The Norwegian Trial of Physical Exercise After Myocardial Infarction (NorEx)

Norwegian University of Science and Technology

Status: Invitation-only

Conditions: Myocardial Infarction

Treatments: Behavioral: Observation group; Behavioral: Physical exercise; Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04617639

287380 (Other Grant/Funding Number)

12128

287618 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 9,700 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Norwegian national identification number
3. Able to communicate in Norwegian or other Scandinavian language
4. Being able to be physically active according to study protocol, as determined by study personnel.
5. Signed informed consent.

Exclusion criteria

1. 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.
2. Participating or plans to participate in endurance sport competitions.
3. Expected to emigrate during the study
4. Cognitive impairment/dementia.
5. Alcohol or drug abuse, or serious psychiatric disease.
6. 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.
7. Renal insufficiency requiring dialysis.
8. 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.
9. Inability to comply with the study protocol due to any physical disability, somatic disease or mental problem, as determined by study personnel.
10. Residing in nursing home or other institution.
11. Participation in another trial with exercise as an intervention modality.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9,700 participants in 3 patient groups

Physical exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Physical exercise

Control group I

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard care

Control group II (observation group)

Other group

Description:

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

Treatment:

Behavioral: Observation group