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Myocardial InfarctionNorExNCT04617639

The Norwegian Trial of Physical Exercise After Myocardial Infarction

A study testing Physical exercise and Observation group in people with Myocardial Infarction, run by Norwegian University of Science and Technology at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Myocardial infarction (MI) remains the main cause of death in Europe with about 2 million deaths annually. According to WHO, 30 % of deaths caused by MI could be prevented if the populations adhere to official guidelines for physical activity. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Physical exercise and Observation group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,513 participants
Where
1 siteNorway
Study dates
29 Sep 2020to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hospitalized in a Norwegian hospital with an acute myocardial infarction (Type I) during 2013-2022. Patients are included minimum 3 months after hospitalization when they are in a stable clinical condition.
  • Norwegian national identification number
  • Able to communicate in Norwegian or other Scandinavian language
  • Being able to be physically active according to study protocol, as determined by study personnel.
  • Signed informed consent.

Who cannot join

  • Persons who already participate in physical activity at a similar or higher level than what is prescribed for the intervention group, as determined by study personnel.
  • Participating or plans to participate in endurance sport competitions.
  • Expected to emigrate during the study
  • Cognitive impairment/dementia.
  • Alcohol or drug abuse, or serious psychiatric disease.
  • Known cardiac disease that may represent a contraindication for moderate or high-intensity physical activity, such as symptomatic valvular heart disease, hypertrophic cardiomyopathy, uncontrolled hypertension, in-compensated heart failure, serious arrythmia not under control after treatment, pulmonary hypertension, significant angina after revascularization and optimal drug treatment.
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  • Renal insufficiency requiring dialysis.
  • Any end-stage somatic disease with short life expectancy or that is expected to interfere with the participants' ability to comply with the study protocol, such as advanced cancer, chronic lung disease with exacerbations, or other disease, as determined by study personnel.
  • Inability to comply with the study protocol due to any physical disability, somatic disease or mental problem, as determined by study personnel.
  • Residing in nursing home or other institution.
  • Participation in another trial with exercise as an intervention modality.

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • St Olavs Hospital Clinic of Cardiology

    Trondheim

Other trials in Norway

About this study

Official title: The Norwegian Trial of Physical Exercise After Myocardial Infarction. A Nationwide Randomized Clinical Trial After Myocardial Infarction to Determine the Effects of Supervised Physical Activity on Long-term Mortality and Morbidity

Myocardial infarction (MI) remains the main cause of death in Europe with about 2 million deaths annually. According to WHO, 30 % of deaths caused by MI could be prevented if the populations adhere to official guidelines for physical activity. However, secondary prevention trials in MI patients have been of insufficient size or quality to provide conclusive evidence that physical activity reduces the risk of death or recurrent cardiovascular diseases. NorEx is the first study able to provide such evidence.

NorEx is a registry-based prospective, three-arm, randomized multicenter secondary prevention clinical trial with blinded end-point evaluation (PROBE design). The aim of the study is to investigate whether, and to what extent, moderate to high intensity supervised physical activity will reduce the risk of recurrent cardiovascular disease and death among people who have suffered a myocardial infarction. The intervention group consists of Approximately 3185 participants who will be trained to exercise for 4 years under supervision of a personal trainer. The study design includes two control groups each consisting of approximately 3200 patients.The primary composite endpoint is time to all-cause death, nonfatal acute myocardial infarction or nonfatal stroke, whatever comes first during 4 years of follow-up. The study is powered to detect a 20 % difference in the incidence of the primary endpoint between the intervention group and the control groups. Novel health IT technology was specifically designed for NorEx, including a smart watch, a NorEx mobile application and a manager portal which allows the trainers to interact with the participants. Follow-up of the participants will be through national health registries for up to 10 years after study completion.

Being tested
Physical exercise, Standard care, Observation group
Keywords
Exercise therapy, Secondary prevention
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exerciseBehavioural

    Supervised home-based and community-based physical exercise with a dose required to increase cardiorespiratory fitness, i.e. intensity, duration and frequency that accumulates to at least 115 minutes a week of exercise, divided into at least 20 minutes a week of high/vigorous intensity physical activity (active minutes at about 85% of peak heart rate or Rated Perceived Exertion [RPE] of about 16 on Borg scale) and 95 minutes a week at moderate-intensity physical activity (active minutes at about 70% of peak heart rate or RPE of about 13 on Borg Scale), or continuous heart rate measurements amounting to at least 100 Personal Activity Intelligence (PAI) equivalents per week.

