NCT05632614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

May 8, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2025

Completed
Last Updated

May 5, 2026

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

October 12, 2022

Last Update Submit

April 28, 2026

Conditions

Coronary Artery Disease

Keywords

inspiratory muscle strength trainingcoronary artery diseasepositron emission tomographymyocardial blood flow

Outcome Measures

Primary Outcomes (2)

  • Global myocardial flow reserve

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

    Through study completion, an average of 8 weeks

  • Global stress myocardial blood flow

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

    Through study completion, an average of 8 weeks

Secondary Outcomes (15)

  • Global rest myocardial blood flow

    Through study completion, an average of 8 weeks

  • Maximum myocardial flow reserve

    Through study completion, an average of 8 weeks

  • Maximum myocardial blood flow at rest and stress

    Through study completion, an average of 8 weeks

  • Global coronary vascular resistance at stress and rest

    Through study completion, an average of 8 weeks

  • Maximum coronary vascular resistance at stress and rest

    Through study completion, an average of 8 weeks

  • +10 more secondary outcomes

Study Arms (2)

High-intensity IMST

ACTIVE COMPARATOR

Participants who will be trained with high-intensity IMST

Device: High-intensity IMST

Low-intensity IMST

SHAM COMPARATOR

Participants who will be trained with low-intensity IMST

Device: Low-intensity IMST

Interventions

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.

High-intensity IMST
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.

Low-intensity IMST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 1J7, Canada

Location

Related Publications (10)

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

    BACKGROUND

  • 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.

    PMID: 22818936BACKGROUND

  • 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.

    PMID: 30894319BACKGROUND

  • 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.

    PMID: 18213940BACKGROUND

  • 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.

    PMID: 26815199BACKGROUND

  • 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.

    PMID: 18436118BACKGROUND

  • 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.

    PMID: 31190975BACKGROUND

  • 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.

    PMID: 34184544BACKGROUND

  • 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.

    PMID: 31556835BACKGROUND

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

    PMID: 18183564BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Benjamin Chow, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

November 30, 2022

Study Start

May 8, 2023

Primary Completion

August 7, 2025

Study Completion

August 7, 2025

Last Updated

May 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)