IMST for Coronary Heart Disease

(BREATHE Trial)

Overseen By Benjamin Chow, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Unstable angina, Severe valvular heart disease, COPD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a breathing exercise called inspiratory muscle strength training (IMST) to determine if it can aid individuals with coronary artery disease (CAD) by enhancing blood flow to the heart. Researchers will compare high-intensity and low-intensity IMST to identify which is more effective. Individuals stable on their medications for at least a month and capable of performing breathing exercises may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance heart health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must have had no changes in your medications for the past month to participate.

What prior data suggests that high-intensity IMST is safe for patients with coronary artery disease?

Research shows that high-intensity inspiratory muscle training (IMST) is generally safe and well-tolerated. Studies have found that it strengthens and improves the endurance of breathing muscles without causing serious side effects. For individuals with heart conditions, such as coronary artery disease, this training has improved breathing.

While studies do not report major negative effects, this training is often used alongside other heart treatments. This indicates it is safe enough to be part of a larger treatment plan for heart patients. Therefore, for those considering joining a trial for high-intensity IMST, research supports its safety in enhancing heart and lung function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about IMST (Inspiratory Muscle Strength Training) for coronary heart disease because it offers a novel, non-pharmacological approach to improving heart health. Unlike standard treatments that often rely on medications or invasive procedures, IMST focuses on strengthening the respiratory muscles, potentially enhancing cardiovascular function with just a small, portable device. This method could offer a low-cost, accessible way for patients to manage their condition with fewer side effects and a more convenient treatment regimen. High-intensity IMST, in particular, is being explored for its potential to deliver significant benefits in a shorter time compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

Research has shown that high-intensity inspiratory muscle strength training (IMST), which participants in this trial may receive, can improve heart health. In earlier studies, high-intensity IMST strengthened breathing muscles and increased their endurance, while also helping the heart manage stress more effectively. Although both high and low-intensity IMST, which this trial compares, have proven beneficial, high-intensity IMST is particularly noted for its potential to enhance heart health. Inspiratory muscle training is considered an effective method for assisting individuals with heart problems. ^{1 2 4 6 7}

Who Is on the Research Team?

Benjamin Chow, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can do respiratory exercise tests and are stable, including no medication changes in the last month. They must be referred to PET at the University of Ottawa Heart Institute with coronary artery disease but without severe non-cardiac issues, unstable angina, severe valvular heart disease, hypertrophic cardiomyopathy or COPD.

Inclusion Criteria

You can do a breathing test.

Patients who are referred for a PET scan at the University of Ottawa Heart Institute.

My medications have been the same for the last month.

Exclusion Criteria

I don't have major health issues that could affect my survival during the study.

I cannot follow instructions for training or breathing exercises.

I cannot come back for follow-up visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 8 weeks of high-intensity or low-intensity inspiratory muscle strength training (IMST)

8 weeks

Follow-up

Participants are monitored for changes in coronary blood flow and other health metrics after IMST

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-intensity IMST
• Low-intensity IMST

Trial Overview The study compares high-intensity versus low-intensity inspiratory muscle strength training (IMST) on improving blood flow in heart arteries among patients with coronary artery disease. It's a double-blind trial where neither participants nor researchers know who gets which intensity level until after results are collected.

How Is the Trial Designed?

Group I: High-intensity IMST Active Control 1 Intervention

Participants who will be trained with high-intensity IMST

Group II: Low-intensity IMST Placebo Group 1 Intervention

Participants who will be trained with low-intensity IMST

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

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 strength training (IMST) was successfully adapted for two infants with congenital heart disease, leading to improved inspiratory muscle performance and successful weaning from mechanical ventilation without any adverse events.

Both infants showed significant improvements in maximal inspiratory pressure and breathing patterns, allowing them to transition to high-flow nasal cannula without needing reintubation during their hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle strength training in infants with congenital heart disease and prolonged mechanical ventilation: a case report. Smith, BK., Bleiweis, MS., Neel, CR., et al.[2021]

This study is a randomized controlled trial involving 60 participants with acute myocardial infarction (AMI) who underwent primary percutaneous coronary intervention (PCI), aiming to assess the feasibility and potential benefits of inspiratory muscle training (IMT) in reducing pneumonia risk.

