Background
Methods
Study population
Inclusion criteria | |
---|---|
• Age ≥ 70 years | |
• Hospital admission for acute coronary syndrome (ACS) and coronary artery angiography ± percutaneous coronary intervention | ACS is defined in presence of the following criteria (the first mandatory and at least one between criterion 2 and 3): 1. Chest pain suggestive of cardiac origin lasting at least 20 min 2. ECG changes compatibles with signs of myocardial ischemia 3. Detection of rise of cardiac biomarkers |
• Informed consent • SPPB score 4–9 at the inclusion visit (T1) | |
Exclusion criteria | |
• Short portable mental status questionnaire (SPMSQ) < 4 | SPMSQ is performed as first test. If it results less than 4 the patient is excluded |
• Life expectancy < 12 months | |
• The patient is not discharged at home, but he/she is transferred from the cardiology unit to other hospital unit or community structure • Chronic heart failure NYHA III-IV. • Left ventricle ejection fraction < 30%. • Severe aortic or mitral valvulopathy • Multivessel coronary artery disease or left main coronary artery disease candidate to CABG • Planned staged PCI • Impossibility to perform physical activity due to physical impairment |
Clinical management and study flow
Randomization
Control group (standard of care)
Interventional group (tailored physical activity intervention)
Inclusion visit (T1) | Home-based program | Following activity sessions (60 ± 10, 90 ± 10 and 120 ± 10 days after T0) |
---|---|---|
Pre-test: • measure of blood pressure • positioning RS100 Polar heart rate monitor to constantly evaluate heart rate • Calisthenics exercises | • 30 to 60 min of continuous moderate walking a day, at least 3 to 4 and preferably 7 days a week • Calisthenics exercisesb | Pre-test: • Measure of blood pressure • Positioning RS100 Polar heart rate monitor to constantly evaluate heart rate. • Evaluation of data recorded by accelerometer. • Calisthenics exercisesb |
Start: walking on the level at 2.0 km/h | Start: walking at an updated intensity estabilished according to reached results in the previous activity session | |
Every 30 s: increases of 0.3 km/h up to reach a walking speed corresponding to a perceived exertion of 11–13 on the Borg scale for 1 kma. | Every 30 s: increases of 0.3 km/h up to reach a walking speed corresponding to a perceived exertion of 11–13 on the Borg scale for 1 kma. | |
Post-test: • Measure of blood pressure. • Counselling on physical activity and daily activities, such as gardening, or household work. • Distribution of home accelerometer | Post-test: • Measure of blood pressure • Counselling on physical activity and daily activities, such as gardening, or household work. • Distribution of home accelerometer |
Study visits and follow-up
Primary endpoint
Secondary endpoints
Handgrip strength (HGT)
EuroQol-5D, Quality of life questionnaire
Advanced Activity Daily Living (aADL)
7-Day Physical Activity Recall Questionnaire (PAR)
Adverse events
6 month after T0 | 1, 2 and 3 years after T0 | |
---|---|---|
Primary endpoint | ||
• SPPB score |
X
| |
Secondary Endpoints | ||
• SPPB score |
X
| |
• Handgrip test |
X
| |
• All-cause mortality |
X
| |
• Cardiovascular mortality |
X
| |
• All-cause re-hospitalization |
X
| |
• Cardiovascular re-hospitalization |
X
| |
• aADL score |
X
|
X
|
• PAR Questionnaire |
X
|
X
|
• LDL- cholesterol level |
X
| |
• EQ-5D score |
X
|
X
|
• Glycated Haemoglobin (HbA1C) level |
X
|
X
|
• On treatment platelet reactivity |
X
|
X
|
• Nuisance bleedings |
X
|
X
|