Clinical trial NCT04617639: The Norwegian Trial of Physical Exercise After Myocardial Infarction
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myocardial Infarction
Keywords: Exercise therapy
Secondary prevention
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital Health Authority
name: Oslo Universitetssykehus Hospital Trust
name: Universitetssykehuset i Nord-Norge Hospital Trust
name: Helse Bergen Hospital Trust
name: Helse Sorlandet Hospital Trust
name: Finnmark Hospital Trust
name: Helgelandssykehuset Hospital Trust
name: Nordlandssykehuset Hospital Trust
name: Helse Fonna Hospital Trust
name: Helse Forde Hospital Trust
name: Helse Møre og Romsdal Hospital Trust
name: Helse Nord-Trøndelag HF
name: Akershus University Hospital Trust
name: Diakonhjemmet Hospital AS
name: Sykehuset Innlandet Hospital Trust
name: Sykehuset Telemark Hospital Trust
name: Sykehuset i Vestfold Hospital Trust
name: Helse Stavanger Hospital Trust
name: Vestre Viken Hospital Trust
name: Helse Midt-Norge Hospital Trust
name: University of Oslo
name: University of Bergen
name: University of Tromso
name: Haraldsplass Hospital AS
name: Lovisenberg Hospital AS
name: Sykehuset Ostvold Hospital Trust
First posted: 2020-11-05
Enrollment: 9700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial with blinded endpoint evaluation
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first.
timeFrame: 4 years
Secondary outcomes:
measure: Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first.
timeFrame: 10 years
measure: Time to all-cause mortality, cardiac death, vascular death, noncardiovascular death, death from cancer.
timeFrame: 4 years and 10 years
measure: 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.
timeFrame: 4 years and 10 years
measure: Change in health related quality of life
timeFrame: Study start, 4 years and 10 years
measure: Change in anxiety and depression
timeFrame: Study start, 4 and 10 years
measure: Physical and mental dimensions of health
timeFrame: Study start, 4 years and 10 years
measure: Changes in insomnia
timeFrame: Study start, 4 years and 10 years
measure: The number of consultations with a primary health care physician during the study
timeFrame: 4 and 10 years
measure: Use of prescription drugs
timeFrame: 4 and 10 years
measure: Change in memory
timeFrame: 4 and 10 years
measure: Change in peak oxygen uptake (VO2peak) (mL/kg/min)
timeFrame: Study start, 1 year, 4 years
measure: Physical activity
timeFrame: Study start, 4 years, 10 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital Clinic of Cardiology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Øystein Risa
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Kaare Bønaa, MD prof
role: PRINCIPAL_INVESTIGATOR
References: