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Coronary Artery DiseaseBREATHENCT05632614

Blood Flow Reserve: Effects After Training With Heavy Inspiratory Exercises

A study testing High-intensity IMST and Low-intensity IMST in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
High-intensity IMST and Low-intensity IMST
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
8 May 2023to 7 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age;
  • Patients referred to PET at the University of Ottawa Heart Institute;
  • able to perform a respiratory exercise testing; and,
  • Patients with clinical stability, including no change in medications for the past one month.

Who cannot join

  • unstable angina or established diagnosis of severe valvular heart disease, hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease;
  • unable to follow training/breathing instructions;
  • unable to return for follow-up visit;
  • presence of any major non-cardiac problem that would adversely affect survival during the study in the opinion of the investigator; or,
  • unable to provide informed consent.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 1J7

Other trials in Canada

About this study

Official title: The Efficacy of Inspiratory Muscle Strength Training on Coronary Blood Flow in Patients With Coronary Artery Disease

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:

Read more
  • 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.

Read the 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.

Being tested
High-intensity IMST, Low-intensity IMST
Keywords
inspiratory muscle strength training, coronary artery disease, positron emission tomography, myocardial blood flow
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity IMSTDevice

    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.

  • Low-intensity IMSTDevice

    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 during week 1, 17% PIMAX during week 2, and 19% PIMAX during weeks 3 to 6.

Study groups in NCT05632614
Study groupRoleWhat they receive
High-intensity IMSTActive comparatorParticipants who will be trained with high-intensity IMST
Receives: Device: High-intensity IMST
Low-intensity IMSTSham comparatorParticipants who will be trained with low-intensity IMST
Receives: Device: Low-intensity IMST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global myocardial flow reserve

    Change in global myocardial flow reserve on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  2. Global stress myocardial blood flow

    Change in global stress myocardial blood flow on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

Secondary outcomes (15)
  1. Global rest myocardial blood flow

    Change in global rest myocardial blood flow on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  2. Maximum myocardial flow reserve

    Change in maximum myocardial flow reserve on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  3. Maximum myocardial blood flow at rest and stress

    Change in maximum myocardial blood flow at rest and stress on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  4. Global coronary vascular resistance at stress and rest

    Change in global coronary vascular resistance at stress and rest on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  5. Maximum coronary vascular resistance at stress and rest

    Change in maximum coronary vascular resistance at stress and rest on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  6. Mean segmental (17-segment model) myocardial flow reserve

    Change in mean segmental (17-segment model) myocardial flow reserve on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  7. Mean segmental (17-segment model) myocardial blood flow at stress and rest

    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

    Measured: Through study completion, an average of 8 weeks

  8. Maximal segmental (17-segment model) myocardial blood flow at stress and rest

    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

    Measured: Through study completion, an average of 8 weeks

  9. Summed stress score, summed rest score, and summed difference score

    Change in summed stress score, summed rest score, and summed difference score on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  10. % left ventricular ischemia

    Change in % left ventricular ischemia on positron emission tomography coronary perfusion imaging before and after IMST

    Measured: Through study completion, an average of 8 weeks

  11. General quality of life

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

    Measured: Through study completion, an average of 8 weeks

  12. Angina symptom

    Change in angina symptom assessed using the Seattle angina Questionnaire

    Measured: Through study completion, an average of 8 weeks

  13. Adherence of IMST program

    The proportion of participants adhering to prescribed IMST sessions

    Measured: Through study completion, an average of 8 weeks

  14. Respiratory Muscle Strength

    Respiratory Muscle Strength assessed by % change in maximal inspiratory pressure

    Measured: Through study completion, an average of 8 weeks

  15. Resting blood pressure

    Resting blood pressure measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.

    Measured: Through study completion, an average of 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start8 May 2023
  3. Primary completion7 Aug 2025
  4. Study completion7 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05632614
Sponsor's protocol ID
20220463-01H
Acronym
BREATHE
Status last verified
Dec 2025
First submitted
12 Oct 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • World Health Organization. Global health estimates 2020: Global cause of death, 2000-2016. World Health Organization, Geneva December 2020.

  • Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.

    PubMed 22818936
  • Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Sep 10;74(10):1376-1414. doi: 10.1016/j.jacc.2019.03.009. Epub 2019 Mar 17.

    PubMed 30894319
  • Warburton DE, Katzmarzyk PT, Rhodes RE, Shephard RJ. Evidence-informed physical activity guidelines for Canadian adults. Can J Public Health. 2007;98 Suppl 2:S16-68.

    PubMed 18213940
  • Kelly S, Martin S, Kuhn I, Cowan A, Brayne C, Lafortune L. Barriers and Facilitators to the Uptake and Maintenance of Healthy Behaviours by People at Mid-Life: A Rapid Systematic Review. PLoS One. 2016 Jan 27;11(1):e0145074. doi: 10.1371/journal.pone.0145074. eCollection 2016.

    PubMed 26815199
  • Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.

    PubMed 18436118
  • Cipriano GF, Cipriano G Jr, Santos FV, Guntzel Chiappa AM, Pires L, Cahalin LP, Chiappa GR. Current insights of inspiratory muscle training on the cardiovascular system: a systematic review with meta-analysis. Integr Blood Press Control. 2019 May 20;12:1-11. doi: 10.2147/IBPC.S159386. eCollection 2019.

    PubMed 31190975
  • Craighead DH, Heinbockel TC, Freeberg KA, Rossman MJ, Jackman RA, Jankowski LR, Hamilton MN, Ziemba BP, Reisz JA, D'Alessandro A, Brewster LM, DeSouza CA, You Z, Chonchol M, Bailey EF, Seals DR. Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. J Am Heart Assoc. 2021 Jul 6;10(13):e020980. doi: 10.1161/JAHA.121.020980. Epub 2021 Jun 29.

    PubMed 34184544
  • Craighead DH, Heinbockel TC, Hamilton MN, Bailey EF, MacDonald MJ, Gibala MJ, Seals DR. Time-efficient physical training for enhancing cardiovascular function in midlife and older adults: promise and current research gaps. J Appl Physiol (1985). 2019 Nov 1;127(5):1427-1440. doi: 10.1152/japplphysiol.00381.2019. Epub 2019 Sep 26.

    PubMed 31556835
  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

    PubMed 18183564

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity IMST and Low-intensity IMST in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global myocardial flow reserve (time frame: Through study completion, an average of 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05632614, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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