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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 9,700
- 试验地点
- 1
- 主要终点
- Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized in a Norwegian hospital with an acute myocardial infarction (Type I) during 2013-
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Physical exercise (Behavioral)
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.
干预措施: Standard care (Behavioral)
Control group II (observation group)
Follow-up through mandatory national heath registries for primary endpoint, without any contact by study personnel.
干预措施: Observation group (Behavioral)
结局指标
主要结局
Time to all-cause mortality, or nonfatal myocardial infarction, or nonfatal stroke, whichever comes first.
时间窗: 4 years
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.
次要结局
- Change in memory(4 and 10 years)
- Changes in insomnia(Study start, 4 years and 10 years)
- 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)
- Physical and mental dimensions of health(Study start, 4 years and 10 years)
- The number of consultations with a primary health care physician during the study(4 and 10 years)
- Use of prescription drugs(4 and 10 years)
- Change in peak oxygen uptake (VO2peak) (mL/kg/min)(Study start, 1 year, 4 years)
- Physical activity(Study start, 4 years, 10 years)