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

April 8, 2024 updated by: Ottawa Heart Institute Research Corporation

The Efficacy of Inspiratory Muscle Strength Training on Coronary Blood Flow in Patients With Coronary Artery Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 1J7
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High-intensity IMST
Participants who will be trained with high-intensity IMST
Device: High-intensity IMST
Participants will use the POWERbreathe KHP2 inspiratory muscle training device. All participants will be assigned to perform 30 inspiratory maneuvers (5 sets of 6, 1-minute rest between sets), 6 days per week, for 6 weeks. Participants will be trained at 55% PIMAX during week 1, 65% PIMAX during week 2, and 75% PIMAX during weeks 3 to 6.
Sham Comparator: Low-intensity IMST
Participants who will be trained with low-intensity IMST
Device: Low-intensity IMST
Participants will use the POWERbreathe KHP2 inspiratory muscle training device. All participants will be assigned to perform 30 inspiratory maneuvers (5 sets of 6, 1-minute rest between sets), 6 days per week, for 6 weeks. Participants will be trained at 15% PIMAX for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global myocardial flow reserve
Time Frame: Through study completion, an average of 8 weeks
Change in global myocardial flow reserve on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Global stress myocardial blood flow
Time Frame: Through study completion, an average of 8 weeks
Change in global stress myocardial blood flow on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global rest myocardial blood flow
Time Frame: Through study completion, an average of 8 weeks
Change in global rest myocardial blood flow on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Maximum myocardial flow reserve
Time Frame: Through study completion, an average of 8 weeks
Change in maximum myocardial flow reserve on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Maximum myocardial blood flow at rest and stress
Time Frame: Through study completion, an average of 8 weeks
Change in maximum myocardial blood flow at rest and stress on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Global coronary vascular resistance at stress and rest
Time Frame: Through study completion, an average of 8 weeks
Change in global coronary vascular resistance at stress and rest on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Maximum coronary vascular resistance at stress and rest
Time Frame: Through study completion, an average of 8 weeks
Change in maximum coronary vascular resistance at stress and rest on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Mean segmental (17-segment model) myocardial flow reserve
Time Frame: Through study completion, an average of 8 weeks
Change in mean segmental (17-segment model) myocardial flow reserve on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Mean segmental (17-segment model) myocardial blood flow at stress and rest
Time Frame: Through study completion, an average of 8 weeks
Change in mean segmental (17-segment model) myocardial blood flow at stress and rest on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Maximal segmental (17-segment model) myocardial blood flow at stress and rest
Time Frame: Through study completion, an average of 8 weeks
Change in maximal segmental (17-segment model) myocardial blood flow at stress and rest on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
Summed stress score, summed rest score, and summed difference score
Time Frame: Through study completion, an average of 8 weeks
Change in summed stress score, summed rest score, and summed difference score on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
% left ventricular ischemia
Time Frame: Through study completion, an average of 8 weeks
Change in % left ventricular ischemia on positron emission tomography coronary perfusion imaging before and after IMST
Through study completion, an average of 8 weeks
General quality of life
Time Frame: Through study completion, an average of 8 weeks
Change in general Quality of life assessed using the EQ5D-5L
Through study completion, an average of 8 weeks
Angina symptom
Time Frame: Through study completion, an average of 8 weeks
Change in angina symptom assessed using the Seattle angina Questionnaire
Through study completion, an average of 8 weeks
Adherence of IMST program
Time Frame: Through study completion, an average of 8 weeks
The proportion of participants adhering to prescribed IMST sessions
Through study completion, an average of 8 weeks
Respiratory Muscle Strength
Time Frame: Through study completion, an average of 8 weeks
Respiratory Muscle Strength assessed by % change in maximal inspiratory pressure
Through study completion, an average of 8 weeks
Resting blood pressure
Time Frame: Through study completion, an average of 8 weeks
Resting blood pressure measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.
Through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Benjamin Chow, MD, Ottawa Heart Institute Research Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220463-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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