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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.

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 data supports the effectiveness of the treatment Inspiratory Muscle Training for heart rehabilitation?

Research shows that Inspiratory Muscle Training (IMT) can improve respiratory muscle strength and quality of life in patients with heart failure, suggesting it may be beneficial for heart rehabilitation. ^{1 2 3 4 5}

Is inspiratory muscle training safe for humans?

Inspiratory muscle training (IMT) has been widely used in both healthy individuals and those with various health conditions, and it is generally considered safe for improving respiratory muscle strength and other health parameters. ^{1 2 6 7 8}

How does breathing muscle training differ from other heart rehabilitation treatments?

Breathing muscle training is unique because it focuses on strengthening the muscles used for breathing, which can improve overall respiratory function and endurance. Unlike other heart rehabilitation treatments that may focus on medication or physical exercise, this approach specifically targets the respiratory muscles to enhance breathing efficiency and potentially improve heart health. ^{1 2 6 7 8}

Research Team

Joshua Smith, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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 over 18, speak English, and don't have major health issues.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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]

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) 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]

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 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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Inspiratory muscle training during pulmonary rehabilitation]. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training in Patients With Heart Failure: What Is New? Systematic Review and Meta-Analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with chronic obstructive pulmonary disease: the state of the evidence. [2022]

5. England 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. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training improves the swimming performance of competitive young male sprint swimmers. [2021]

7. Australia 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The effects of inspiratory muscle training on balance and functional mobility: a systematic review. [2023]