NCT04617639Active, not recruiting
The Norwegian Trial of Physical Exercise After Myocardial Infarction
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 9513 (actual)
- First submitted
- 21 Oct 2020
- Start date
- 29 Sept 2020
- Primary completion date
- 19 May 2025
- Lead sponsor
- Norwegian University of Science and Technology
- Diseases
- Coronary artery disease
- NCT number
- NCT04617639
What you commit to
- Study type: Interventional
- Participants enrolled: 9513
- From 29 Sept 2020 to the primary completion date, 19 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Other
- 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
- Residing in nursing home or other institution.
- Participation in another trial with exercise as an intervention modality.
Who the study is looking for
- 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.
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Olavs Hospital Clinic of Cardiology Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.