High-Intensity Interval Training Early After Left Ventricular Myocardial Infarction (HIIT-EARLY)

December 10, 2020 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Berne, Switzerland, 3010
        • Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moderate intensity continuous exercise
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.
Other: 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.
Other Names:
  • Moderate intensity continuous exercise
Experimental: High-intensity interval training

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.
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.
Other Names:
  • High intensity interval training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 12, and 65
Global longitudinal strain
Time Frame: week 3, 12, and 65
Standard transthoracic echocardiography with Speckle tracking will be performed.
week 3, 12, and 65
Left ventricular end systolic volume
Time Frame: week 3, 12, and 65
Standard transthoracic echocardiography will be performed.
week 3, 12, and 65
Left ventricular ejection fraction
Time Frame: week 3, 12, and 65
Standard transthoracic echocardiography will be performed.
week 3, 12, and 65
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.
week 3, 12, and 65
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)
week 3, 12, and 65
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.
week 1, 3, 12, and 65
Vascular function
Time Frame: week 3, 12, and 65
Vascular function will be determined by measurement of arterial stiffness.
week 3, 12, and 65
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.
week 3, 12, and 65
Leg muscle function
Time Frame: week 3, 12, and 65
Jumping mechanography will be performed using a mobile force plate.
week 3, 12, and 65
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.
week 3, 12, and 65
Quality of life
Time Frame: week 3, 12, and 65
Short form quality of life questionnaire (SF36)
week 3, 12, and 65
Quality of life with heart failure
Time Frame: week 3, 12, and 65
Minnesota living with heart failure questionnaire
week 3, 12, and 65

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 4 and 12
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.
week 4 and 12
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.
week 4 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Lukas Trachsel, MD, Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

November 11, 2020

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIIT-EARLY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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