Percutaneous Coronary Intervention (PCI)ENDO-RNCT06788275
Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease
A study testing Aerobic exercise (MIT), Aerobic exercise (Short HIIT) and Aerobic exercise (Long HIIT) in people with Percutaneous Coronary Intervention (PCI) and Acute Myocardial Infarction, run by Instituto de Investigación Sanitaria y Biomédica de Alicante at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Percutaneous Coronary Intervention (PCI), Acute Myocardial Infarction, Angina (Stable)
- What is being tested?
- Aerobic exercise (MIT), Aerobic exercise (Short HIIT) and Aerobic exercise (Long HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Nov 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Instituto de Investigación Sanitaria y Biomédica de Alicante
Alicante, Alicante, 03010
Carles Blasco, Master, 965 913 941, blasco_car@isabial.es
- Recruiting
Centro de Investigación del deporte
Elche, Alicante, 03202
José M Sarabia Marín, PhD, +34965222568, jsarabia@umh.es
About this study
Official title: 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)
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
- Percutaneous Coronary Intervention (PCI), Acute Myocardial Infarction, Angina (Stable), Unstable Angina Pectoris, Cardiorespiratory Fitness, Ischaemic Heart Diseases
- Being tested
- Aerobic exercise (MIT), Aerobic exercise (Short HIIT), Aerobic exercise (Long HIIT)
- Keywords
- Aerobic exercise, High-intensity interval training, Cardiac rehabilitation, Multicenter study, Coronary artery disease, Flow-mediated dilation, Nitroglycerin-mediated dilation, Mortality predictors
- Medical subject headings
- Angina, Stable, Angina, Unstable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise (MIT)Behavioural
Also called MIT
Patients allocated to the MIT group will train on a cycle ergometer three days a week for 12 weeks (36 sessions). They will cycle continuously between the first and second ventilatory thresholds. The duration of each exercise session will be set according to the estimated energy expenditure of the long HIIT and short HIIT groups for each training block (energy expenditure-adjusted exercise sessions). All sessions will be supervised, and patients will be asked to avoid additional exercise. They will be allowed to perform extra physical activity (e.g., light walking) according to medical recommendations.
Aerobic exercise (Short HIIT)Behavioural
Also called Short HIIT
Patients allocated to the Short HIIT group will train on a cycle ergometer three days a week for 12 weeks (36 sessions). They will perform from two to four 4-repetition sets of 1-min above the second ventilatory threshold. Patients will perform 1- and 3-min active recovery periods below the first ventilatory threshold between repetitions and sets, respectively. The total time spent at high intensity will range from eight to 16 min. All sessions will be supervised, and patients will be asked to avoid additional exercise training. They will be allowed to perform extra physical activity (e.g., light walking) according to medical recommendations.
Aerobic exercise (Long HIIT)Behavioural
Patients allocated to the Long HIIT will train on a cycle ergometer three days a week for 12 weeks (36 sessions). They will perform from two to four 4-min high-intensity exercise bouts above the second ventilatory threshold separated by 4-min active recovery periods below the first ventilatory threshold. The total time spent at high intensity will range from eight to 16 min. All sessions will be supervised, and patients will be asked to avoid additional exercise training. They will be allowed to perform extra physical activity (e.g., light walking) according to medical recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity training (MIT) group | Experimental | Continuous exercise training on a cycle ergometer Receives: Behavioral: Aerobic exercise (MIT) |
| Short high-intensity interval training (HIIT) group | Experimental | High-intensity interval exercise performed on a cycle ergometer Receives: Behavioral: Aerobic exercise (Short HIIT) |
| Long high-intensity interval training (HIIT) group | Experimental | High-intensity interval exercise performed on a cycle ergometer Receives: Behavioral: Aerobic exercise (Long HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in endothelial function at 7 weeks
Endothelial function (i.e., endothelial-dependent dilation) will be assessed by brachial FMD.
Measured: 7 weeks
Change from baseline in endothelial function at 14 weeks
Endothelial function (i.e., endothelial-dependent dilation) will be assessed by brachial FMD.
Measured: 14 weeks
Change from baseline in endothelial-independent dilation at 7 weeks
Brachial NMD will be used to measure endothelial-independent dilation.
Measured: 7 weeks
Change from baseline in endothelial-independent dilation at 14 weeks
Brachial NMD will be used to measure endothelial-independent dilation.
Measured: 14 weeks
Change from baseline in peak cardiopulmonary parameters at 7 weeks
Participants will perform a symptom-limited CPET on a cycle ergometer.
Measured: 7 weeks
Change from baseline in peak cardiopulmonary parameters at 14 weeks
Participants will perform a symptom-limited CPET on a cycle ergometer.
