Myocardial InfarctionHIIT-EARLYNCT02627586
High-Intensity Interval Training Early After Left Ventricular Myocardial Infarction
A study testing HIIT and MICE in people with Myocardial Infarction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- HIIT and MICE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to 11 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first ST-segment elevation myocardial infarction (STEMI)
- Percutaneous intervention within the preceding 4 week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne
Bern, 3010
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Myocardial Infarction
- Being tested
- HIIT, MICE
- Keywords
- exercise therapy, left ventricular remodeling, ventricular ejection fraction, high-intensity interval training
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
Also called 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 50-60% of peak heart rate). The total duration of the HIIT training is 38 min.
MICEOther
Also called Moderate intensity continuous exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular end diastolic volume
Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.
Measured: week 12
Secondary outcomes (13)
Left ventricular end diastolic volume
Standard transthoracic echocardiography will be performed. Left ventricular (LV) volumes will be calculated using the biplane Simpson's method.
Measured: week 12, and 65
Global longitudinal strain
Standard transthoracic echocardiography with Speckle tracking will be performed.
Measured: week 3, 12, and 65
Left ventricular end systolic volume
Standard transthoracic echocardiography will be performed.
Measured: week 3, 12, and 65
Left ventricular ejection fraction
Standard transthoracic echocardiography will be performed.
Measured: week 3, 12, and 65
Pulse wave tissue Doppler imaging of the mitral annulus velocity (E')
Standard transthoracic echocardiography with tissue Doppler imaging will be performed.
Measured: week 3, 12, and 65
Cardiac stress markers
Blood samples are analysed for markers of cardiac 'stress' (NT-pro BNP, Troponin T hs)
Measured: week 3, 12, and 65
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.
Measured: week 1, 3, 12, and 65
Vascular function
Vascular function will be determined by measurement of arterial stiffness.
Measured: week 3, 12, and 65
Leg muscle volume and function
Muscle cross-sectional area (CSA) will be assessed with peripheral computed tomography (pQCT) at the thigh.
Measured: week 3, 12, and 65
Leg muscle function
Jumping mechanography will be performed using a mobile force plate.
Measured: week 3, 12, and 65
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.
Measured: week 3, 12, and 65
Quality of life
Short form quality of life questionnaire (SF36)
Measured: week 3, 12, and 65
Quality of life with heart failure
Minnesota living with heart failure questionnaire
Measured: week 3, 12, and 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJun 2015
- Primary completion31 Dec 2019
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas Trachsel, MD, Principal investigator, Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627586
- Sponsor's protocol ID
- HIIT-EARLY
- Acronym
- HIIT-EARLY
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2015
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21937520Bochenek 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.
PubMed 22000785Rognmo 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.
PubMed 15179103Kemi 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.
PubMed 15949480Marcin 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.
PubMed 33450366
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training & Early Adverse Remodelling After Left Ventricular mYocardial Infarction (HIIT-EARLY): A Randomized Controlled Exercise Intervention Study
- ClinicalTrials.gov ID
- NCT02627586
- Acronym / sponsor ID
- HIIT-EARLY / HIIT-EARLY
- Conditions
- Myocardial Infarction
- Keywords
- exercise therapy, left ventricular remodeling, ventricular ejection fraction, high-intensity interval training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate intensity continuous exercise | Active comparator | Other: MICEModerate 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. |
| High-intensity interval training | Experimental | Other: HIITHigh-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first ST-segment elevation myocardial infarction (STEMI)
- Percutaneous intervention within the preceding 4 week
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIITAlso: High intensity interval trainingHigh-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 | High-intensity interval training |
| MICEAlso: Moderate intensity continuous exerciseMICE 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 | Moderate intensity continuous exercise |
Primary outcome
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.
13 secondary outcomes
Left ventricular end diastolic volume
Time frame: week 12, and 65
Global longitudinal strain
Time frame: week 3, 12, and 65
Left ventricular end systolic volume
Time frame: week 3, 12, and 65
Left ventricular ejection fraction
Time frame: week 3, 12, and 65
Pulse wave tissue Doppler imaging of the mitral annulus velocity (E')
Time frame: week 3, 12, and 65
Cardiac stress markers
Time frame: week 3, 12, and 65
Peak oxygen uptake of maximal cardiopulmonary exercise test
Time frame: week 1, 3, 12, and 65
Vascular function
Time frame: week 3, 12, and 65
Leg muscle volume and function
Time frame: week 3, 12, and 65
Leg muscle function
Time frame: week 3, 12, and 65
Heart rate variability
Time frame: week 3, 12, and 65
Quality of life
Time frame: week 3, 12, and 65
Quality of life with heart failure
Time frame: week 3, 12, and 65
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Background: PubMed 21937520Moholdt 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.
- Background: PubMed 22000785Bochenek 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.
- Background: PubMed 15179103Rognmo 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.
- Background: PubMed 15949480Kemi 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.
- Derived from this study: PubMed 33450366Marcin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Trachsel, MD principal investigator
Preventive Cardiology & Sports Medicine, University Clinic for Cardiology, University Hospital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and MICE in people with Myocardial Infarction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular end diastolic volume (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627586, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.