Clinical trial NCT05632614: Blood Flow Reserve: Effects After Training With Heavy Inspiratory Exercises
Official title: The Efficacy of Inspiratory Muscle Strength Training on Coronary Blood Flow in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: inspiratory muscle strength training
coronary artery disease
positron emission tomography
myocardial blood flow
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Global myocardial flow reserve
timeFrame: Through study completion, an average of 8 weeks
measure: Global stress myocardial blood flow
timeFrame: Through study completion, an average of 8 weeks
Secondary outcomes:
measure: Global rest myocardial blood flow
timeFrame: Through study completion, an average of 8 weeks
measure: Maximum myocardial flow reserve
timeFrame: Through study completion, an average of 8 weeks
measure: Maximum myocardial blood flow at rest and stress
timeFrame: Through study completion, an average of 8 weeks
measure: Global coronary vascular resistance at stress and rest
timeFrame: Through study completion, an average of 8 weeks
measure: Maximum coronary vascular resistance at stress and rest
timeFrame: Through study completion, an average of 8 weeks
measure: Mean segmental (17-segment model) myocardial flow reserve
timeFrame: Through study completion, an average of 8 weeks
measure: Mean segmental (17-segment model) myocardial blood flow at stress and rest
timeFrame: Through study completion, an average of 8 weeks
measure: Maximal segmental (17-segment model) myocardial blood flow at stress and rest
timeFrame: Through study completion, an average of 8 weeks
measure: Summed stress score, summed rest score, and summed difference score
timeFrame: Through study completion, an average of 8 weeks
measure: % left ventricular ischemia
timeFrame: Through study completion, an average of 8 weeks
measure: General quality of life
timeFrame: Through study completion, an average of 8 weeks
measure: Angina symptom
timeFrame: Through study completion, an average of 8 weeks
measure: Adherence of IMST program
timeFrame: Through study completion, an average of 8 weeks
measure: Respiratory Muscle Strength
timeFrame: Through study completion, an average of 8 weeks
measure: Resting blood pressure
timeFrame: Through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Benjamin Chow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: World Health Organization. Global health estimates 2020: Global cause of death, 2000-2016. World Health Organization, Geneva December 2020.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.