Measured: 14 weeks
Change from baseline in aerobic efficiency at 7 weeks
Efficiency-related variables will be measured during the CPET.
Measured: 7 weeks
Change from baseline in aerobic efficiency at 14 weeks
Efficiency-related variables will be measured during the CPET.
Measured: 14 weeks
Change from baseline in resting serum BDNF concentration at 7 weeks
Blood samples will be obtained through an indwelling catheter placed in the antecubital vein before the CPET.
Measured: 7 weeks
Change from baseline in resting serum BDNF concentration at 14 weeks
Blood samples will be obtained through an indwelling catheter placed in the antecubital vein before the CPET.
Measured: 14 weeks
Change from baseline in exercise-induced effect on serum BDNF at 7 weeks
Blood samples will be obtained through an indwelling catheter placed in the antecubital vein before and after the CPET.
Measured: 7 weeks
Change from baseline in exercise-induced effect on serum BDNF at 14 weeks
Blood samples will be obtained through an indwelling catheter placed in the antecubital vein before and after the CPET.
Measured: 14 weeks
Secondary outcomes (12)
Change from baseline in pulmonary function at 7 and 14 weeks
Pulmonary function will be measured by spirometry
Measured: 7 and 14 weeks
Change from baseline in resting cardiopulmonary parameters at 7 and 14 weeks
Patients will be asked to rest for 5 min before stating the CPET.
Measured: 7 and 14 weeks
Change from baseline in cardiopulmonary parameters at first and second ventilatory thresholds at 7 and 14 weeks
First and second ventilatory threshold during the CPET will be analysed blindly using the ventilatory equivalents method.
Measured: 7 and 14 weeks
Change from baseline in cardiopulmonary variables measured during the recovery at 7 and 14 weeks.
Cardiopulmonary variables will be measured during the 3-min recovery period of the CPET.
Measured: 7 and 14 weeks
Change from baseline in MacNew domains at 7 and 14 weeks
The MacNew heart disease health-related quality of life instrument will be used as a disease-specific quality of life questionnaire. The MacNew consists of 27 items that fall into three domains (a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale). Scoring of the MacNew is straightforward. The maximum possible score in any domain is 7 (high quality of life) and the minimum is 1 (poor quality of life).
Measured: 7 and 14 weeks
Change from baseline in body composition at 7 and 14 weeks
Bioimpedance assessment will be conducted in fasting state.
Measured: 7 and 14 weeks
Change from baseline in resting heart rate variability (HRV) at 7 and 14 weeks
HRV will be measured after an overnight fasting period at the same time of day
Measured: 7 and 14 weeks
Change from baseline in echocardiographic variables at 7 and 14 weeks
A resting echocardiographic assessment will be performed before starting the CPET. The echocardiographic variables measured will be left ventricular end-diastolic diameter, septal and posterior wall thickness, left atrium dimension and volume, left ventricular ejection fraction (four-chamber and biplane Simpson's method, tricuspid annular plane systolic excursion, S' wave velocity, peak E and A wave velocities (in sinus rhythm), lateral and medial e' velocities, peak tricuspid regurgitation gradient, and velocity and gradient across the aortic valve.
Measured: 7 and 14 weeks
Change from baseline in blood analysis variables at 14 weeks.
Blood samples will be obtained after at least a 10-hours period of fasting.
Measured: 14 weeks
Change from baseline in ability to inhibit cognitive interference at 7 and 14 weeks
The Stroop test will be used to assess the ability to inhibit cognitive interference.
Measured: 7 and 14 weeks
Change from baseline in verbal memory performance at 14 weeks
Verbal learning and memory are assessed using the Rey Auditory Verbal Learning Test (RAVLT) under standardized environmental conditions. The procedure begins with five consecutive learning trials of a 15-word list (List A). The primary measures focus on the recall performance of this list at three key points during the test:
Immediate post-interference recall (A6): After presenting a new distractor list (List B), participants are asked to recall the original List A to assess resistance to interference.
20-minute delayed recall (A7): Assesses short-term retention. During this interval, participants complete the Corsi Block-Tapping Test (a visuospatial task) to prevent mental rehearsal of the words.
24-hour delayed recall (A8): Measures long-term memory consolidation via an unexpected telephone call where participants are asked to recall List A once again.
