Breathing Muscle Training for Heart Rehabilitation

Overseen By Eric Bruhn, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Uremia, Renal impairment, Liver disease, 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: Unknown

Duration: 12 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether training the muscles used for breathing can improve blood flow and blood pressure during exercise in people with heart failure. Participants will engage in either light or more intense breathing exercises. The trial targets individuals diagnosed with heart failure who are currently in a cardiac rehab program. Additionally, there is a group for healthy individuals without major health issues. Those with heart failure actively participating in cardiac rehab may be well-suited for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance heart failure treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that inspiratory muscle training (IMT) is generally safe and well-tolerated by patients. A review of several studies found that IMT is a safe and practical therapy for people with certain heart conditions, with most individuals not experiencing serious side effects. Another study found that IMT improved muscle strength and heart and lung function in patients who had undergone heart surgery, without causing major problems. Although the safety record is strong, discussing any concerns with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about inspiratory muscle training for heart rehabilitation because it offers a unique approach by strengthening the breathing muscles, which is not typically the focus of standard heart rehab treatments. While most heart rehabilitation programs concentrate on aerobic exercises and medication, this method directly targets the respiratory muscles, potentially improving breathing efficiency and overall cardiovascular function. The approach is non-invasive and can be tailored to individual needs, providing a personalized rehabilitation option that might enhance recovery outcomes for heart patients.

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

Research has shown that inspiratory muscle training (IMT) can improve heart health. Studies have found that IMT strengthens breathing muscles and enhances exercise capacity in people with heart failure. It also boosts quality of life and heart and lung performance, particularly for those undergoing heart surgery. Reviews confirm that IMT is safe, well-tolerated, and beneficial for lung function. In this trial, participants will be assigned to either a sham arm, performing IMT at 2% maximal inspiratory pressure, or a non-sham arm, performing IMT at 40% maximal inspiratory pressure, for 12 weeks. These findings suggest that IMT can be a valuable component of heart rehabilitation. ^{4 6 7 8 9}

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 who speak English. There are two groups: one with heart failure patients eligible for cardiac rehab, and a healthy control group without lung, heart, or other major diseases. Participants must be able to exercise and give consent. Those with liver disease, uremia, iodide allergies, or poor kidney function (creatinine >1.3 mg/dL) can't join.

Inclusion Criteria

I am an adult with heart failure and qualify for cardiac rehab.

Exclusion Criteria

I have heart failure and can't participate in a structured exercise program.

I am able and willing to give informed consent.

I have kidney problems or am allergic to iodides.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform inspiratory muscle training at specified pressures for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inspiratory Muscle Training

Trial Overview

The study tests if breathing muscle training improves blood flow and pressure during exercise when added to standard cardiac rehabilitation in people with heart failure compared to healthy individuals matched by age and sex.

How Is the Trial Designed?

Group I: Non-sham arm Active Control 1 Intervention

Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks.

Group II: Sham arm Placebo Group 1 Intervention

Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

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]

The new inspiratory muscle training and positive expiratory pressure (IMT/PEP) device improved maximal expiratory pressure in older men and showed non-inferiority compared to the Threshold IMT device, confirming its efficacy for respiratory muscle training.

Both home-based and center-based training protocols had high adherence rates (91-99%), suggesting that with proper education, home-based training can be effective for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a new respiratory muscle training device in community-dwelling elderly men: an open-label, randomized, non-inferiority trial. Kim, SH., Shin, MJ., Lee, JM., et al.[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 balance in both healthy and diseased adults, based on a systematic review of 10 randomized control trials.

The effects of IMT on functional mobility were inconclusive, indicating that while balance benefits are clear, more research is needed to understand its impact on overall mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. Sheraz, S., Ferraro, FV., Siddiqui, FA., et al.[2023]

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]

Inspiratory muscle training (IMT) significantly improved inspiratory strength and lung function in young swimmers, with notable increases in the S-Index and maximum inspiratory flow after a four-week program.

Swimmers who underwent IMT showed significantly faster swimming times in 50-m, 100-m, and 200-m events compared to a control group, indicating that enhanced respiratory muscle strength positively impacts swimming performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. Yañez-Sepulveda, R., Alvear-Ordenes, I., Tapia-Guajardo, A., et al.[2021]

Inspiratory muscle training (IMT) has been shown to significantly improve inspiratory muscle function, dyspnea, and health-related quality of life in patients with chronic obstructive pulmonary disease (COPD), based on a review of 15 randomized trials.

High-intensity IMT specifically enhances inspiratory muscle strength, but its effects on other clinical outcomes, such as exercise tolerance, remain unclear, indicating a need for further research to clarify these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with chronic obstructive pulmonary disease: the state of the evidence. Shoemaker, MJ., Donker, S., Lapoe, A.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8435466/

Effectiveness of Inspiratory Muscle Training on Respiratory ...

There is strong evidence that IMT improves inspiratory muscle strength, pulmonary function, and functional capacity, and reduces the length of hospital stay.

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journal-of-cardiology.com

journal-of-cardiology.com/article/S0914-5087(25)00016-4/abstract

The efficacy of inspiratory muscle training in improving ...

Inspiratory muscle training (IMT) has shown improvements in clinical variables for heart failure (HF) patients. We conducted a meta-analysis to investigate if ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0914508725000164

The efficacy of inspiratory muscle training in improving ...

A recent meta-analysis showed IMT significantly improves QoL and respiratory muscle strength as well as exercise capacity in patients with HF [12]. However, the ...

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mdpi.com

mdpi.com/2543-6031/93/3/10

Inspiratory Muscle Training Improved Cardiorespiratory ...

This training has been shown to effectively improve inspiratory muscle strength and cardiorespiratory performance in patients undergoing open heart surgery.

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frontiersin.org

frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.999422/full

Effectiveness and safety of inspiratory muscle training in ...

This systematic review and meta-analysis showed that IMT is a safe, feasible, and well-tolerated physical therapy in PH patients. Furthermore, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12189406/

Inspiratory Muscle Training Improved Cardiorespiratory ...

This training has been shown to effectively improve inspiratory muscle strength and cardiorespiratory performance in patients undergoing open heart surgery.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07108231

Inspiratory Muscle Training in Hospitalized Heart Failure ...

This study aims to evaluate the effects of IMT on inspiratory muscle strength, hemodynamic and functional outcomes, as well as the safety of the ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S003306202100116X

Inspiratory muscle weakness in cardiovascular diseases

Inspiratory muscle dysfunction, which encompasses a loss in muscle mass and/or pressure generating capacity, occurs in up to ~40% of patients with chronic ...

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mdpi.com

mdpi.com/2673-3846/5/1/6

Inspiratory Muscle Training Intensity in Patients Living with ...

The purpose of this study was to review the impact of IMT intensity on respiratory muscle strength, functional and exercise capacity, pulmonary function, and ...