  • Standard careBehavioural

    Standard care, i.e. advice at study start to follow international guidelines of moderate to vigorous physical activity intensity without further guidance and follow-up by study personnel.

  • Observation groupBehavioural

    Follow-up through mandatory national heath registries for primary endpoint, without any contact by study personnel

Study groups in NCT04617639
Study groupRoleWhat they receive
Physical exerciseExperimentalSupervised home-based and community-based physical exercise with a dose required to increase cardiorespiratory fitness, i.e. intensity, duration and frequency that accumulates to at least 115 minutes a week of exercise, divided into at least 20 minutes a week of high/vigorous intensity physical activity (active minutes at about 85% of peak heart rate or Rated Perceived Exertion [RPE] of about 16 on Borg scale) and 95 minutes a week at moderate-intensity physical activity (active minutes at about 70% of peak heart rate or RPE of about 13 on Borg Scale), or continuous heart rate measurements amounting to at least 100 Personal Activity Intelligence (PAI) equivalents per week.
Receives: Behavioral: Physical exercise
Control group IActive comparatorStandard care, i.e. advice at study start to follow international guidelines of moderate to vigorous physical activity intensity without further guidance and follow-up by study personnel.
Receives: Behavioral: Standard care
Control group II (observation group)OtherFollow-up through mandatory national heath registries for primary endpoint, without any contact by study personnel.
Receives: Behavioral: Observation group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first.

    Mortality will be assessed by linkage to the Norwegian Cause of Death Register with the use of a unique 11-digit Norwegian national identification number for each patient. The Cause of Death Register is completed by law for all deaths. Nonfatal myocardial infarction and nonfatal stroke are assessed by linkage to The Norwegian Myocardial Infarction Register and the Norwegian Stroke Register, with the use of a unique 11-digit Norwegian national identification number for each patient. All Norwegian hospitals are required by law to complete these registers for hospitalized patients.

    Measured: 4 years

Secondary outcomes (12)
  1. Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first.

    Mortality will be assessed by linkage to the Norwegian Cause of Death Register with the use of a unique 11-digit Norwegian national identification number for each patient. The Cause of Death Register is completed by law for all deaths. Nonfatal myocardial infarction and nonfatal stroke are assessed by linkage to The Norwegian Myocardial Infarction Register and the Norwegian Stroke Register, with the use of a unique 11-digit Norwegian national identification number for each patient. All Norwegian hospitals are required by law to complete these registers for hospitalized patients.

    Measured: 10 years

  2. Time to all-cause mortality, cardiac death, vascular death, noncardiovascular death, death from cancer.

    Mortality will be assessed by linkage to the Norwegian Cause of Death Register with the use of a unique 11-digit Norwegian national identification number for each patient. The Cause of Death Register is completed by law for all deaths.

    Measured: 4 years and 10 years

  3. Time to hospitalization with a diagnosis of nonfatal myocardial infarction, stroke, unstable angina pectoris, atrial fibrillation, or psychiatric disease, or a coronary revascularization procedure, or any hospitalization.

    Information about hospitalizations and the discharge diagnoses will be collected by means of electronic linkage to the Norwegian Patient Registry with the use of a unique 11-digit Norwegian national identification number for each patient. The Norwegian National Patient Registry includes the codes of the International Classification of Diseases, 10th Revision (ICD-10), with respect to all the main diagnoses and up to 20 secondary diagnoses and all the procedure codes from all hospitalizations in Norway.

    Measured: 4 years and 10 years

  4. Change in health related quality of life

    HeartQoL questionnaire is a core ischemic heart disease specific health related quality of life questionnaire (HRQL). The questionnaire comprises 14-items with 10-item physical and 4-item emotional subscales which are scored from 0 (poor HRQL) to 3 (better HRQL) with a global score if need.

    Measured: Study start, 4 years and 10 years

  5. Change in anxiety and depression

    The Hospital Anxiety and Depression Scale (HADS) measure symptoms of anxiety and depression. The HADS is a 14 item scale where seven of the items relate to anxiety and seven relate to depression.The respondent rates each item on a 4-point scale from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).

