Effects of aerobic exercise on heart function in patients with heart disease

Effect of Different Aerobic Exercise Methods in Cardiac Rehabilitation on Endothelial Function in Patients With Ischaemic Heart Disease and Study of the Associated Physiological Mechanisms (ENDO-R)

This study tests whether different types of aerobic exercise can improve heart function in patients with heart disease who have recently had treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: Instituto de Investigación Sanitaria y Biomédica de Alicante (network)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Alicante, Alicante and 1 other locations)
• Trial ID: NCT06788275 on ClinicalTrials.gov

What this trial studies

This study investigates how different types of aerobic exercise, specifically long and short high-intensity interval training (HIIT) and moderate-intensity training (MIT), affect endothelial function in patients with ischemic heart disease. It aims to determine which exercise method is most effective in improving flow-mediated dilation (FMD) and other health indicators in patients who have recently undergone treatments for heart conditions. Participants will engage in a structured exercise program over a set period, with evaluations to assess their cardiovascular health and fitness levels.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 45 to 75 with a recent diagnosis of acute myocardial infarction or unstable/stable angina who are physically inactive.

Not a fit: Patients with significant physical limitations or those who are already engaged in regular structured exercise programs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved exercise recommendations for patients with ischemic heart disease, enhancing their cardiovascular health and overall quality of life.

How similar studies have performed: Previous studies have shown positive effects of aerobic exercise on endothelial function in heart disease patients, but this specific comparison of exercise types is novel.

Eligibility criteria

Inclusion Criteria:

* Men and women aged between 45 and 75 years.
* Diagnosed with acute myocardial infarction, unstable or stable angina.
* Treated with percutaneous coronary intervention, coronary artery bypass grafting, or conservative treatment.
* Event or intervention within 3 to 12 months prior to participation in the study.
* Fluency in speaking and reading Spanish.
* Residing in Elche or surrounding areas and able to attend evaluations and the exercise programme (not planning to be absent for more than one week during the programme).
* Functional Class I-II according to the New York Heart Association (NYHA) classification.
* No physical limitations for exercise.
* Stable optimal medical treatment.
* Physically inactive, defined as 1) not meeting the World Health Organization recommendations for both aerobic and strength exercise, and 2) not participating in a structured exercise programme at least 3 days per week for more than 3 months. Both conditions must be met for inclusion. Note: Casual walking is not considered grounds for exclusion.

Exclusion Criteria:

* Use of walking assistive devices.
* Treatment with chemotherapy for any type of cancer in the past 2 years.
* Hospitalisation in an intensive care unit in the past 6 months for reasons other than the ischaemic event.
* Acute myocardial infarction group IV Killip-Kimball.
* Obesity grade III (≥40.0 kg/m²).
* Medical contraindication for inclusion in an exercise programme.
* Diabetes with uncontrolled blood glucose levels.
* Poorly controlled hypertension: resting blood pressure \> 180/110 mmHg.
* Chest pain with exertion or ST-segment changes suggestive of residual ischemia during ergometry. Residual ischemia.
* Severely reduced functional capacity on initial ergometry (\<5 metabolic equivalent of task).
* Left ventricular ejection fraction less than 50%.
* Severe stenosis of the left main coronary artery (\>50% significant disease).
* Severe aortic stenosis, left ventricular outflow tract obstruction (e.g., obstructive hypertrophic cardiomyopathy) or aortic dissection.
* Severe valvulopathy.
* Acute pulmonary embolism or deep vein thrombosis.
* Severe pulmonary hypertension.
* Acute heart failure.
* Acute endocarditis, myocarditis, or pericarditis.
* Acute or chronic renal insufficiency (estimated glomerular filtration rate \<30 ml/min).
* Pulmonary fibrosis or interstitial disease (severe respiratory insufficiency or confirmed chronic obstructive pulmonary disease).
* Uncontrolled cardiac arrhythmias/hemodynamically unstable.
* Permanent or persistent/paroxysmal atrial fibrillation with episodes in the past 6 months.
* High-grade cardiac block.
* Presence of implantable devices: cardiac resynchronization therapy pacemaker, implantable cardioverter defibrillators, or pacemaker.
* Presence of ischaemic symptoms during the incremental exercise test performed before the intervention.
* Severe autonomic or peripheral neuropathy.
* Use of nitrates in pharmacological treatment.
* Any planned surgical or medical intervention during the study period.
* Plans to participate in or current participation in other studies that may interfere with this study.
* Current pregnancy or intention to become pregnant during the study period.

Where this trial is running

Alicante, Alicante and 1 other locations

• Instituto de Investigación Sanitaria y Biomédica de Alicante — Alicante, Alicante, Spain (RECRUITING)
• Centro de Investigación del deporte — Elche, Alicante, Spain (RECRUITING)

Study contacts

• Study coordinator: Jose Manuel Sarabia, PhD

Conditions: Percutaneous Coronary Intervention, Acute Myocardial Infarction, Angina, Unstable Angina Pectoris, Cardiorespiratory Fitness, Ischaemic Heart Diseases, Aerobic exercise, High-intensity interval training