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

Overview

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.

Interventions

• Behavioral 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 abo
• 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.
• Behavioral Observation group
  Follow-up through mandatory national heath registries for primary endpoint, without any contact by study personnel

Primary outcome measures

• Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first. [Time frame: 4 years]

Secondary outcome measures (12)

• Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first. [Time frame: 10 years]
• Time to all-cause mortality, cardiac death, vascular death, noncardiovascular death, death from cancer. [Time frame: 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. [Time frame: 4 years and 10 years]
• Change in health related quality of life [Time frame: Study start, 4 years and 10 years]
• Change in anxiety and depression [Time frame: Study start, 4 and 10 years]
• Physical and mental dimensions of health [Time frame: Study start, 4 years and 10 years]
• Changes in insomnia [Time frame: Study start, 4 years and 10 years]
• The number of consultations with a primary health care physician during the study [Time frame: 4 and 10 years]
• Use of prescription drugs [Time frame: 4 and 10 years]
• Change in memory [Time frame: 4 and 10 years]
• Change in peak oxygen uptake (VO2peak) (mL/kg/min) [Time frame: Study start, 1 year, 4 years]
• Physical activity [Time frame: Study start, 4 years, 10 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Norway · 1 center

• St Olavs Hospital Clinic of Cardiology — Trondheim

Publications

• 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

Identifiers

NCT: NCT04617639 · 12128 · 287618 · 287380

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