Measured: 14 weeks
Change from baseline in visuospatial working memory performance at 14 weeks
Visuospatial working memory is assessed using the Corsi Block-Tapping Test. Participants reproduce sequences of tapped blocks in both forward (same order) and backward (reverse order) conditions. Sequence lengths increase progressively until the participant fails two sequences of the same length. The reported outcome includes the Corsi span (defined as the maximum sequence length correctly reproduced) and the total number of correctly reproduced sequences. For both metrics, higher scores indicate better visuospatial working memory performance. This task is administered during the 20-minute interval of the RAVLT to prevent mental rehearsal of verbal material.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Nov 2024
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary Intervention (PCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria y Biomédica de Alicante
- Sponsor type
- Research network
- Collaborators
- Universidad Miguel Hernandez de Elche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788275
- Sponsor's protocol ID
- PI2023/154
- Other IDs
- ISABIAL
- Acronym
- ENDO-R
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Instituto de Investigacion Sanitaria y Biomedica de Alicante (ISABIAL) Community in ZENODO. Depositing in ZENODO allows selecting the type of access for each file (open, embargoed; restricted; closed) and the license for use (Creative Commons Attribution 4.0 International, which requires citing the database and the original study, as well as mentioning any changes made; this is suggested at the institutional level for files identified with open access). It is important to note that the use of ZENODO is temporary, until it is viable to use the REPISALUD repository, from the Carlos III Health Institute, by the ISABIAL research community. At least two different files will be included: i) The one corresponding to the data set; ii) One or more files with complementary information about the characteristics of the variables and/or study metadata (project, authors, related publication, keywords, etc.).
Publications
Fuertes-Kenneally L, Blasco-Peris C, Casanova-Lizon A, Baladzhaeva S, Climent V, Sarabia JM, Manresa-Rocamora A. Effects of high-intensity interval training on vascular function in patients with cardiovascular disease: a systematic review and meta-analysis. Front Physiol. 2023 Jul 27;14:1196665. doi: 10.3389/fphys.2023.1196665. eCollection 2023.
PubMed 37576344
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06788275
- Acronym / sponsor ID
- ENDO-R / PI2023/154
- Conditions
- Percutaneous Coronary Intervention (PCI), Acute Myocardial Infarction, Angina (Stable), Unstable Angina Pectoris, Cardiorespiratory Fitness, Ischaemic Heart Diseases
- Keywords
- Aerobic exercise, High-intensity interval training, Cardiac rehabilitation, Multicenter study, Coronary artery disease, Flow-mediated dilation, Nitroglycerin-mediated dilation, Mortality predictors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria y Biomédica de AlicanteResearch network
- Collaborators
- Universidad Miguel Hernandez de Elche
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity training (MIT) group | Experimental | Behavioral: Aerobic exercise (MIT)Continuous exercise training on a cycle ergometer |
| Short high-intensity interval training (HIIT) group | Experimental | Behavioral: Aerobic exercise (Short HIIT)High-intensity interval exercise performed on a cycle ergometer |
| Long high-intensity interval training (HIIT) group | Experimental | Behavioral: Aerobic exercise (Long HIIT)High-intensity interval exercise performed on a cycle ergometer |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (30 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise (MIT)Also: MITPatients allocated to the MIT group will train on a cycle ergometer three days a week for 12 weeks (36 sessions). They will cycle continuously between the first and second ventilatory thresholds. The duration of each exercise session will be set according to the estimated energy expenditure of the long HIIT and short HIIT groups for each training block (energy expenditure-adjusted exercise sessions). All sessions will be supervised, and patients will be asked to avoid additional exercise. They will be allowed to perform extra physical activity (e.g., light walking) according to medical recommendations. | Behavioural | Moderate-intensity training (MIT) group |
| Aerobic exercise (Short HIIT)Also: Short HIITPatients allocated to the Short HIIT group will train on a cycle ergometer three days a week for 12 weeks (36 sessions). They will perform from two to four 4-repetition sets of 1-min above the second ventilatory threshold. Patients will perform 1- and 3-min active recovery periods below the first ventilatory threshold between repetitions and sets, respectively. The total time spent at high intensity will range from eight to 16 min. All sessions will be supervised, and patients will be asked to avoid additional exercise training. They will be allowed to perform extra physical activity (e.g., light walking) according to medical recommendations. | Behavioural | Short high-intensity interval training (HIIT) group |
| Aerobic exercise (Long HIIT)Patients allocated to the Long HIIT will train on a cycle ergometer three days a week for 12 weeks (36 sessions). They will perform from two to four 4-min high-intensity exercise bouts above the second ventilatory threshold separated by 4-min active recovery periods below the first ventilatory threshold. The total time spent at high intensity will range from eight to 16 min. All sessions will be supervised, and patients will be asked to avoid additional exercise training. They will be allowed to perform extra physical activity (e.g., light walking) according to medical recommendations. | Behavioural | Long high-intensity interval training (HIIT) group |
Primary outcome
Change from baseline in endothelial function at 7 weeks
Time frame: 7 weeks
Endothelial function (i.e., endothelial-dependent dilation) will be assessed by brachial FMD.
Change from baseline in endothelial function at 14 weeks
Time frame: 14 weeks
Endothelial function (i.e., endothelial-dependent dilation) will be assessed by brachial FMD.
