The Norwegian Trial of Physical Exercise After Myocardial Infarction

NCT04617639 | Enrolling By Invitation DMC

• 3 other identifiers: 12128287618287380
• Study Type: interventional
• Target: 9,700
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Exercise therapy; Secondary prevention

Outcome Measures

Primary Outcomes (1)

• Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first.

  Mortality will be assessed by linkage to the Norwegian Cause of Death Register with the use of a unique 11-digit Norwegian national identification number for each patient. The Cause of Death Register is completed by law for all deaths. Nonfatal myocardial infarction and nonfatal stroke are assessed by linkage to The Norwegian Myocardial Infarction Register and the Norwegian Stroke Register, with the use of a unique 11-digit Norwegian national identification number for each patient. All Norwegian hospitals are required by law to complete these registers for hospitalized patients.

  4 years

Secondary Outcomes (12)

• Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first.

  10 years

• Time to all-cause mortality, cardiac death, vascular death, noncardiovascular death, death from cancer.

  4 years and 10 years

• Time to hospitalization with a diagnosis of nonfatal myocardial infarction, stroke, unstable angina pectoris, atrial fibrillation, or psychiatric disease, or a coronary revascularization procedure, or any hospitalization.

  4 years and 10 years

• Change in health related quality of life

  Study start, 4 years and 10 years

• Change in anxiety and depression

  Study start, 4 and 10 years

Study Arms (3)

Physical exercise

EXPERIMENTAL

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: Physical exercise

Control group I

ACTIVE COMPARATOR

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: Standard care

Control group II (observation group)

OTHER

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

Behavioral: Observation group

Interventions

Physical exercise 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.

Physical exercise

Standard care 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 I

Observation group BEHAVIORAL

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

Control group II (observation group)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Residing in nursing home or other institution.
• Participation in another trial with exercise as an intervention modality.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Universitetssykehuset i Nord-Norge Hospital Trust: collaborator
• Helse Bergen Hospital Trust: collaborator
• Helse Sorlandet Hospital Trust: collaborator
• Finnmark Hospital Trust: collaborator
• Helgelandssykehuset Hospital Trust: collaborator
• Nordlandssykehuset Hospital Trust: collaborator
• Helse Fonna Hospital Trust: collaborator
• Helse Forde Hospital Trust: collaborator
• Helse Møre og Romsdal Hospital Trust: collaborator
• Helse Nord-Trøndelag HF: collaborator
• Akershus University Hospital Trust: collaborator
• Diakonhjemmet Hospital AS: collaborator
• Sykehuset Innlandet Hospital Trust: collaborator
• Sykehuset Telemark Hospital Trust: collaborator
• Sykehuset i Vestfold Hospital Trust: collaborator
• Helse Stavanger Hospital Trust: collaborator
• Vestre Viken Hospital Trust: collaborator
• Helse Midt-Norge Hospital Trust: collaborator
• University of Oslo: collaborator
• University of Bergen: collaborator
• University of Tromso: collaborator
• Haraldsplass Hospital AS: collaborator
• Lovisenberg Hospital AS: collaborator
• Sykehuset Ostvold Hospital Trust: collaborator
• St. Olavs Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

St Olavs Hospital Clinic of Cardiology

Trondheim, Norway

Location

Related Publications (1)

• Svenningsen A, Soderstrom S, Bucher Sandbakk S, Gullestad L, Bonaa KH, Wisloff U, Hollekim-Strand SM. Mind the intention-behavior gap: a qualitative study of post-myocardial infarction patients' beliefs and experiences with long-term supervised and self-monitored physical exercise. BMC Sports Sci Med Rehabil. 2024 Sep 27;16(1):204. doi: 10.1186/s13102-024-00987-2.

  PMID: 39334432 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Øystein Risa

  Norwegian University of Science and Technology

  STUDY DIRECTOR

• Kaare Bønaa, MD prof

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized controlled trial with blinded endpoint evaluation

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 5, 2020
• Study Start: September 29, 2020
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2036
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)