The Norwegian Trial of Physical Exercise After Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

9700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2036-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled trial with blinded endpoint evaluation

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Physical exercise

Intervention Type BEHAVIORAL

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.

Control group I

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.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

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.

Control group II (observation group)

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

Group Type OTHER

Observation group

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Observation group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No