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Behavioural Intervention

IMST for Coronary Heart Disease (BREATHE Trial)

N/A
Recruiting
Led By Benjamin Chow, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Patients with clinical stability, including no change in medications for the past one month
Must not have
Unstable angina or established diagnosis of severe valvular heart disease, hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease
Unable to follow training/breathing instructions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 8 weeks

Summary

This trial aims to see if high-intensity IMST can improve coronary blood flow in patients with CAD. Participants will do 8 weeks of IMST and researchers will compare results.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed for IMST, potential risks may include discomfort or fatigue from the exercises. Since it's a breathing-focused intervention, there might also be an increased risk of pulmonary issues if not performed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My medications have been the same for the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart or lung conditions.
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I cannot follow instructions for training or breathing exercises.
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I cannot come back for follow-up visits.
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I am unable to understand and agree to the study's details on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Global myocardial flow reserve
Global stress myocardial blood flow
Secondary study objectives
% left ventricular ischemia
Adherence of IMST program
Angina symptom
+12 more

Trial Design

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 Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
195 Previous Clinical Trials
93,460 Total Patients Enrolled
50 Trials studying Coronary Artery Disease
37,821 Patients Enrolled for Coronary Artery Disease
Benjamin Chow, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
3 Previous Clinical Trials
308 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
168 Patients Enrolled for Coronary Artery Disease

Media Library

High-intensity IMST (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05632614 — N/A
Coronary Artery Disease Research Study Groups: High-intensity IMST, Low-intensity IMST
Coronary Artery Disease Clinical Trial 2023: High-intensity IMST Highlights & Side Effects. Trial Name: NCT05632614 — N/A
High-intensity IMST (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05632614 — N/A
~2 spots leftby Dec 2024
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