The Norwegian Trial of Physical Exercise After Myocardial Infarction

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

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 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

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

Sponsors & Collaborators

• Universitetssykehuset i Nord-Norge Hospital Trust

  collaborator UNKNOWN

• Helse Bergen Hospital Trust

  collaborator UNKNOWN

• Helse Sorlandet Hospital Trust

  collaborator UNKNOWN

• Finnmark Hospital Trust

  collaborator OTHER

• Helgelandssykehuset Hospital Trust

  collaborator UNKNOWN

• Nordlandssykehuset Hospital Trust

  collaborator UNKNOWN

• Helse Fonna Hospital Trust

  collaborator UNKNOWN

• Helse Forde Hospital Trust

  collaborator UNKNOWN

• Helse Møre og Romsdal Hospital Trust

  collaborator UNKNOWN

• Helse Nord-Trøndelag HF

  collaborator OTHER

• Akershus University Hospital Trust

  collaborator UNKNOWN

• Diakonhjemmet Hospital AS

  collaborator UNKNOWN

• Sykehuset Innlandet Hospital Trust

  collaborator UNKNOWN

• Sykehuset Telemark Hospital Trust

  collaborator UNKNOWN

• Sykehuset i Vestfold Hospital Trust

  collaborator UNKNOWN

• Helse Stavanger Hospital Trust

  collaborator UNKNOWN

• Vestre Viken Hospital Trust

  collaborator OTHER

• Helse Midt-Norge Hospital Trust

  collaborator UNKNOWN

• University of Oslo

  collaborator OTHER

• University of Bergen

  collaborator OTHER

• University of Tromso

  collaborator OTHER

• Haraldsplass Hospital AS

  collaborator UNKNOWN

• Lovisenberg Hospital AS

  collaborator UNKNOWN

• Sykehuset Ostvold Hospital Trust

  collaborator UNKNOWN

• St. Olavs Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Øystein Risa · Norwegian University of Science and Technology

• Kaare Bønaa, MD prof · Norwegian University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-29

Primary Completion

2028-07-31

Completion

2036-12-31

Countries

• Norway

Study Locations