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

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ClinicalTrials.gov Identifier: NCT02627586
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE December 1, 2015
First Posted Date  ICMJE December 11, 2015
Last Update Posted Date December 5, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2015)
Left ventricular end diastolic volume [ Time Frame: week 3 ]
Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.
Change History Complete list of historical versions of study NCT02627586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2015)
  • 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.
  • Global longitudinal strain [ Time Frame: week 3, 12, and 65 ]
    Standard transthoracic echocardiography with Speckle tracking will be performed.
  • Left ventricular end systolic volume [ Time Frame: week 3, 12, and 65 ]
    Standard transthoracic echocardiography will be performed.
  • Left ventricular ejection fraction [ Time Frame: week 3, 12, and 65 ]
    Standard transthoracic echocardiography will be performed.
  • 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.
  • 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)
  • 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.
  • Vascular function [ Time Frame: week 3, 12, and 65 ]
    Vascular function will be determined by measurement of arterial stiffness.
  • 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.
  • Leg muscle function [ Time Frame: week 3, 12, and 65 ]
    Jumping mechanography will be performed using a mobile force plate.
  • 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.
  • Quality of life [ Time Frame: week 3, 12, and 65 ]
    Short form quality of life questionnaire (SF36)
  • Quality of life with heart failure [ Time Frame: week 3, 12, and 65 ]
    Minnesota living with heart failure questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 8, 2015)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE High-Intensity Interval Training Early After Left Ventricular Myocardial Infarction
Official Title  ICMJE High Intensity Interval Training & Early Adverse Remodelling After Left Ventricular mYocardial Infarction (HIIT-EARLY): A Randomized Controlled Exercise Intervention Study
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • 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 Name: High intensity interval training
  • 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 Name: Moderate intensity continuous exercise
Study Arms  ICMJE
  • 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.
    Intervention: Other: MICE
  • 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.

    Intervention: Other: HIIT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 8, 2015)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lukas Trachsel, MD +41 31 6328970 lukas.trachsel@insel.ch
Contact: Matthias Wilhelm, MD +41 31 6328970 matthias.wilhelm@insel.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02627586
Other Study ID Numbers  ICMJE HIIT-EARLY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lukas Trachsel, MD Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne
PRS Account University Hospital Inselspital, Berne
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP