NCT04617639

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 9,700 (estimated)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
BEHAVIORAL	Physical exercise	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.
BEHAVIORAL	Standard care	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.
BEHAVIORAL	Observation group	Follow-up through mandatory national heath registries for primary endpoint, without any contact by study personnel

Timeline

• Start date: 2020-09-29
• Primary completion: 2028-07-31
• Completion: 2036-12-31
• First posted: 2020-11-05
• Last updated: 2025-07-10

Locations

1 site across 1 country: Norway