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

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ClinicalTrials.gov Identifier: NCT05632614
Recruitment Status : Recruiting
First Posted : November 30, 2022
Last Update Posted : August 3, 2023
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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
Coronary Artery Disease Device: High-intensity IMST Device: Low-intensity IMST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Inspiratory Muscle Strength Training on Coronary Blood Flow in Patients With Coronary Artery Disease
Actual Study Start Date : May 8, 2023
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. % 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

  11. 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

  12. Angina symptom [ Time Frame: Through study completion, an average of 8 weeks ]
    Change in angina symptom assessed using the Seattle angina Questionnaire

  13. Adherence of IMST program [ Time Frame: Through study completion, an average of 8 weeks ]
    The proportion of participants adhering to prescribed IMST sessions

  14. Respiratory Muscle Strength [ Time Frame: Through study completion, an average of 8 weeks ]
    Respiratory Muscle Strength assessed by % change in maximal inspiratory pressure

  15. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05632614


Contacts
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Contact: Benjamin Chow, MD 613-696-7286 BChow@ottawaheart.ca
Contact: Yoshito Kadoya, MD, PhD 613-696-7286 YKadoya@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 1J7
Contact: Yoshito Kadoya, MD, PhD    6136967068    YKadoya@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Benjamin Chow, MD Ottawa Heart Institute Research Corporation
Publications:
World Health Organization. Global health estimates 2020: Global cause of death, 2000-2016. World Health Organization, Geneva December 2020.

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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05632614    
Other Study ID Numbers: 20220463-01H
First Posted: November 30, 2022    Key Record Dates
Last Update Posted: August 3, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Heart Institute Research Corporation:
inspiratory muscle strength training
coronary artery disease
positron emission tomography
myocardial blood flow
Additional relevant MeSH terms:
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Respiratory Aspiration
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes