心筋梗塞の高齢患者における身体活動介入 (PIpELINe)

All patients randomized to health education received a single in-person visit, one month post discharge, which included a 30-minute counselling session, supported by educational materials and tailoring of the medical treatment. The educational material provided standardized recommendations on diet, smoking cessation, and physical activity. Quality of life, functional capacity and home physical activity are assessed by proper tools.

Current gold standard in older patients admitted to hospital for MI. The group will receive a 20-minute session with one of the study physicians. Both the patient and relatives will attend these sessions. The study physician will stress the major issues related to a heart-healthy lifestyle and will explain the importance of PA as a powerful and independent factor to improve cardiovascular health and minimize cardiovascular risk. A detailed brochure explaining the benefits of physical activity will be provided to all patients

All patients randomized to experimental arm will receive diet counselling, aggressive control of CV risk factors, smoke cessation program and exercise training. The physical activity (PA) intervention will start the program with a supervised PA session immediately after the inclusion visit. Quality of life, functional capacity and daily activities will be assessed by proper tools. The program provides 6 supervised PA sessions (30, 60, 90, 180, 270 and 360 days after hospital discharge [T0]). At the end of each supervised session, calisthenics exercises derived from Otago Exercise Program are prescribed.

The intervention includes diet counselling, smoke cessation program, aggressive CV risk control and PA intervention. The PA intervention consisted of supervised sessions combined with an individualized home-based PA program. Centre-based sessions will be supervised by a sports physician and a nurse, and will take approximately 30 to 40 minutes, including a moderate standardized treadmill-walk, and strength and balance exercises. Based on the practice sessions, patients will receive a walking program to perform at home, unsupervised. The PA programs will be individualized, and consistent with current international recommendations. A selection of calisthenic exercises will be prescribed. Participants will be encouraged to perform the exercises three times per week (approximately 20 minutes). Adjustment of the type and intensity of the home-based PA regimen will be made at each visit. The PA program will be extensively described to the patient and family members.

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of 1-year composite endpoint of cardiovascular death plus hospital readmission for cardiovascular cause.

To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of all-cause death

To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of all-cause death

To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of cardiovascular death

To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of cardiovascular death

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for cardiovascular cause.

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of composite endpoint of hospital readmission for cardiovascular cause.

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of composite endpoint of cardiovascular death plus hospital readmission for cardiovascular cause.

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for heart failure

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for heart failure

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for myocardial infarction

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for myocardial infarction

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for coronary revascularization

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for coronary revascularization

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of cerebrovascular accident

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of cerebrovascular accident

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any cause

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any cause

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any non-cardiovascular cause

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any non-cardiovascular cause

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of bleeding adverse events

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of bleeding adverse events

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (SPPB ranges from 0 to 12, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (SPPB ranges from 0 to 12, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (SPPB ranges from 0 to 12, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (handgrip strength, ranges from 0 to infinity, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (handgrip strength, ranges from 0 to infinity, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (handgrip strength, ranges from 0 to infinity, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (10 meters gait speed ranges from 0 to infinity, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (10 meters gait speed ranges from 0 to infinity, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of physical performance (10 meters gait speed ranges from 0 to infinity, higher values mean better physical performance)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of quality of life (EQ5D VAS points)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of quality of life (EQ5D VAS points)

To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of quality of life (EQ5D VAS points)