Inspiratory Muscle Training in Hospitalized Heart Failure Patients

NCT07108231 | Not Yet Recruiting

• 1 other identifier: CAAE:88229525.1.0000.5259
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HEART FAILURE; EXERCISE INTOLERANCE; INSPIRATORY MUSCLE TRAINNING; HOSPITALIZATION

Outcome Measures

Primary Outcomes (1)

• inspiratory muscle strenght

  Inspiratory muscle strength refers to the force generated by the muscles involved in inhalation, primarily the diaphragm and accessory respiratory muscles. It reflects the ability of these muscles to overcome resistance and expand the lungs during breathing. Before the tests to assess static and dynamic inspiratory muscle strength, volunteers underwent a familiarization session with the devices and maneuvers to be performed. After measuring resting hemodynamic parameters, the evaluation of maximal static respiratory pressures was conducted. Maximal inspiratory pressure (MIP) was measured using an analog manovacuometer (MURENAS brand, Anvisa Registration: 80244900005), following the protocol of the American Thoracic Society and the European Respiratory Society. MIP was determined after a maximal inspiratory effort starting from residual volume against airway occlusion.

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

Secondary Outcomes (3)

• Assessment of Functional Status

  Admission day, through study completion, an average of 10 days

• Peripheral Muscle Strength

  Admission day and through study completion, an average of 10 days

• Adverse events

  Through study completion, an average of 10 days

Study Arms (2)

INTERVENTION

EXPERIMENTAL

IMT group

Device: Inspiratory muscle trainning

control

SHAM COMPARATOR

Sham

Device: Sham (No Treatment)

Interventions

Inspiratory muscle trainning DEVICE

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

INTERVENTION

Sham (No Treatment) DEVICE

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

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• CAROLINA NIGRO DI LEONE: lead

Study Sites (1)

Carolina Nigro Di Leone

Rio de Janeiro, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Carolina N DI LEONE, Master degree reseacher

CONTACT

+5521998043470; caroll_nigro@hotmail.com

Luiz F Rodrigues Junior, PhD professor

CONTACT

55 21; luiz.junior@unirio.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead Physiotherapist

Model Details: This is a phase 1 randomized, controlled clinical trial with two arms.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 6, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)