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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this single-site, parallel-group, double-blind, sham-controlled randomized control trial is to examine the effect of high-intensity inspiratory muscle strength training (IMST) on coronary blood flow assessed using positron emission tomography coronary perfusion imaging in patients with coronary artery disease (CAD). The main question it aims to answer are: • if high-intensity IMST will improve coronary blood flow in patients with CAD, which could be assessed using positron emission tomography coronary perfusion imaging. Participants will be asked to complete the 8-week high-intensity or low-intensity IMST. Researchers will compare high and low-intensity IMST groups to see if coronary blood flow increases after IMST.

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 data supports the effectiveness of the treatment for coronary heart disease?

Inspiratory muscle strength training (IMST) has been shown to improve respiratory muscle strength and quality of life in patients with heart failure and those undergoing coronary artery bypass grafting (CABG). This suggests that IMST could potentially benefit individuals with coronary heart disease by enhancing their respiratory function and overall well-being. ^{1 2 3 4 5}

Is inspiratory muscle training (IMT) safe for humans?

Research indicates that inspiratory muscle training (IMT) is generally safe for humans, including those with heart failure and chronic heart conditions. Studies have evaluated its safety and feasibility, showing no significant adverse effects in these populations. ^{1 5 6 7 8}

How is the treatment IMST for coronary heart disease different from other treatments?

Inspiratory Muscle Strength Training (IMST) is unique because it focuses on strengthening the muscles used for breathing, which can improve respiratory strength and overall physical capacity. Unlike traditional treatments for coronary heart disease that may involve medication or surgery, IMST is a non-invasive exercise-based therapy that can be done at home using a handheld device. ^{1 2 3 4 9}

Research Team

Benjamin Chow, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

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

I am 18 years old or older.

You can do a breathing test.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]

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

Inspiratory muscle strength training in infants with congenital heart disease and prolonged mechanical ventilation: a case report. [2021]

3. Brazil pubmed.ncbi.nlm.nih.gov

Effects of High-Intensity Inspiratory Muscle Training Associated with Aerobic Exercise in Patients Undergoing CABG: Randomized Clinical Trial. [2019]

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

Inspiratory muscle training in patients with heart failure: a systematic review. [2021]

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

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

6. United States 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. [2022]

7. Switzerland 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. [2021]

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

High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. [2020]

9. United States 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. [2023]