Domain-specific Aerobic Exercise Training in Coronary Artery Disease

NCT06143332 | Recruiting

• 1 other identifier: 123930
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise training in cardiac rehabilitation (rehab) is a key part of managing a patient with heart disease. It has been shown that cardiac patients who increase their aerobic ("cardio") fitness by exercise training live longer, have better quality of life, and stay out of hospitals more than patients who do not improve their aerobic fitness. The more a patient improves their aerobic fitness the greater the benefit. But it has been shown that more than half of patients do not improve their aerobic fitness even after participating in cardiac rehab. This may be related to how hard patients are asked to train (their training "intensity"). The way intensity is chosen in current programs is commonly based on a "one-size fits all" method that may not consider that different patients have different abilities. There are more personalized methods to determine training intensity that exist, but these have never been used in cardiac rehab. One method divides intensity into three zones (zone 1 = moderate intensity; zone 2 = heavy intensity; zone 3 = very high intensity) that are based on when an individuals' biological responses to exercise change. The purpose of this study is to see if this approach gives better results in terms of changes in aerobic fitness and if training in the different zones makes a difference. Three groups of patients will be asked to train for 3 months in one of the three intensity zones. Aerobic fitness before and after exercise training will be compared to see which intensity zone results in the largest change.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake

  Post-training peak oxygen uptake achieved during a symptom-limited incremental exercise test to task failure

  baseline (week 0) and week 14

Secondary Outcomes (3)

• Positive responders

  week 14

• Gas exchange threshold

  baseline (week 0) and week 14

• Respiratory compensation point

  baseline (week 0) and week 14

Other Outcomes (6)

• Cardiac output

  baseline (week 0) and week 14

• Stroke volume

  baseline (week 0) and week 14

• Arterio-venous oxygen difference

  baseline (week 0) and week 14

Study Arms (3)

Moderate-intensity continuous training

EXPERIMENTAL

\~50 min of constant-power output cycling, 3 x per week at 85% of gas exchange threshold

Other: Aerobic exercise training

Heavy-intensity continuous training

EXPERIMENTAL

30 min of constant-power output cycling, 3 x per week at 70% of the difference between gas exchange threshold and respiratory compensation point

Other: Aerobic exercise training

High (severe)-intensity interval training

EXPERIMENTAL

intervals; 4 x 4 min on - 3 min off at 115% of respiratory compensation point (work) and 50-70% gas exchange threshold (recovery)

Other: Aerobic exercise training

Interventions

Aerobic exercise training OTHER

Aerobic exercise training on a cycle ergometer

Heavy-intensity continuous training; High (severe)-intensity interval training; Moderate-intensity continuous training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CAD who do not have any identified left ventricular dysfunction (i.e., left ventricular ejection fraction \[LVEF\] \<50%) and who: were discharged from the hospital following admission for acute coronary syndrome (i.e., ST-elevation or non ST-elevation myocardial infarction, addressed with PCI or CABG, as documented by their attending physician; referred to St. Joseph's CRSP Program; completed a CPET at the St. Joseph's CRSP Program (as routine screening for cardiac rehabilitation) and have been cleared to exercise in a structured format (i.e., do not exhibit any contraindications to maximal exercise); without: respiratory or musculoskeletal issues that would prohibit them from cycling exercise.

You may not qualify if:

• Those who have: diagnosed heart failure, severe aortic stenosis, congenital coronary abnormality, 2-3° atrioventricular block, major arrhythmias such as atrial fibrillation (including paroxysmal), or are scheduled to undergo PCI or CABG surgery within 2 months following hospital discharge; are using insulin for diabetes; diagnosed with respiratory disease; or musculoskeletal issues that prohibit cycling exercise; and/or are unable to provide informed consent..

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

The University of Western Ontario

London, Ontario, N6A3K7, Canada

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Daniel A Keir, PhD

CONTACT

519-661-2111; dkeir@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 22, 2023
• Study Start: November 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)