Change from baseline in endothelial-independent dilation at 7 weeks
Time frame: 7 weeks
Brachial NMD will be used to measure endothelial-independent dilation.
Change from baseline in endothelial-independent dilation at 14 weeks
Time frame: 14 weeks
Brachial NMD will be used to measure endothelial-independent dilation.
Change from baseline in peak cardiopulmonary parameters at 7 weeks
Time frame: 7 weeks
Participants will perform a symptom-limited CPET on a cycle ergometer.
Change from baseline in peak cardiopulmonary parameters at 14 weeks
Time frame: 14 weeks
Participants will perform a symptom-limited CPET on a cycle ergometer.
Change from baseline in aerobic efficiency at 7 weeks
Time frame: 7 weeks
Efficiency-related variables will be measured during the CPET.
Change from baseline in aerobic efficiency at 14 weeks
Time frame: 14 weeks
Efficiency-related variables will be measured during the CPET.
Change from baseline in resting serum BDNF concentration at 7 weeks
Time frame: 7 weeks
Blood samples will be obtained through an indwelling catheter placed in the antecubital vein before the CPET.
Change from baseline in resting serum BDNF concentration at 14 weeks
Time frame: 14 weeks
Blood samples will be obtained through an indwelling catheter placed in the antecubital vein before the CPET.
Change from baseline in exercise-induced effect on serum BDNF at 7 weeks
Time frame: 7 weeks
Blood samples will be obtained through an indwelling catheter placed in the antecubital vein before and after the CPET.
Change from baseline in exercise-induced effect on serum BDNF at 14 weeks
Time frame: 14 weeks
Blood samples will be obtained through an indwelling catheter placed in the antecubital vein before and after the CPET.
12 secondary outcomes
Change from baseline in pulmonary function at 7 and 14 weeks
Time frame: 7 and 14 weeks
Change from baseline in resting cardiopulmonary parameters at 7 and 14 weeks
Time frame: 7 and 14 weeks
Change from baseline in cardiopulmonary parameters at first and second ventilatory thresholds at 7 and 14 weeks
Time frame: 7 and 14 weeks
Change from baseline in cardiopulmonary variables measured during the recovery at 7 and 14 weeks.
Time frame: 7 and 14 weeks
Change from baseline in MacNew domains at 7 and 14 weeks
Time frame: 7 and 14 weeks
Change from baseline in body composition at 7 and 14 weeks
Time frame: 7 and 14 weeks
Change from baseline in resting heart rate variability (HRV) at 7 and 14 weeks
Time frame: 7 and 14 weeks
Change from baseline in echocardiographic variables at 7 and 14 weeks
Time frame: 7 and 14 weeks
Change from baseline in blood analysis variables at 14 weeks.
Time frame: 14 weeks
Change from baseline in ability to inhibit cognitive interference at 7 and 14 weeks
Time frame: 7 and 14 weeks
Change from baseline in verbal memory performance at 14 weeks
Time frame: 14 weeks
Change from baseline in visuospatial working memory performance at 14 weeks
Time frame: 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 37576344Fuertes-Kenneally L, Blasco-Peris C, Casanova-Lizon A, Baladzhaeva S, Climent V, Sarabia JM, Manresa-Rocamora A. Effects of high-intensity interval training on vascular function in patients with cardiovascular disease: a systematic review and meta-analysis. Front Physiol. 2023 Jul 27;14:1196665. doi: 10.3389/fphys.2023.1196665. eCollection 2023.
- Individual participant dataSharing planned: Yes. The Instituto de Investigacion Sanitaria y Biomedica de Alicante (ISABIAL) Community in ZENODO. Depositing in ZENODO allows selecting the type of access for each file (open, embargoed; restricted; closed) and the license for use (Creative Commons Attribution 4.0 International, which requires citing the database and the original study, as well as mentioning any changes made; this is suggested at the institutional level for files identified with open access). It is important to note that the use of ZENODO is temporary, until it is viable to use the REPISALUD repository, from the Carlos III Health Institute, by the ISABIAL research community. At least two different files will be included: i) The one corresponding to the data set; ii) One or more files with complementary information about the characteristics of the variables and/or study metadata (project, authors, related publication, keywords, etc.).
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Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated With Percutaneous Coronary Intervention
Ischemia, Myocardial, Coronary Artery Disease
RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
Integrated Assessment, Immune-Inflammatory
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise (MIT), Aerobic exercise (Short HIIT) and Aerobic exercise (Long HIIT) in people with Percutaneous Coronary Intervention (PCI) and Acute Myocardial Infarction, run by Instituto de Investigación Sanitaria y Biomédica de Alicante at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Manuel Sarabia, PhD (965222568, jsarabia@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in endothelial function at 7 weeks (time frame: 7 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.