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High-Intensity Interval Training Early After Left Ventricular Myocardial Infarction

High Intensity Interval Training & Early Adverse Remodelling After Left Ventricular mYocardial Infarction (HIIT-EARLY): A Randomized Controlled Exercise Intervention Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02627586
Acronym
HIIT-EARLY
Enrollment
75
Registered
2015-12-11
Start date
2015-06-30
Completion date
2020-11-11
Last updated
2020-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

exercise therapy, left ventricular remodeling, ventricular ejection fraction, high-intensity interval training

Brief summary

Several studies have shown that high-intensity interval training (HIIT) is more effective than moderate-intensity continuous exercise training (MICE) at improving functional capacity and quality of life in stable cardiac patients and can be performed safely. However, its effect on patients after recent myocardial infarction is currently unknown. In these patients avoidance of a negative remodeling after an acute myocardial infarction is of upmost importance. Therefore, assessment of the influence of HIIT on post-infarct left ventricular-remodeling is urgently needed. Therefore, the aim of this study is to determine the effect of HIIT on left ventricular (LV) remodeling (measured by LV end diastolic volume) compared to the effect of the more established MICE training modality. Further measurements include other parameters of LV remodeling (LV contractility, and brain natriuretic peptide), prognostic parameters (peak oxygen uptake, exercise capacity), cardiac output, endothelial function, leg muscle function and scores of quality of life. Further, certain blood parameters and heart rate variability measured by electro-cardiogram are measured to assess the safety of this type of training. Patients with first ST-segment elevation myocardial infarction (STEMI) or equivalent with onset of symptoms of ischemia and treated by primary percutaneous intervention within the preceding 4 weeks will be included. The HIIT and MICE is integrated in a 12-week exercise training program at the Inselspital Bern, consisting of 1) exercise training, 2) nutrition counselling and 3) psychotherapy. The exercise program will comprise 3 weekly exercise sessions lasting 90 minutes, supervised by experienced exercise therapists. The program focuses on endurance type exercises, strengthening and relaxation exercises as well as exercises to improve coordination skills. In the first 3 weeks (run-in-phase), all patients will complete three weekly MICE sessions. In the following 9 weeks, patients randomized to the intervention group will perform two weekly HIIT sessions and one MICE session per week. The control group will continue with three weekly MICE sessions for the 9 week intervention phase. A total of 144 patients will be recruited. Measurements will be performed at baseline, after a 3-week run-in-phase, and after the 9-week intervention phase. Safety measurements will be performed during the 4th and 12th week.

Detailed description

Background Several studies have shown that high-intensity interval training (HIIT) is more effective than moderate-intensity continuous exercise training (MICE) at improving functional capacity and quality of life in stable cardiac patients and can be performed safely. It has therefore emerged as a new and important exercise modality in cardiac rehabilitation centres all over Europe for stable heart failure patients with LV dysfunction. Its safety and efficacy has not yet been tested in patients with acute LV dysfunction due to a myocardial infarction. In clinical practice, the difference between acute and chronic left ventricular dysfunction is often not made and patients with a condition after a recent myocardial infarction and LV dysfunction might be offered the same training regimens as patients with chronic heart failure, including HIIT, although its effect on post-infarction remodeling is unknown. On the other hand, avoidance of a negative remodeling after an acute myocardial infarction is of upmost importance. Therefore, assessment of the influence of HIIT on post-infarct LV-remodeling is urgently needed. Objective To determine the effect of HIIT on left ventricular remodelling (measured by end diastolic volume) compared to the effect of the more established MICE training modality in patients after a recent myocardial infarction and LV dysfunction. Methods After a 3-week run-in phase with MICE only training for all patients, patients randomised to the HIIT group will perform two HIIT and one MICE session per week while the MICE group performs 3 MICE sessions per week. Outcomes will be assessed before and after the 9-week intervention. End diastolic volume will be measured by 2-dimensional echography, peak oxygen uptake (peak VO2) and exercise capacity by cardiopulmonary exercise testing on a cycle ergometer, quality of life by questionnaires, vascular function by arterial stiffness measurement, leg muscle cross-sectional area by peripheral quantitative computed tomography, and leg muscle function by jumping mechanography. During the 4th and the 12th week of the rehabilitation training, heart rate variability will be measured in the morning following training, and blood samples will be taken after a training session to analyse markers of myocardial stress (Troponin T, MR-proANP, BNP).

