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NCT Number: NCT02627586

High-Intensity Interval Training Early After Left Ventricular Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Remodeling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne

Bern, 3010, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIIT

Other

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.

Other names: High intensity interval training

MICE

Other

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.

Other names: Moderate intensity continuous exercise

Primary outcomes

  1. Left ventricular end diastolic volume

    Time frame: week 12

    Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.

Secondary outcomes

  1. Left ventricular end diastolic volume

    Time frame: week 12, and 65

    Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.

  2. Global longitudinal strain

    Time frame: week 3, 12, and 65

    Standard transthoracic echocardiography with Speckle tracking will be performed.

  3. Left ventricular end systolic volume

    Time frame: week 3, 12, and 65

    Standard transthoracic echocardiography will be performed.

  4. Left ventricular ejection fraction

    Time frame: week 3, 12, and 65

    Standard transthoracic echocardiography will be performed.

  5. Pulse wave tissue Doppler imaging of the mitral annulus velocity (E')

    Time frame: week 3, 12, and 65

    Standard transthoracic echocardiography with tissue Doppler imaging will be performed.

  6. Cardiac stress markers

    Time frame: week 3, 12, and 65

    Blood samples are analysed for markers of cardiac 'stress' (NT-pro BNP, Troponin T hs)

  7. Peak oxygen uptake of maximal cardiopulmonary exercise test

    Time frame: 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.

  8. Vascular function

    Time frame: week 3, 12, and 65

    Vascular function will be determined by measurement of arterial stiffness.

  9. Leg muscle volume and function

    Time frame: week 3, 12, and 65

    Muscle cross-sectional area (CSA) will be assessed with peripheral computed tomography (pQCT) at the thigh.

  10. Leg muscle function

    Time frame: week 3, 12, and 65

    Jumping mechanography will be performed using a mobile force plate.

  11. Heart rate variability

    Time frame: 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.

  12. Quality of life

    Time frame: week 3, 12, and 65

    Short form quality of life questionnaire (SF36)

  13. Quality of life with heart failure

    Time frame: week 3, 12, and 65

    Minnesota living with heart failure questionnaire

Other outcomes

  1. Cardiac stress markers

    Time frame: week 4 and 12

    Blood samples for determination of markers of atrial and ventricular 'stress' (NT-pro Brain Natriuretic Peptide, Troponin T hs) are taken after a training session.

  2. Inflammation markers

    Time frame: week 4 and 12

    Blood samples for determination of markers of inflammation (hs C-reactive protein, Interleukin 6) are taken after a training session.

  3. Heart rate variability

    Time frame: week 4 and 12

    Heart 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.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: HIIT-EARLY

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Dec 11, 2015
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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