    Measured: Study start, 4 and 10 years

  6. Physical and mental dimensions of health

    RAND-12 measures physical and mental dimensions of health. The 12 items in the questionnaire correspond to eight principal physical and mental health domains. The 12 items are summarized into two scores, a "Physical Health Summary Measure (PCS-physical component score)" and a "Mental Health Summary Measure (MCS-mental component score).

    .

    Measured: Study start, 4 years and 10 years

  7. Changes in insomnia

    The Bergen Insomnia Scale measure sleeping pattern and insomnia. The 6 items in the questionnaire are scored from 0 (absence) to 7 (every night) and are summarized to a total score with a max value between 0 (no insomnia) to 42 (extreme insomnia).

    Measured: Study start, 4 years and 10 years

  8. The number of consultations with a primary health care physician during the study

    The number of consultations in primary health care will be collected by linkage to the Norwegian KUHR database with the use of a unique 11-digit Norwegian national identification number for each patient.

    Measured: 4 and 10 years

  9. Use of prescription drugs

    Use of prescription drugs during the study will be collected by linkage to the Norwegian Drug Prescription Database with the use of a unique 11-digit Norwegian national identification number for each patient.

    Measured: 4 and 10 years

  10. Change in memory

    The following 8 questions about memory will be administered by a self-administered questionnaire at start of the study and after 3.5 year and 10 years:

    1. Do you have problems with the memory?
    2. Are these problems worse than among other people on your age?
    3. Do have problems with remembering other persons name?
    4. Do have problems with following a conversation?
    5. Do have problems with remembering what happened a few minutes ago?
    6. Do have problems with doing what you have planned to do? 7 Do have problems with remembering dates?
    7. Do have problems with remembering events that took place a few days ago? The response categories for all questions are: "Never (0)", "Little or sometimes (1)", or "Often (2)".

    The scores for question 3 to 8 may be summarized to a total score between 0 (No memory problems) and 18 (severe memory problems).

    Measured: 4 and 10 years

  11. Change in peak oxygen uptake (VO2peak) (mL/kg/min)

    Peak oxygen uptake will be measured with standard equipment for indirect calorimetry in an incremental protocol until exhaustion on either a treadmill or a bicycle ergometer. Measurements will be performed each year during the study in random samples of 150 participants in the experimental physical exercise arm and 150 participants in the active comparator arm (control group I)

    Measured: Study start, 1 year, 4 years

  12. Physical activity

    A self-administered questionnaire with questions about frequency of weekly physical activity, intensity level, and amount of weekly physical activity will be administered at baseline and end of study (3.5 years). The questionnaire consist of the following 6 questions:

    How many times do you exercise per week? (4 response categories). If you exercise 1 time or more per week, at what intensity level do you usually exercise (3 response categories).

    How many minutes do you usually exercise each time (4 response categories) How many hours per day do you spend in a sitting position ( number of hours) Do you participate in endurance sport competitions? (no, yes)

    Measured: Study start, 4 years, 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start29 Sep 2020
  3. Primary completion19 May 2025
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled trial with blinded endpoint evaluation
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
9,513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617639
Sponsor's protocol ID
12128
Other IDs
287618, 287380
Acronym
NorEx
Status last verified
Oct 2026
First submitted
21 Oct 2020
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: To be decided

Publications

  • Svenningsen A, Soderstrom S, Bucher Sandbakk S, Gullestad L, Bonaa KH, Wisloff U, Hollekim-Strand SM. Mind the intention-behavior gap: a qualitative study of post-myocardial infarction patients' beliefs and experiences with long-term supervised and self-monitored physical exercise. BMC Sports Sci Med Rehabil. 2024 Sep 27;16(1):204. doi: 10.1186/s13102-024-00987-2.

    PubMed 39334432

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise and Observation group in people with Myocardial Infarction, run by Norwegian University of Science and Technology at 1 site in Norway.

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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. 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 Norway. 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?

This study is still under way. Results are not available in the source record yet.

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?

Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first. (time frame: 4 years). 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 NCT04617639, which also lists 1 linked publication.

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 19 Oct 2026.

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