Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
All Genders
NCT06788275

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

Led by Instituto de Investigación Sanitaria y Biomédica de Alicante · Updated on 2026-02-27

132

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

Sponsors

I

Instituto de Investigación Sanitaria y Biomédica de Alicante

Lead Sponsor

U

Universidad Miguel Hernandez de Elche

Collaborating Sponsor

AI-Summary

What this Trial Is About

Endothelial dysfunction is one of the aetiological factors in ischaemic heart disease (IHD). Aerobic exercise is effective in improving endothelial function, as measured by flow-mediated dilation (FMD), in patients with IHD. Within the aerobic exercise methods, there is evidence showing that high-intensity interval training (HIIT) increases FMD to a greater extent than moderate-intensity training (MIT) in these patients. Notably, in a recent review, our research group found that only studies performing long bouts of HIIT (long HIIT: higher than 1 min) found a greater effect on FMD, while no differences were found in those studies using short bouts of HIIT (short HIIT: ≤ 1 min) and MIT. However, no experimental studies comparing the effect of long HIIT, short HIIT, and MIT on endothelial function, as well as other predictors of mortality, such as cardiorespiratory fitness, brain-derived neurotrophic factor (BDNF) levels or parasympathetic branch activity, have been performed. Therefore, the main objective of this project will be to compare the effect of the three aerobic exercise methods on endothelial function, as measured by FMD, in patients with IHD. Complementarily, the effect of aerobic exercise, depending on the exercise method, on different mortality predictors will be compared. For this purpose, a multicentre randomised study will be carried out (2 hospitals in Elche and one in Alicante). Assessors will be blinded to the patients allocation. Participants will be aware about their allocation in the experimental groups due to the nature of the study. A total of 132 men and women with IHD (66 per sex), diagnosed between three and 12 months before the start of the intervention, aged between 45 and 75 years, and without limitations for the practice of exercise training, will be recruited. All patients will train 3 days a week for 12 weeks. Participants will be assessed before the intervention (i.e., pre), at 6 weeks of training (i.e., mid) and after the intervention (i.e., post). Physiological and psychological variables will be registered in the assessment periods. Training intensity will be individually prescribed based on the cardiopulmonary exercise test (CPET). Intensity exercise will be adapted after the first part of the intervention. Analysis of covariance will be used to compare the values of the three groups after the intervention for the continuous variables, including the pre-intervention value as a covariate, while a logistic regression model will be used for the categorical variables.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 occurred 3 to 12 months before study participation
  • Fluent in speaking and reading Spanish
  • Live in Elche or surrounding areas and able to attend evaluations and exercise program without missing more than one week
  • Functional Class I-II according to the New York Heart Association classification
  • No physical limitations for exercise
  • Stable optimal medical treatment
  • Physically inactive, not meeting WHO recommendations for aerobic and strength exercise and not in a structured exercise program at least 3 days per week for over 3 months; casual walking does not exclude
Not Eligible

You will not qualify if you...

  • Use of walking assistive devices
  • Chemotherapy treatment for any cancer in the past 2 years
  • Hospitalization in intensive care for reasons other than ischemic event in past 6 months
  • Acute myocardial infarction group IV Killip-Kimball
  • Obesity grade III (BMI ≥ 40.0 kg/m²)
  • Medical contraindication for exercise program
  • Diabetes with uncontrolled blood glucose
  • Poorly controlled hypertension (resting blood pressure > 180/110 mmHg)
  • Chest pain or ST-segment changes indicating residual ischemia during ergometry
  • Severely reduced functional capacity on initial ergometry (<5 metabolic equivalents)
  • Left ventricular ejection fraction less than 50%
  • Severe stenosis of left main coronary artery (>50% disease)
  • Severe aortic stenosis, left ventricular outflow obstruction, 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 (glomerular filtration rate <30 ml/min)
  • Pulmonary fibrosis or interstitial disease with severe respiratory insufficiency or COPD
  • Uncontrolled cardiac arrhythmias or hemodynamic instability
  • Permanent or persistent/paroxysmal atrial fibrillation with episodes in past 6 months
  • High-grade cardiac block
  • Presence of implantable devices like resynchronization therapy pacemaker or defibrillators
  • Ischemic symptoms during incremental exercise test before intervention
  • Severe autonomic or peripheral neuropathy
  • Use of nitrates in treatment
  • Planned surgical or medical intervention during study period
  • Current or planned participation in other interfering studies
  • Current pregnancy or intention to become pregnant during study period

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Instituto de Investigación Sanitaria y Biomédica de Alicante

Alicante, Alicante, Spain, 03010

Actively Recruiting

2

Centro de Investigación del deporte

Elche, Alicante, Spain, 03202

Actively Recruiting

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Research Team

J

Jose Manuel Sarabia, PhD

CONTACT

A

Agustin Manresa Rocamora, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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