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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

The Norwegian trial of Physical Exercise After Myocardial Infarction - NorEx

Alternative title: Helseeffekter ved fysisk trening etter hjerteinfarkt - NorEx

Awarded: NOK 20.0 mill.

Regular physical activity is recommended both to prevent cardiovascular disease in healthy persons and to prevent recurrence or worsening in people already affected by such diseases. However, the scientific evidence for these recommendations is weak, and in reality, we do not know whether previously untrained people have permanent health benefits from starting physical exercise. We will conduct a large intervention trial with a sound scientific design that to examine whether physical activity improves life expectancy, reduces the risk of heart disease, and enhance quality of life among people who have had a heart attack. The study will last for 4 years and will include 9 700 patients. Participants are randomly allocated to a group that will receive supervised physical training throughout the study period or to two control groups that are given usual advice on physical activity. The hypothesis is that supervised physical exercise leads to a 20% reduction in mortality and major cardiovascular disease. In addition, we will examine whether physical exercise affects the risk cancer, mental health, and quality of life. The study has a design that utilizes Norwegian health registers and other unique Norwegian comparative advantages and is led by a research group with longtime experience in studies of physical activity and large randomized multi-center studies. The study is the largest trial ever conducted in this field, and the first study with a potential to find out whether physical activity affects life expectancy and quality of life, and to determine how large such effects may be. The study will provide a clear answer to a question that is of major importance both in clinical medicine as well as for public health. The study findings may have implications for medical practice. A total of 7657 patients are included in the NorEx trial as of November 23. 2023. Base on current inclusion rates, we expect that a total of 9 700 will be included by July 2024. All patients will be followed up for at least 3 years. The final results will be reported in 2028.

Observational studies have consistently shown that a low level of physical activity (PA) is associated with increased risk of all-cause mortality and cardiovascular morbidity, both in the general population, and in patients with cardiovascular disease (CVD). However, the evidence for recommending inactive persons to increase their level of PA may not be as strong as has been previously thought as no randomized trial has been conducted to show whether PA may prevent the risk for CVD, and secondary prevention trials among patients with CVD were either of insufficient quality or found no effect of PA on total mortality, risk of a new MI, or revascularization. There is a striking inconsistency between the clear results from observational studies and the weak or absent evidence from randomized trials, and any causal relation between PA and cardiovascular mortality and morbidity is still not clear. We propose to conduct a large randomized secondary prevention trial among patients who have experienced a MI. The trial will be a collaboration between hospital and community health care services, universities, and competence centers.The patients will be randomized to supervised moderate to vigorous PA or to standard advice regarding PA, and we will compare the long-term effects on mortality, morbidity and quality of life. By following 9 690 participants 4.0 to 6.5 years (medium 4.9 years) - with more than 47 000 person-years of observation - this will be the largest randomized trial conducted in this field. The trial will be the first trial with sufficient statistical power to resolve an important clinical question with global relevance. The project utilizes major Norwegian advantages, including each inhabitant's unique personal identification number that enables follow-up of the participant's health outcome in a number of high-quality national health registers. A large biobank will foster translational research in to increase understanding of how PA influences health.

Funding scheme:

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering