The Norwegian Trial of Physical Exercise After Myocardial Infarction

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.

Time frame: 10 years

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

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.

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.

Information about hospitalizations and the discharge diagnoses will be collected by means of electronic linkage to the Norwegian Patient Registry with the use of a unique 11-digit Norwegian national identification number for each patient. The Norwegian National Patient Registry includes the codes of the International Classification of Diseases, 10th Revision (ICD-10), with respect to all the main diagnoses and up to 20 secondary diagnoses and all the procedure codes from all hospitalizations in Norway.

Time frame: 4 years and 10 years

Change in health related quality of life

HeartQoL questionnaire is a core ischemic heart disease specific health related quality of life questionnaire (HRQL). The questionnaire comprises 14-items with 10-item physical and 4-item emotional subscales which are scored from 0 (poor HRQL) to 3 (better HRQL) with a global score if need.

Time frame: Study start, 4 years and 10 years

Change in anxiety and depression

The Hospital Anxiety and Depression Scale (HADS) measure symptoms of anxiety and depression. The HADS is a 14 item scale where seven of the items relate to anxiety and seven relate to depression.The respondent rates each item on a 4-point scale from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).

Time frame: Study start, 4 and 10 years

Physical and mental dimensions of health

RAND-12 measures physical and mental dimensions of health. The 12 items in the questionnaire correspond to eight principal physical and mental health domains. The 12 items are summarized into two scores, a "Physical Health Summary Measure (PCS-physical component score)" and a "Mental Health Summary Measure (MCS-mental component score). .

Time frame: Study start, 4 years and 10 years

Changes in insomnia

The Bergen Insomnia Scale measure sleeping pattern and insomnia. The 6 items in the questionnaire are scored from 0 (absence) to 7 (every night) and are summarized to a total score with a max value between 0 (no insomnia) to 42 (extreme insomnia).

Time frame: Study start, 4 years and 10 years

The number of consultations with a primary health care physician during the study

The number of consultations in primary health care will be collected by linkage to the Norwegian KUHR database with the use of a unique 11-digit Norwegian national identification number for each patient.

Time frame: 4 and 10 years

Use of prescription drugs

Use of prescription drugs during the study will be collected by linkage to the Norwegian Drug Prescription Database with the use of a unique 11-digit Norwegian national identification number for each patient.

Time frame: 4 and 10 years

Change in memory

The following 8 questions about memory will be administered by a self-administered questionnaire at start of the study and after 3.5 year and 10 years: 1. Do you have problems with the memory? 2. Are these problems worse than among other people on your age? 3. Do have problems with remembering other persons name? 4. Do have problems with following a conversation? 5. Do have problems with remembering what happened a few minutes ago? 6. Do have problems with doing what you have planned to do? 7 Do have problems with remembering dates? 8\. Do have problems with remembering events that took place a few days ago? The response categories for all questions are: "Never (0)", "Little or sometimes (1)", or "Often (2)". The scores for question 3 to 8 may be summarized to a total score between 0 (No memory problems) and 18 (severe memory problems).

Time frame: 4 and 10 years

Change in peak oxygen uptake (VO2peak) (mL/kg/min)

Peak oxygen uptake will be measured with standard equipment for indirect calorimetry in an incremental protocol until exhaustion on either a treadmill or a bicycle ergometer. Measurements will be performed each year during the study in random samples of 150 participants in the experimental physical exercise arm and 150 participants in the active comparator arm (control group I)

Time frame: Study start, 1 year, 4 years

Physical activity

A self-administered questionnaire with questions about frequency of weekly physical activity, intensity level, and amount of weekly physical activity will be administered at baseline and end of study (3.5 years). The questionnaire consist of the following 6 questions: How many times do you exercise per week? (4 response categories). If you exercise 1 time or more per week, at what intensity level do you usually exercise (3 response categories). How many minutes do you usually exercise each time (4 response categories) How many hours per day do you spend in a sitting position ( number of hours) Do you participate in endurance sport competitions? (no, yes)

Time frame: Study start, 4 years, 10 years