IMST for Coronary Heart Disease
(BREATHE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byBenjamin Chow, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ottawa Heart Institute Research Corporation
Disqualifiers: Unstable angina, Severe valvular heart disease, COPD, others
No Placebo Group
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.
12345Is 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.
15678How 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.
12349Eligibility 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.
+1 more
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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: High-intensity IMSTActive Control1 Intervention
Participants who will be trained with high-intensity IMST
Group II: Low-intensity IMSTPlacebo Group1 Intervention
Participants who will be trained with low-intensity IMST
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Ottawa Heart InstituteOttawa, Canada
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Who Is Running the Clinical Trial?
Ottawa Heart Institute Research CorporationLead Sponsor
References
Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]Inspiratory muscle strength training (IMST) has been traditionally recommended for patients with chronic obstructive pulmonary disease (COPD) to improve respiratory strength. Respiratory strength is reduced as age increases. However, few studies have focused on the effects of IMST on older adults without COPD.
Inspiratory muscle strength training in infants with congenital heart disease and prolonged mechanical ventilation: a case report. [2021]Inspiratory muscle strength training (IMST) has been shown to improve maximal pressures and facilitate ventilator weaning in adults with prolonged mechanical ventilation (MV). The purposes of this case report are: (1) to describe the rationale for IMST in infants with MV dependence and (2) to summarize the device modifications used to administer training.
Effects of High-Intensity Inspiratory Muscle Training Associated with Aerobic Exercise in Patients Undergoing CABG: Randomized Clinical Trial. [2019]Evaluate the interaction between high-intensity inspiratory muscle training (IMT) and aerobic exercise on physical capacity, respiratory muscle strength, peripheral muscle strength, and quality of life of patients who underwent coronary artery bypass grafting (CABG).
Inspiratory muscle training in patients with heart failure: a systematic review. [2021]The purpose of this review was to assess the quality of evidence on inspiratory muscle training (IMT) in patients with heart failure and to provide an overview on subject selection, training protocols, and outcome achieved with IMT.
Inspiratory Muscle Training in Patients With Heart Failure: What Is New? Systematic Review and Meta-Analysis. [2021]The benefits of inspiratory muscle training (IMT) have already been demonstrated in patients with heart failure (HF), but the best mode of training and which patients benefit from this intervention are not clear. The purpose of this study was to review the effects of IMT on respiratory muscle strength, functional capacity, pulmonary function, quality of life, and dyspnea in patients with HF; IMT isolated or combined with another intervention (combined IMT), the presence of inspiratory muscle weakness, training load, and intervention time were considered.
Moderate- and High-Intensity Inspiratory Muscle Training Equally Improves Inspiratory Muscle Strength and Endurance-A Double-Blind Randomized Controlled Trial. [2022]Inspiratory muscle training (IMT) produced outstanding results in the physical performance of active subjects; however, little is known about the best training intensity for this population. The objective was to investigate the impact of an IMT of high intensity, using the critical inspiratory pressure (CIP), on inspiratory muscle strength (IMS), inspiratory muscle endurance (IME), peak power, and oxygen uptake of recreational cyclists; and to compare these results with moderate-intensity IMT (60% of maximal inspiratory pressure [MIP]).
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]Background: Uncommonly high rates of pneumonia in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI) have been observed during recent years. Inspiratory muscle training (IMT) could reduce pneumonia in patients undergoing coronary artery bypass grafting and other cardiac surgeries. The relationship between IMT and AMI is unknown. Here, we describe the feasibility and potential benefit of IMT in patients at high risk for pneumonia with AMI who have undergone primary PCI. Methods: Our study is a prospective, randomized, controlled, single-center clinical trial. A total of 60 participants will be randomized into an IMT group and control group with 30 participants in each group. Participants in the IMT group will undergo training for 15 min per session, twice a day, from 12 to 24 h after primary PCI, until 30 days post-randomization; usual care will be provided for the control group. The primary endpoint is the change in inspiratory muscle strength, the secondary endpoint included feasibility, pneumonia, major adverse cardiovascular events, length of stay, pulmonary function tests measure, and quality of life. Discussion: Our study is designed to evaluate the feasibility of IMT and its effectiveness in improving inspiratory muscle strength in participants with AMI who have undergone primary PCI. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04491760.
High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. [2020]The purpose of this study was to evaluate the effectiveness, feasibility, and safety of a 4-week high-intensity inspiratory muscle training (hi-IMT) in patients with chronic heart failure (CHF).
The efficacy of inspiratory muscle training in patients with coronary artery disease: Protocol for a systematic review and meta-analysis. [2023]Inspiratory muscle training (IMT) has been recognized as an effective form of training in patients with cardiovascular disease and heart failure. However, little is known about the efficacy of IMT in the treatment of patients with coronary artery disease (CAD). The aim of this systematic review will be to evaluate randomized controlled studies to understand the effect of IMT on CAD patients.