High-Intensity Interval Training Early After Left Ventricular Myocardial Infarction

NCT02627586 | Completed DMC

• 1 other identifier: HIIT-EARLY
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

exercise therapy; left ventricular remodeling; ventricular ejection fraction; high-intensity interval training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Left ventricular end diastolic volume

  week 12, and 65

• Global longitudinal strain

  week 3, 12, and 65

• Left ventricular end systolic volume

  week 3, 12, and 65

• Left ventricular ejection fraction

  week 3, 12, and 65

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

  week 3, 12, and 65

Other Outcomes (3)

• Cardiac stress markers

  week 4 and 12

• Inflammation markers

  week 4 and 12

• Heart rate variability

  week 4 and 12

Study Arms (2)

Moderate intensity continuous exercise

ACTIVE COMPARATOR

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

High-intensity interval training

EXPERIMENTAL

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

Interventions

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.

Also known as: High intensity interval training

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.

Also known as: Moderate intensity continuous exercise

Moderate intensity continuous exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first ST-segment elevation myocardial infarction (STEMI)
• Percutaneous intervention within the preceding 4 week

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

Location

Related Publications (5)

• Moholdt T, Aamot IL, Granoien I, Gjerde L, Myklebust G, Walderhaug L, Brattbakk L, Hole T, Graven T, Stolen TO, Amundsen BH, Molmen-Hansen HE, Stoylen A, Wisloff U, Slordahl 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.

  PMID: 21937520 BACKGROUND

• Bochenek T, Wita K, Tabor Z, Grabka M, Krzych L, Wrobel 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.

  PMID: 22000785 BACKGROUND

• Rognmo O, Hetland E, Helgerud J, Hoff J, Slordahl 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. doi: 10.1097/01.hjr.0000131677.96762.0c.

  PMID: 15179103 BACKGROUND

• Kemi OJ, Haram PM, Loennechen JP, Osnes JB, Skomedal T, Wisloff U, Ellingsen O. Moderate vs. high exercise intensity: differential effects on aerobic fitness, cardiomyocyte contractility, and endothelial function. Cardiovasc Res. 2005 Jul 1;67(1):161-72. doi: 10.1016/j.cardiores.2005.03.010. Epub 2005 Apr 20.

  PMID: 15949480 BACKGROUND

• Marcin T, Trachsel LD, Dysli M, Schmid JP, Eser P, Wilhelm M. Effect of self-tailored high-intensity interval training versus moderate-intensity continuous exercise on cardiorespiratory fitness after myocardial infarction: A randomised controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101490. doi: 10.1016/j.rehab.2021.101490. Epub 2021 Nov 21.

  PMID: 33450366 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Ventricular Remodeling

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lukas Trachsel, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 11, 2015
• Study Start: June 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: November 11, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

CH (1)