Inspiratory Muscle Training for Heart Failure

Overseen By Eric Bruhn, M.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: SGLT2 inhibitors, Spironolactone

Disqualifiers: Ventricular tachycardia, Heart block, Smoking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specific breathing exercise, called inspiratory muscle training, can help people with heart failure improve their breathing during exercise. Participants will perform this exercise at either high or very low intensity for comparison. Individuals experiencing heart failure symptoms, taking specific heart failure medications, and able to exercise without major physical limitations might be suitable for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative approaches to managing heart failure symptoms.

Do I need to stop my current medications for the trial?

The trial requires participants to have been taking SGLT2 inhibitors and spironolactone (and beta-blockers for certain patients) for more than 3 months, so you will need to continue these medications. The protocol does not specify if you need to stop any other medications.

What prior data suggests that inspiratory muscle training is safe for heart failure patients?

Research has shown that Inspiratory Muscle Training (IMT) is generally safe for people with heart failure. Studies have found that IMT can improve breathing and increase exercise capacity without causing serious side effects. People with chronic heart failure who used IMT reported easier exercise and felt less tired and out of breath.

Additionally, no major negative effects have been commonly linked to IMT, indicating that patients tolerate it well. Those considering joining a trial should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Inspiratory Muscle Training (IMT) is unique because it strengthens the muscles used for breathing, unlike traditional heart failure treatments that focus on medications like ACE inhibitors, beta-blockers, or diuretics to manage symptoms and improve heart function. Researchers are excited about IMT because it directly enhances respiratory muscle strength, potentially improving patient endurance and quality of life. This non-drug approach offers a promising complementary option to existing therapies, addressing a different aspect of heart failure management by focusing on breathing efficiency.

What evidence suggests that inspiratory muscle training is effective for heart failure?

Research has shown that inspiratory muscle training (IMT) can help people with heart failure. In this trial, participants will divide into two groups: one receiving IMT at 40% maximal inspiratory pressure and another receiving a sham treatment at 2% maximal inspiratory pressure. Studies have found that IMT strengthens breathing muscles and improves the quality of life for these patients. It also lowers certain heart-related markers, indicating better heart health. Other research suggests that IMT improves blood flow to both resting and active limbs in people with chronic heart failure, potentially aiding circulation during physical activity. Overall, promising evidence indicates that IMT can benefit heart failure patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Joshua Smith, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who can exercise, have a BMI ≤40 kg/m2, and are non-smokers or have quit smoking with less than a 20 pack-year history. They must be on certain heart medications for more than 3 months. Pregnant women, current heavy smokers, those with severe asthma or liver issues, and individuals with recent serious heart rhythm problems cannot join.

Inclusion Criteria

Able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise)

I have been on SGLT2 inhibitors and spironolactone for over 3 months.

Body mass index ≤40 kg/m2

Exclusion Criteria

Pregnant women (testing will be done by research team if requested)

I have asthma with severe attacks and don't always notice when my breathing is bad.

I currently smoke or have smoked more than 20 pack-years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inspiratory muscle training at specified intensities for 8 weeks

8 weeks

7 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inspiratory Muscle Training

Trial Overview

The study tests how training the muscles used for breathing affects their function during exercise in patients with heart failure. Participants will undergo inspiratory muscle training to see if it improves their ability to breathe when active.

How Is the Trial Designed?

Group I: Inspiratory muscle training (IMT) group Experimental Treatment 1 Intervention

IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.

Group II: SHAM group Placebo Group 1 Intervention

IMT performed at 2% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.

Inspiratory Muscle Training is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Inspiratory Muscle Training for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive Heart Failure
• Spinal Cord Injury
• Multiple Sclerosis

Approved in United States as Inspiratory Muscle Training for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive Heart Failure
• Spinal Cord Injury
• Multiple Sclerosis
• Cardiac Rehabilitation

Approved in Canada as Inspiratory Muscle Training for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive Heart Failure
• Spinal Cord Injury
• Multiple Sclerosis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study involving 40 critically ill patients showed that using an electronic device for inspiratory muscle training (IMT) was feasible, with 81% of planned sessions completed, indicating good adherence to the intervention.

The electronic IMT was found to be safe, with no major adverse events and only 10% minor adverse events that were transient and without clinical consequences, while over 85% of participants reported it as helpful for their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and patient acceptability of electronic inspiratory muscle training in patients who require prolonged mechanical ventilation in the intensive care unit: A dual-centre observational study. Nickels, M., Erwin, K., McMurray, G., et al.[2023]

Inspiratory muscle training (IMT) significantly improved inspiratory strength and endurance in patients with chronic heart failure (CHF), as evidenced by increased maximum inspiratory pressure and sustained maximal inspiratory pressure after 10 weeks of training.

Patients undergoing IMT also experienced enhanced exercise capacity, reduced dyspnea, and improved quality of life, demonstrating the efficacy of this intervention in managing symptoms of CHF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training using an incremental endurance test alleviates dyspnea and improves functional status in patients with chronic heart failure. Laoutaris, I., Dritsas, A., Brown, MD., et al.[2019]

High-intensity inspiratory muscle training (HIIMT) significantly improves exercise capacity and respiratory muscle strength in patients with heart failure with reduced ejection fraction (HFrEF), based on a review of five studies involving 138 patients.

HIIMT led to measurable improvements in VO2peak, walking tests, and maximal inspiratory pressure, indicating its efficacy as a beneficial intervention for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of high-intensity inspiratory muscle training on exercise capacity and inspiratory muscle strength in heart failure with reduced ejection fraction: a systematic review and meta-analysis. Gomes Neto, M., Ferrari, F., Helal, L., et al.[2019]

Inspiratory muscle training (IMT) has shown beneficial effects on respiratory health in both healthy individuals and those with diseases, highlighting its potential as a therapeutic intervention.

The article aims to compare different IMT methods and their outcomes, specifically focusing on the Test of Incremental Respiratory Endurance (TIRE), which could help identify the most effective training approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel methods of inspiratory muscle training via the Test of Incremental Respiratory Endurance (TIRE). Cahalin, LP., Arena, R.[2022]

Inspiratory muscle training (IMT) improves the strength and endurance of inspiratory muscles, reduces dyspnoea during daily activities, and enhances quality of life, but does not offer additional benefits when combined with standard pulmonary rehabilitation programs.

IMT is beneficial for patients who cannot engage in full exercise training, and it shows promise in pre-operative programs, suggesting it may be a useful intervention in specific contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. Beaumont, M., Le Tallec, F., Villiot-Danger, E.[2021]

Inspiratory muscle training (IMT) significantly improves respiratory muscle strength, functional capacity, and reduces dyspnea in patients with stable heart failure, based on a review of 12 clinical trials.

Typical IMT protocols involved daily sessions lasting 20 to 30 minutes at an intensity greater than 30% of maximal inspiratory pressure, leading to moderate to large effect sizes in key outcomes like inspiratory pressure and walking distance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with heart failure: a systematic review. Lin, SJ., McElfresh, J., Hall, B., et al.[2021]

Inspiratory muscle training (IMT) combined with pulmonary rehabilitation (PR) did not show significant improvements in dyspnea, functional exercise capacity, or health-related quality of life in COPD patients, based on a review of 55 randomized controlled trials involving 4,467 participants.

However, IMT alone may lead to better outcomes in these areas, suggesting that while IMT can be beneficial, its effectiveness may be diminished when combined with PR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Ammous, O., Feki, W., Lotfi, T., et al.[2023]

Isolated inspiratory muscle training (IMT) significantly improves inspiratory muscle strength, functional capacity (measured by the 6-Minute Walk Test), and quality of life in patients with heart failure, based on a systematic review of 14 studies.

IMT is particularly beneficial for patients with inspiratory muscle weakness, and higher training loads and longer intervention times lead to greater improvements, making it a valuable adjuvant therapy for those unable to participate in conventional rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training in Patients With Heart Failure: What Is New? Systematic Review and Meta-Analysis. Azambuja, ACM., de Oliveira, LZ., Sbruzzi, G.[2021]

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