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

Sponsor
Ottawa Heart Institute Research Corporation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05632614
Collaborator
(none)
40
2
12.9

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
  • Device: High-intensity IMST
  • Device: Low-intensity IMST
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. % 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

  11. General quality of life [Through study completion, an average of 8 weeks]

    Change in general Quality of life assessed using the EQ5D-5L

  12. Angina symptom [Through study completion, an average of 8 weeks]

    Change in angina symptom assessed using the Seattle angina Questionnaire

  13. Adherence of IMST program [Through study completion, an average of 8 weeks]

    The proportion of participants adhering to prescribed IMST sessions

  14. Respiratory Muscle Strength [Through study completion, an average of 8 weeks]

    Respiratory Muscle Strength assessed by % change in maximal inspiratory pressure

  15. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.
Responsible Party:
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT05632614
Other Study ID Numbers:
  • 20220463-01H
First Posted:
Nov 30, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2022