BREATHE: Blood Flow Reserve: Effects After Training With Heavy Inspiratory Exercises
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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.
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Outcome Measures
Primary Outcome Measures
- Global myocardial flow reserve [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
- Global stress myocardial blood flow [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
Secondary Outcome Measures
- Global rest myocardial blood flow [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
- Maximum myocardial flow reserve [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
- Maximum myocardial blood flow at rest and stress [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
- Global coronary vascular resistance at stress and rest [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
- Maximum coronary vascular resistance at stress and rest [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
- Mean segmental (17-segment model) myocardial flow reserve [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
- Mean segmental (17-segment model) myocardial blood flow at stress and rest [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
- Maximal segmental (17-segment model) myocardial blood flow at stress and rest [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
- Summed stress score, summed rest score, and summed difference score [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
- % left ventricular ischemia [Through study completion, an average of 8 weeks]
Change in % left ventricular ischemia on positron emission tomography coronary perfusion imaging before and after IMST
- General quality of life [Through study completion, an average of 8 weeks]
Change in general Quality of life assessed using the EQ5D-5L
- Angina symptom [Through study completion, an average of 8 weeks]
Change in angina symptom assessed using the Seattle angina Questionnaire
- Adherence of IMST program [Through study completion, an average of 8 weeks]
The proportion of participants adhering to prescribed IMST sessions
- Respiratory Muscle Strength [Through study completion, an average of 8 weeks]
Respiratory Muscle Strength assessed by % change in maximal inspiratory pressure
- Resting blood pressure [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.
Eligibility Criteria
Criteria
Inclusion criteria:
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≥18 years of age;
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Patients referred to PET at the University of Ottawa Heart Institute;
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able to perform a respiratory exercise testing; and,
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Patients with clinical stability, including no change in medications for the past one month.
Exclusion criteria:
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unstable angina or established diagnosis of severe valvular heart disease, hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease;
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unable to follow training/breathing instructions;
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unable to return for follow-up visit;
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presence of any major non-cardiac problem that would adversely affect survival during the study in the opinion of the investigator; or,
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unable to provide informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ottawa Heart Institute Research Corporation
Investigators
- Principal Investigator: Benjamin Chow, MD, Ottawa Heart Institute Research Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20220463-01H