Interventions

OTHERHIIT

High-intensity interval training (HIIT) is performed on a cycle ergometer. It consists of a 10 min warm-up followed by 4 min intervals in Zone III (at 90-95% of peak heart rate), with each interval separated by 3 min of active pauses in zone I (at 50-60% of peak heart rate). The total duration of the HIIT training is 38 min.

OTHERMICE

MICE is also performed on a cycle ergometer at an intensity of 50-80% of peak VO2 or 60-75% of peak heart rate for 47 min (in order for the two training protocols to be isocaloric). The control group will perform MICE training three times per week.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* first ST-segment elevation myocardial infarction (STEMI) * Percutaneous intervention within the preceding 4 week

Exclusion criteria

* inability to participate in a 3-month training program * contraindication to maximal exercise test (CPET) * known chronic heart failure with LV ejection fraction ≤45% before the acute index event * angiographically documented significant coronary stenosis (\> 50%) at randomization * medical condition which would prevent a patient from performing high intensity training * permanent atrial fibrillation * alcohol or drug abuse * inability to follow the procedures of the study

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular end diastolic volumeweek 12Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.

Secondary

MeasureTime frameDescription
Cardiac stress markersweek 3, 12, and 65Blood samples are analysed for markers of cardiac 'stress' (NT-pro BNP, Troponin T hs)
Heart rate variabilityweek 3, 12, and 65Heart rate variability will be continuously recorded during 5 min in supine position and 5 min standing after an orthostatic challenge using an ECG monitor.
Quality of lifeweek 3, 12, and 65Short form quality of life questionnaire (SF36)
Quality of life with heart failureweek 3, 12, and 65Minnesota living with heart failure questionnaire
Left ventricular end diastolic volumeweek 12, and 65Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.
Global longitudinal strainweek 3, 12, and 65Standard transthoracic echocardiography with Speckle tracking will be performed.
Left ventricular end systolic volumeweek 3, 12, and 65Standard transthoracic echocardiography will be performed.
Left ventricular ejection fractionweek 3, 12, and 65Standard transthoracic echocardiography will be performed.
Pulse wave tissue Doppler imaging of the mitral annulus velocity (E')week 3, 12, and 65Standard transthoracic echocardiography with tissue Doppler imaging will be performed.
Peak oxygen uptake of maximal cardiopulmonary exercise testweek 1, 3, 12, and 65Cardiopulmonary exercise testing (CPET) will be performed on a cycle ergometer. Respiratory parameters \[oxygen (O2) consumption, carbon dioxide (CO2) production\] will be measured continuously.
Vascular functionweek 3, 12, and 65Vascular function will be determined by measurement of arterial stiffness.
Leg muscle volume and functionweek 3, 12, and 65Muscle cross-sectional area (CSA) will be assessed with peripheral computed tomography (pQCT) at the thigh.
Leg muscle functionweek 3, 12, and 65Jumping mechanography will be performed using a mobile force plate.

Other

MeasureTime frameDescription
Heart rate variabilityweek 4 and 12Heart rate variability will be continuously recorded during 5 min in supine position and 5 min standing after an orthostatic challenge in the morning following a training session.
Inflammation markersweek 4 and 12Blood samples for determination of markers of inflammation (hs C-reactive protein, Interleukin 6) are taken after a training session.
Cardiac stress markersweek 4 and 12Blood samples for determination of markers of atrial and ventricular 'stress' (NT-pro Brain Natriuretic Peptide, Troponin T hs) are taken after a training session.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026