Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
All Genders
ID06788275

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)

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

132

Participants Needed

2

Research Sites

26 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

Researchers are studying the effects of different aerobic exercise methods on endothelial function in patients with ischaemic heart disease (IHD). The study focuses on comparing long high-intensity interval training (HIIT), short HIIT, and moderate-intensity training (MIT) to evaluate their impact on blood vessel health, cardiorespiratory fitness, brain-derived neurotrophic factor (BDNF) levels, and parasympathetic nervous system activity. This multicenter randomized trial will include 132 men and women aged 45 to 75 years, diagnosed with IHD between three and twelve months prior, and without exercise limitations. Participants will be randomly assigned to one of three groups: moderate-intensity continuous cycling (MIT), short HIIT involving 1-minute intense intervals, or long HIIT with 4-minute intense intervals. Each participant will exercise on a cycle ergometer three times per week for 12 weeks, totaling 36 supervised sessions. Exercise intensity will be individually set based on cardiopulmonary exercise testing and adjusted midway through the program. Participants are asked to avoid additional exercise training but may engage in light physical activity as recommended. Assessments will occur before the intervention, at 6 weeks, and after 12 weeks, measuring physiological and psychological variables. Researchers will evaluate changes in endothelial function, aerobic efficiency, cardiopulmonary performance, BDNF levels, pulmonary function, heart rate variability, echocardiographic markers, body composition, and cognitive abilities. The study includes careful monitoring and comparison of these health indicators to understand how exercise type influences outcomes in IHD patients.

CONDITIONS

Brief 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 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants undergo supervised aerobic exercise training on a cycle ergometer three times a week for 12 weeks. They are assigned to one of three exercise methods: moderate-intensity continuous training, short high-intensity interval training, or long high-intensity interval training. Participants are asked to avoid additional structured exercise but may perform light physical activity as recommended.

36 supervised exercise sessions (in-person) over 12 weeks

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

A

Agustin Manresa Rocamora, PhD

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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Published Research Related To This Trial

Effects of high-intensity interval training on vascular function in patients with cardiovascular disease: a systematic review and meta-analysis.

Laura Fuertes-Kenneally, Carles Blasco-Peris, Antonio Casanova-Lizón...

https://pubmed.ncbi.nlm.nih.gov/37576344