Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease

Launched by INSTITUTO DE INVESTIGACIÓN SANITARIA Y BIOMÉDICA DE ALICANTE · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different types of aerobic exercise can improve heart health in patients with ischaemic heart disease (IHD), which includes conditions like angina and those who have had a heart attack. The researchers want to find out if high-intensity interval training (HIIT), moderate-intensity training (MIT), or longer HIIT sessions have the best effect on a specific measure of heart health called endothelial function. This function is important because it helps blood vessels work properly. The trial will involve 132 men and women aged 45 to 75 who have been diagnosed with IHD in the past year and are physically inactive.

Participants in the study will exercise three times a week for 12 weeks and will be assessed at the beginning, midway through, and at the end of the program. During these assessments, the researchers will look at various health factors related to heart function and overall well-being. To join the study, participants should be able to read and speak Spanish, have no significant physical limitations, and not be involved in other exercise programs. It’s important to know that this study will take place in hospitals in Elche and Alicante, and while participants will know which exercise group they are in, the researchers assessing the outcomes will not.

Gender

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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.