Participants in the IMT group will train for 15 minutes twice daily for up to 30 days post-PCI, with the primary focus on improving inspiratory muscle strength and secondary outcomes including pneumonia incidence and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of Inspiratory Muscle Training for Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Study Protocol for a Randomized Controlled Trial. Liu, Y., Dai, Y., Liu, Z., et al.[2021]

Inspiratory muscle strength training (IMST) significantly increases maximal inspiratory pressure and reduces dyspnea in both older adults without COPD and those with COPD, demonstrating its efficacy as a respiratory intervention.

IMST particularly enhances functional status and quality of life in older adults without COPD, suggesting that this training can benefit a broader population beyond just COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. Huang, CH., Yang, GG., Wu, YT., et al.[2016]

A 4-week high-intensity inspiratory muscle training (hi-IMT) program significantly improved inspiratory muscle strength by 57.2% and endurance by 72.7% in patients with chronic heart failure, compared to much lower improvements in the control group.

The study, involving 22 patients, demonstrated that hi-IMT is a safe and feasible intervention with no adverse effects, highlighting its potential as an effective therapy for respiratory muscle dysfunction in chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. Marco, E., Ramírez-Sarmiento, AL., Coloma, A., et al.[2020]

High-intensity inspiratory muscle training (IMT) significantly improved inspiratory muscle strength (IMS), inspiratory muscle endurance (IME), and peak power in recreational cyclists over 11 weeks, compared to a sham group.

However, the benefits of high-intensity IMT were not superior to those achieved with moderate-intensity IMT, as both training intensities led to similar improvements in performance without increasing oxygen uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate- and High-Intensity Inspiratory Muscle Training Equally Improves Inspiratory Muscle Strength and Endurance-A Double-Blind Randomized Controlled Trial. Rehder-Santos, P., Abreu, RM., Signini, ÉF., et al.[2022]

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]

In a study of 24 patients who underwent coronary artery bypass grafting (CABG), both high-intensity inspiratory muscle training (IMT) combined with aerobic exercise and aerobic exercise alone improved physical capacity, respiratory muscle strength, and quality of life, as measured by various tests.

However, there were no significant differences in outcomes between the two groups, suggesting that adding IMT to aerobic exercise does not provide additional benefits and may lead to unnecessary costs in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of High-Intensity Inspiratory Muscle Training Associated with Aerobic Exercise in Patients Undergoing CABG: Randomized Clinical Trial. Miozzo, AP., Stein, C., Marcolino, MZ., et al.[2019]

This systematic review aims to evaluate the efficacy of inspiratory muscle training (IMT) in patients with coronary artery disease (CAD) by analyzing randomized controlled trials, focusing on outcomes like quality of life and exercise capacity.

The review will help determine if IMT can be established as an alternative exercise training method for CAD treatment, potentially enhancing patient health and safety through improved respiratory muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of inspiratory muscle training in patients with coronary artery disease: Protocol for a systematic review and meta-analysis. Kadoya, Y., Balamane, S., Visintini, S., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37285766/

Effects of high intensity interval-based inspiratory muscle ... Conclusions: H-IMT is an effective protocol for improving cardiac autonomic function, arterial stiffness, inspiratory and quadriceps muscle ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02885077

Effects of High-intensity Inspiratory Muscle Training in ... EXPECTED RESULTS: The high intensity IMT potentiates the effects of cardiac rehabilitation (phase II) after coronary artery bypass surgery patients. Official ...

3. withpower.com withpower.com/trial/phase-respiratory-aspiration-1-2023-6eb7f

IMST for Coronary Heart Disease (BREATHE Trial) High-intensity inspiratory muscle training (IMT) significantly improved inspiratory muscle strength (IMS), inspiratory muscle endurance (IME), and peak ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6122761/

Effects of High-Intensity Inspiratory Muscle Training ... There was an improvement of all outcomes in both groups, but high-intensity IMT was not able to provide additional benefit in most of the outcomes, being ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0289287

The efficacy of inspiratory muscle training in patients with ... Inspiratory muscle training (IMT) has been recognized as an effective form of training in patients with cardiovascular disease and heart failure.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11677675/

to High-Intensity Inspiratory Muscle Training in Patients ... Inspiratory muscle training has been found to be beneficial in improving respiratory muscle function in critically ill patients and patients with heart failure.

7. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-03385-z

Effectiveness of high-intensity inspiratory muscle training, and ... This study will provide evidence on the effects of H-IMT and combined exercise interventions for individuals with COPD in a community setting.