Heart FailureIMTHHFNCT07108231
Inspiratory Muscle Training in Hospitalized Heart Failure Patients
A study testing Inspiratory muscle trainning in people with Heart Failure and Inspiratory Capacity, run by CAROLINA NIGRO DI LEONE at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Inspiratory Capacity, Inspiratory Muscle Strength
- What is being tested?
- Inspiratory muscle trainning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesBrazil
- Study dates
- 13 May 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Carolina Nigro Di Leone
Rio de Janeiro, Rio de Janeiro
Carolina DI LEONE, +5521998043470, caroll_nigro@hotmail.com
- Recruiting
Pedro Ernesto University Hospital
Rio de Janeiro, Rio de Janeiro
Carolina Di Leone, Master degree, 55 21 998043470, dlnigrocarol@gmail.com
Luiz Fernando Rodrigues Junior, PHD
About this study
Official title: Effects of Inspiratory Muscle Training on Inspiratory Muscle Strength in Hospitalized Heart Failure Patients: A Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
In hospitalized patients, the use of inspiratory muscle training (IMT) may be particularly beneficial to mitigate muscle strength loss caused by hospitalization, reduce length of stay, and optimize the transition to post-discharge rehabilitation. Thus, the implementation of IMT in the hospital setting can be a safe intervention capable of improving the functional capacity of patients with heart failure.
Despite the known benefits, to date there are no studies conducted with heart failure patients admitted to intensive care units that evaluate gains in inspiratory muscle strength and their hemodynamic and functional effects.
After recruitment, patients will be randomized (using the website random.org) into an Intervention group, which will perform inspiratory muscle training (IMT), and a Control group, which will perform a sham IMT (IMTsham). Both groups will follow the institutional ICU rehabilitation protocol.
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 between 30% and 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 with a proposed weekly load increase according to patient tolerance.
For training load progression, patient effort will be considered, aiming to maintain a perceived exertion level between light and moderate fatigue (BORG scale less than 4).
- Being tested
- Inspiratory muscle trainning, Sham (No Treatment)
- Keywords
- HEART FAILURE, EXERCISE INTOLERANCE, INSPIRATORY MUSCLE TRAINNING, HOSPITALIZATION
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainningDevice
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
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.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION | Experimental | IMT group Receives: Device: Inspiratory muscle trainning |
| control | Sham comparator | Sham Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, after 7 days of admission, through study completion, an average of 10 days
Secondary outcomes (3)
Assessment of Functional Status
For the assessment of functional status, the 1-minute sit-to-stand test (1MSTS) will be performed. Participants will be instructed to stand up and sit down as quickly as possible without using their arms for 1 minute and will be advised to stop whenever they wish, if necessary. Heart rate (HR), respiratory rate (RR), blood pressure (BP), peripheral oxygen saturation (SpO2), and assessments of dyspnea and leg fatigue using the Modified Borg Scale will be recorded before and after the test. One repetition is defined as standing up fully straight and returning to a seated position.
Measured: Admission day, through study completion, an average of 10 days
Peripheral Muscle Strength
Peripheral muscle strength (PMS) will be measured using a digital dynamometer (Digital Dynamometer MG4800). Volunteers will perform the maneuver seated at a 90-degree angle, with the elbow flexed at 90 degrees and the wrist in a neutral position. They will be instructed and encouraged to perform a maximal handgrip contraction for 3 seconds on both sides. Three maximal isometric contractions will be performed, and the highest value from the dominant hand will be used for analysis . Predicted normal values will be based on the reference equation for dominant upper limb grip strength in middle-aged and elderly Brazilians. Values below 70% of the predicted will be considered reduced peripheral muscle strength .
Measured: Admission day and through study completion, an average of 10 days
Adverse events
The safety of the IMT protocol will be evaluated by monitoring the occurrence of any adverse events during the intervention. Adverse events will be classified as mild, moderate, or severe (Table 1). The control group will also have adverse events recorded. The heterogeneity in the definition of safety criteria and adverse events is a limitation in the literature, due to the lack of standardization in the definitions and naming of adverse events in clinical practice . Mild events are considered transient and do not require clinical intervention. Moderate events cause temporary symptoms that require clinical intervention. Severe events are those that result in permanent sequelae, serious complications, or even life-threatening conditions, such as cardiac arrest, loss of consciousness, and death .During the intervention period, hemodynamic effects of IMT will be assessed by monitoring vital signs before and after protocol.
Measured: Through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start13 May 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 1 randomized, controlled clinical trial with two arms.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAROLINA NIGRO DI LEONE
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Estado do Rio de Janeiro - UERJ, Instituto Nacional de Cardiologia de Laranjeiras
- Responsible party
- Sponsor-investigator, CAROLINA NIGRO DI LEONE, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108231
- Sponsor's protocol ID
- CAAE:88229525.1.0000.5259
- Acronym
- IMTHHF
- Status last verified
- May 2026
- First submitted
- 9 Jul 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Inspiratory Muscle Strength in Hospitalized Heart Failure Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07108231
- Acronym / sponsor ID
- IMTHHF / CAAE:88229525.1.0000.5259
- Keywords
- HEART FAILURE, EXERCISE INTOLERANCE, INSPIRATORY MUSCLE TRAINNING, HOSPITALIZATION
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CAROLINA NIGRO DI LEONEUniversity, hospital or other
- Collaborators
- Universidade do Estado do Rio de Janeiro - UERJ, Instituto Nacional de Cardiologia de Laranjeiras
- Study start
- 13 May 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In hospitalized patients, the use of inspiratory muscle training (IMT) may be particularly beneficial to mitigate muscle strength loss caused by hospitalization, reduce length of stay, and optimize the transition to post-discharge rehabilitation. Thus, the implementation of IMT in the hospital setting can be a safe intervention capable of improving the functional capacity of patients with heart failure.
Despite the known benefits, to date there are no studies conducted with heart failure patients admitted to intensive care units that evaluate gains in inspiratory muscle strength and their hemodynamic and functional effects.
After recruitment, patients will be randomized (using the website random.org) into an Intervention group, which will perform inspiratory muscle training (IMT), and a Control group, which will perform a sham IMT (IMTsham). Both groups will follow the institutional ICU rehabilitation protocol.
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 between 30% and 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 with a proposed weekly load increase according to patient tolerance.
For training load progression, patient effort will be considered, aiming to maintain a perceived exertion level between light and moderate fatigue (BORG scale less than 4).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a phase 1 randomized, controlled clinical trial with two arms.
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION | Experimental | Device: Inspiratory muscle trainningIMT group |
| control | Sham comparator | Device: Sham (No Treatment)Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainningThe 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 | INTERVENTION |
| Sham (No Treatment)The control group (IMTsham) will perform two daily sessions of 30 repetitions each without any load, using the same resistor device. | Device | control |
Primary outcome
inspiratory muscle strenght
Time frame: Day 1, after 7 days of admission, through study completion, an average of 10 days
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.
3 secondary outcomes
Assessment of Functional Status
Time frame: Admission day, through study completion, an average of 10 days
Peripheral Muscle Strength
Time frame: Admission day and through study completion, an average of 10 days
Adverse events
Time frame: Through study completion, an average of 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle trainning in people with Heart Failure and Inspiratory Capacity, run by CAROLINA NIGRO DI LEONE at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina N DI LEONE, Master degree reseacher (+5521998043470, caroll_nigro@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inspiratory muscle strenght (time frame: Day 1, after 7 days of admission, through study completion, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.