due to sympathetic hyperactivation, systemic inflammation, and neurohormonal alterations, contributing to ventilatory inefficiency and exercise intolerance. Inspiratory muscle training (IMT) has been shown to improve inspiratory muscle strength and endurance, reducing fatigue and the sensation of dyspnea. There is a gap in the evidence regarding the use of IMT in hospitalized settings, particularly concerning short-term gains in inspiratory muscle strength and the safety of the intervention. This study aims to evaluate the effects of IMT on inspiratory muscle strength, hemodynamic and functional outcomes, as well as the safety of the IMT protocol in hospitalized patients with HF. Methods A randomized, controlled clinical trial will be conducted in the Cardiac Intensive Care Unit of the University Hospital Pedro Ernesto. The study will include individuals of both sexes, aged 18 years or older, who are hospitalized due to heart failure. Exclusion criteria will include: pregnancy; head trauma and/or brain injury; motor disability; signs and/or symptoms of low cardiac output; acute coronary syndrome; advanced HF with left ventricular ejection fraction (LVEF) below 20%; presence of untreated tachyarrhythmias or bradyarrhythmias; use of high-dose inotropes or vasopressors or an increase in their dose within the past 24 hours. Primary outcomes will include inspiratory muscle strength, safety, functional status, length of stay in the ICU, and hospital readmission within 90 days. After randomization, the intervention group will undergo IMT with a load between 30% and 50% of maximal inspiratory pressure (MIP), while the control group will perform IMT without load. It is expected that IMT will be safe and lead to improvements in inspiratory muscle strength and functional status, without significant hemodynamic repercussions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of heart failure; * age over 18 years; * hospital admission due to heart failure; * clinical and hemodynamic stability defined as: heart rate \> 40 bpm and \< 130 bpm; systolic blood pressure (SBP) \> 90 mmHg and \< 180 mmHg; mean arterial pressure (MAP) \> 60 mmHg and \< 110 mmHg; respiratory rate \> 5 breaths per minute and \< 40 breaths per minute; peripheral oxygen saturation \> 88%; absence of psychomotor agitation or somnolence Exclusion Criteria: * pregnancy; * head trauma and/or brain injury; * motor incapacity preventing participation in the institutional rehabilitation protocol of the Cardiointensive Care Unit (ICU); * signs and/or symptoms of low cardiac output (such as sweating, hypotension, hyperlactatemia, nausea); * acute coronary syndrome; * advanced heart failure with left ventricular ejection fraction (LVEF) less than 20% * presence of untreated tachyarrhythmias or bradyarrhythmias; * use of inotropes or vasopressors at high doses or dose escalation in the last 24 hours (dobutamine above 15 mcg/kg/min, milrinone above 0.5 mcg/kg/min, norepinephrine above 0.3 mcg/kg/min).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

inspiratory muscle strenght

Timeframe: Day 1, after 7 days of admission, through study completion, an average of 10 days

Trial details

NCT IDNCT07108231

SponsorCAROLINA NIGRO DI LEONE

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10-01

Contact for this trial

Carolina N DI LEONE, Master degree reseacher

+5521998043470 caroll_nigro@hotmail.com

View on ClinicalTrials.gov More Heart Failure trials