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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 8 weeks

Awards & highlights

BREATHE Trial 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.Check my eligibility

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.See study design

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.

BREATHE Trial 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.

BREATHE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 8 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Global myocardial flow reserve

Global stress myocardial blood flow

Secondary outcome measures

% left ventricular ischemia

Adherence of IMST program

Angina symptom

+12 more

BREATHE 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor

188 Previous Clinical Trials

92,396 Total Patients Enrolled

49 Trials studying Coronary Artery Disease

37,856 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for volunteers in this trial?

"As per the information on clinicaltrials.gov, this research is still actively recruiting participants – with its initial posting having been made on May 8th 2023 and most recently updated July 31st of that same year."

Answered by AI

What is the enrollment tally for this trial?

"Affirmative. According to the information available on clinicaltrials.gov, this trial is actively recruiting participants; it was first posted on May 8th 2023 and updated most recently on July 31st of that same year. 40 individuals are required for enrolment at one medical facility."

Answered by AI

What are the anticipated results of this experimental research?

"This trial, which will be observed over an 8-week period, has the primary goal of assessing Global stress myocardial blood flow. Secondary objectives include evaluating % left ventricular ischemia as denoted by Change in global rest myocardial blood flow on positron emission tomography coronary perfusion imaging before and after IMST, delving into general Quality of Life using EQ5D-5L results to measure change, and gauging Global rest myocardial blood flow prior to and following IMST treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blood Flow Reserve: Effects After Training With Heavy Inspiratory Exercises

2023. "Blood Flow Reserve: Effects After Training With Heavy Inspiratory Exercises". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05632614.

All > Coronary Artery Disease