An interventional study of Aerobic exercise (MIT) and Aerobic exercise (Short HIIT) in Percutaneous Coronary Intervention (PCI), Acute Myocardial Infarction and Angina (Stable), sponsored by Instituto de Investigación Sanitaria y Biomédica de Alicante. Recruiting at 2 sites in Spain. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Instituto de Investigación Sanitaria y Biomédica de Alicante · Not applicable, Interventional, and Treatment
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.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 132 is below the median of 150 across 230 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →Instituto de Investigación Sanitaria y Biomédica de Alicante is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continuous exercise training on a cycle ergometer
Behavioral: Aerobic exercise (MIT)
High-intensity interval exercise performed on a cycle ergometer
Behavioral: Aerobic exercise (Short HIIT)
High-intensity interval exercise performed on a cycle ergometer
Behavioral: Aerobic exercise (Long HIIT)
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.
Also known as: MIT
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.
Also known as: Short 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.
Change from baseline in endothelial function at 7 weeks
Endothelial function (i.e., endothelial-dependent dilation) will be assessed by brachial FMD.
Time frame: 7 weeks
Change from baseline in endothelial function at 14 weeks
Endothelial function (i.e., endothelial-dependent dilation) will be assessed by brachial FMD.
Time frame: 14 weeks
Change from baseline in endothelial-independent dilation at 7 weeks
Brachial NMD will be used to measure endothelial-independent dilation.
Time frame: 7 weeks
Change from baseline in endothelial-independent dilation at 14 weeks
Brachial NMD will be used to measure endothelial-independent dilation.
Time frame: 14 weeks
Change from baseline in peak cardiopulmonary parameters at 7 weeks
Participants will perform a symptom-limited CPET on a cycle ergometer.
Time frame: 7 weeks
Change from baseline in peak cardiopulmonary parameters at 14 weeks
Participants will perform a symptom-limited CPET on a cycle ergometer.
Time frame: 14 weeks
Change from baseline in aerobic efficiency at 7 weeks
Efficiency-related variables will be measured during the CPET.
Time frame: 7 weeks
Change from baseline in aerobic efficiency at 14 weeks
Efficiency-related variables will be measured during the CPET.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 weeks
Change from baseline in pulmonary function at 7 and 14 weeks
Pulmonary function will be measured by spirometry
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 7 and 14 weeks
Change from baseline in body composition at 7 and 14 weeks
Bioimpedance assessment will be conducted in fasting state.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 weeks
Plan to share: 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.).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: From November 2027 to November 2030
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Instituto de Investigación Sanitaria y Biomédica de Alicante