Blood Flow Reserve: Effects After Training With Heavy Inspiratory Exercises (BREATHE)

University of Ottawa Heart Institute

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Treatments: Device: High-intensity IMST; Device: Low-intensity IMST

Study type: Interventional

Funder types: Other

Identifiers

NCT05632614

20220463-01H

Details and patient eligibility

About

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.

Full description

Coronary artery disease (CAD) is a leading cause of morbidity and mortality. With the aging population, increasing number of patients with CAD has frailty and immobility. The health benefits of traditional aerobic exercise have been well-established; however, alternative exercise programs, such as inspiratory muscle training (IMST), may provide greater merits. IMST is a form of exercise that engages the diaphragm and accessory respiratory muscles to repeatedly inhale against resistance, which can be achieved in less time and widely applicable even for immobile or frail patients compared to conventional aerobic exercise. Since barriers to conventional exercise training include immobility, lack of time, and access to facilities, IMST may be a beneficial exercise form that can overcome those factors. A previous study has shown that high-intensity IMT can lower blood pressure and improved vascular endothelial function. Improvements in endothelial function of coronary arteries could improve coronary blood flow, leading to the improvement of anginal symptoms as well as quality of life. IMST might offer a widely applicable, feasible, time-efficient form of training for CAD patients. Our study will examine the preliminary efficacy of IMST on coronary blood flow in patients with CAD.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years of age;
2. Patients referred to PET at the University of Ottawa Heart Institute;
3. able to perform a respiratory exercise testing; and,
4. Patients with clinical stability, including no change in medications for the past one month.

Exclusion criteria

1. unstable angina or established diagnosis of severe valvular heart disease, hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease;
2. unable to follow training/breathing instructions;
3. unable to return for follow-up visit;
4. presence of any major non-cardiac problem that would adversely affect survival during the study in the opinion of the investigator; or,
5. unable to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

High-intensity IMST

Active Comparator group

Description:

Participants who will be trained with high-intensity IMST

Treatment:

Device: High-intensity IMST

Low-intensity IMST

Sham Comparator group

Description:

Participants who will be trained with low-intensity IMST

Treatment:

Device: Low-intensity IMST