Inspiratory Muscle Training in Hospitalized Heart Failure Patients

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.

Conditions

• Heart Failure
• Inspiratory Capacity
• Inspiratory Muscle Strength
• Hospitalizations

Interventions

DEVICE

Inspiratory muscle trainning

The IMT protocol will involve the use of the Power Breath® linear resistor device, classic light model (Anvisa Registration: 81001390001). The IMT group will perform the protocol with a load ranging from 30% to 50% of maximal inspiratory pressure (MIP). Two daily sessions of 30 repetitions each will be conducted, starting with a minimum load of 30%, with a 10-minute interval between sessions, and a proposed weekly load increase based on patient tolerance. For training load progression, patient effort will be taken into account, aiming to maintain a perceived exertion level between light and moderate fatigue (BORG scale less than 4). Patients will remain seated at a 90° angle, using a nasal clip, and will be encouraged to perform consecutive inspirations with their mouth on the device's mouthpiece. Vital signs-including blood pressure (BP), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2), respiratory rate (RR), heart rate (HR)-and dyspnea sensat

DEVICE

Sham (No Treatment)

The control group (IMTsham) will perform two daily sessions of 30 repetitions each without any load, using the same resistor device.

Sponsors & Collaborators

• CAROLINA NIGRO DI LEONE

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2028-10-01

Completion

2029-10-01

Countries

• Brazil

Study Locations