High-Intensity Interval Training Early After Left Ventricular Myocardial Infarction

Myocardial Infarction Clinical Trial

— HIIT-EARLY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627586
• Other study ID #: HIIT-EARLY
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 11, 2020

Study information

• Verified date: December 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 11, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• 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 50-60% of peak heart rate). The total duration of the HIIT training is 38 min.
• MICE
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.

Locations

Country	Name	City	State
Switzerland	Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Bochenek T, Wita K, Tabor Z, Grabka M, Krzych L, Wróbel W, Berger-Kucza A, Elzbieciak M, Doruchowska A, Gluza MT. Value of speckle-tracking echocardiography for prediction of left ventricular remodeling in patients with ST-elevation myocardial infarction treated by primary percutaneous intervention. J Am Soc Echocardiogr. 2011 Dec;24(12):1342-8. doi: 10.1016/j.echo.2011.09.003. Epub 2011 Oct 14. — View Citation

Kemi OJ, Haram PM, Loennechen JP, Osnes JB, Skomedal T, Wisløff U, Ellingsen Ø. Moderate vs. high exercise intensity: differential effects on aerobic fitness, cardiomyocyte contractility, and endothelial function. Cardiovasc Res. 2005 Jul 1;67(1):161-72. Epub 2005 Apr 20. — View Citation

Moholdt T, Aamot IL, Granøien I, Gjerde L, Myklebust G, Walderhaug L, Brattbakk L, Hole T, Graven T, Stølen TO, Amundsen BH, Mølmen-Hansen HE, Støylen A, Wisløff U, Slørdahl SA. Aerobic interval training increases peak oxygen uptake more than usual care exercise training in myocardial infarction patients: a randomized controlled study. Clin Rehabil. 2012 Jan;26(1):33-44. doi: 10.1177/0269215511405229. Epub 2011 Sep 21. — View Citation

Rognmo Ø, Hetland E, Helgerud J, Hoff J, Slørdahl SA. High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2004 Jun;11(3):216-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac stress markers	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.	week 4 and 12
Other	Inflammation markers	Blood samples for determination of markers of inflammation (hs C-reactive protein, Interleukin 6) are taken after a training session.	week 4 and 12
Other	Heart rate variability	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.	week 4 and 12
Primary	Left ventricular end diastolic volume	Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.	week 12
Secondary	Left ventricular end diastolic volume	Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.	week 12, and 65
Secondary	Global longitudinal strain	Standard transthoracic echocardiography with Speckle tracking will be performed.	week 3, 12, and 65
Secondary	Left ventricular end systolic volume	Standard transthoracic echocardiography will be performed.	week 3, 12, and 65
Secondary	Left ventricular ejection fraction	Standard transthoracic echocardiography will be performed.	week 3, 12, and 65
Secondary	Pulse wave tissue Doppler imaging of the mitral annulus velocity (E')	Standard transthoracic echocardiography with tissue Doppler imaging will be performed.	week 3, 12, and 65
Secondary	Cardiac stress markers	Blood samples are analysed for markers of cardiac 'stress' (NT-pro BNP, Troponin T hs)	week 3, 12, and 65
Secondary	Peak oxygen uptake of maximal cardiopulmonary exercise test	Cardiopulmonary exercise testing (CPET) will be performed on a cycle ergometer. Respiratory parameters [oxygen (O2) consumption, carbon dioxide (CO2) production] will be measured continuously.	week 1, 3, 12, and 65
Secondary	Vascular function	Vascular function will be determined by measurement of arterial stiffness.	week 3, 12, and 65
Secondary	Leg muscle volume and function	Muscle cross-sectional area (CSA) will be assessed with peripheral computed tomography (pQCT) at the thigh.	week 3, 12, and 65
Secondary	Leg muscle function	Jumping mechanography will be performed using a mobile force plate.	week 3, 12, and 65
Secondary	Heart rate variability	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.	week 3, 12, and 65
Secondary	Quality of life	Short form quality of life questionnaire (SF36)	week 3, 12, and 65
Secondary	Quality of life with heart failure	Minnesota living with heart failure questionnaire	week 3, 12, and 65