Blood Flow Reserve: Effects After Training With Heavy Inspiratory Exercises

Coronary Artery Disease Clinical Trial

— BREATHE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632614
• Other study ID #: 20220463-01H
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Benjamin Chow, MD
• Phone: 613-696-7286
• Email: BChow[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Respiratory Aspiration

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. Erratum In: J Am Coll Cardiol. 2019 Sep 10;74(10):1428-1429. J Am Coll Cardiol. 2020 Feb 25;75(7):840. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Global rest myocardial blood flow	Change in global rest myocardial blood flow on positron emission tomography coronary perfusion imaging before and after IMST	Through study completion, an average of 8 weeks
Secondary	Maximum myocardial flow reserve	Change in maximum myocardial flow reserve on positron emission tomography coronary perfusion imaging before and after IMST	Through study completion, an average of 8 weeks
Secondary	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	Through study completion, an average of 8 weeks
Secondary	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	Through study completion, an average of 8 weeks
Secondary	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	Through study completion, an average of 8 weeks
Secondary	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	Through study completion, an average of 8 weeks
Secondary	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	Through study completion, an average of 8 weeks
Secondary	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	Through study completion, an average of 8 weeks
Secondary	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	Through study completion, an average of 8 weeks
Secondary	% left ventricular ischemia	Change in % left ventricular ischemia on positron emission tomography coronary perfusion imaging before and after IMST	Through study completion, an average of 8 weeks
Secondary	General quality of life	Change in general Quality of life assessed using the EQ5D-5L	Through study completion, an average of 8 weeks
Secondary	Angina symptom	Change in angina symptom assessed using the Seattle angina Questionnaire	Through study completion, an average of 8 weeks
Secondary	Adherence of IMST program	The proportion of participants adhering to prescribed IMST sessions	Through study completion, an average of 8 weeks
Secondary	Respiratory Muscle Strength	Respiratory Muscle Strength assessed by % change in maximal inspiratory pressure	Through study completion, an average of 8 weeks
Secondary	Resting blood pressure	Resting blood pressure measured in a seated position after a 5-minute rest period using an automated blood pressure monitor.	Through study completion, an average of 8 weeks