High-Intensity Interval Training Early After Left Ventricular Myocardial Infarction
- Conditions
- Myocardial Infarction
- Interventions
- Other: HIITOther: MICE
- Registration Number
- NCT02627586
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-intensity interval training HIIT 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 50-70% of peak heart rate). The total duration of the HIIT training is 38 min. Moderate intensity continuous exercise (MICE) is also performed on a cycle ergometer at an intensity of 50-80% of peak VO2 or 60-85% of peak heart rate for 38 min (including a 5 min warm-up and 3 min cool-down). This group performs two HIIT sessions and one MICE session per week. In both training forms cycling resistance will be adjusted weekly according to heart rate and Borg scale. Moderate intensity continuous exercise MICE Moderate intensity continuous exercise (MICE) is performed on a cycle ergometer at an intensity of 50-80% of peak VO2 or 60-85% of peak heart rate for 38 min (including a 5 min warm-up and 3 min cool-down). This group will perform MICE training three times per week. Cycling resistance will be adjusted weekly according to heart rate and Borg scale.
- Primary Outcome Measures
Name Time Method Left ventricular end diastolic volume week 12 Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.
- Secondary Outcome Measures
Name Time Method Leg muscle function week 3, 12, and 65 Jumping mechanography will be performed using a mobile force plate.
Left ventricular end diastolic volume week 12, and 65 Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.
Left ventricular end systolic volume week 3, 12, and 65 Standard transthoracic echocardiography will be performed.
Leg muscle volume and function week 3, 12, and 65 Muscle cross-sectional area (CSA) will be assessed with peripheral computed tomography (pQCT) at the thigh.
Heart rate variability week 3, 12, and 65 Heart rate variability will be continuously recorded during 5 min in supine position and 5 min standing after an orthostatic challenge using an ECG monitor.
Global longitudinal strain week 3, 12, and 65 Standard transthoracic echocardiography with Speckle tracking will be performed.
Cardiac stress markers week 3, 12, and 65 Blood samples are analysed for markers of cardiac 'stress' (NT-pro BNP, Troponin T hs)
Peak oxygen uptake of maximal cardiopulmonary exercise test week 1, 3, 12, and 65 Cardiopulmonary exercise testing (CPET) will be performed on a cycle ergometer. Respiratory parameters \[oxygen (O2) consumption, carbon dioxide (CO2) production\] will be measured continuously.
Quality of life with heart failure week 3, 12, and 65 Minnesota living with heart failure questionnaire
Pulse wave tissue Doppler imaging of the mitral annulus velocity (E') week 3, 12, and 65 Standard transthoracic echocardiography with tissue Doppler imaging will be performed.
Quality of life week 3, 12, and 65 Short form quality of life questionnaire (SF36)
Left ventricular ejection fraction week 3, 12, and 65 Standard transthoracic echocardiography will be performed.
Vascular function week 3, 12, and 65 Vascular function will be determined by measurement of arterial stiffness.
Trial Locations
- Locations (1)
Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne
🇨🇭Berne, Switzerland