Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome: a Randomized Clinical Trial (The HULK Pilot Study).

BACKGROUND Physical activity helps to prevent stroke, type II diabetes mellitus and coronary artery disease, while physical inactivity has been linked to declines in both muscle strength and cardiovascular function. Despite the evidence of the benefits of physical activity are well known, 61% of adults over the age of 65 are not meeting the recommended levels of physical activity. It has been demonstrated that regular physical exercise benefits in primary and secondary prevention in patients with cardiovascular diseases and improves functional capacity. The incidence of cardiovascular disease is higher in older patients (especially over 75 years old). In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50 years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%, respectively, due to more effective therapies and lower mortality of many diseases. So, as recommended by guidelines, physical activity should be suggested to older coronary patients; some studies demonstrated the benefit of physical training also in older patients, but only few studies enrolled patients aged 65 years and over because of some difficulties about patients' compliance mainly due to logistic problems and lack of motivation by doctors. As far as we know no studies have evaluated impact of physical activity intervention on functional capacity of older patients admitted to hospital for acute coronary syndrome. Among the numerous tests proposed in the literature for the functional evaluation and objective measures of physical capability in elderly patient, the Short Physical Performance Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those characterized by an improved prognostic ability and an easy administration.

RATIONALE AND OBJECTIVE OF THE STUDY Patients with low functional capacity (frail patients) with cardiovascular disease, in particular those undergoing invasive procedures or suffering from coronary artery disease, have a much higher adverse events, death and re-hospitalizations. and complications, suggesting the need for a more accurate functional stratification and a more careful evaluation of the risk/benefit ratio of some invasive procedures. An early and ad hoc physical activity intervention could be improve functional autonomy of these patients early after discharge with benefit on long-term outcome. The present study is performed to assess the impact, evaluated by Short Physical Performance Battery (SPPB), of a program of physical activity early after discharge in elderly patients aged 75 years and older with low physical performance.

STUDY DESIGN This is an interventional, multicenter, prospective, randomized, phase III study. The present study is expected to enroll elderly patients admitted to hospital for acute coronary syndrome undergoing percutaneous coronary angioplasty and stratified with SPPB score predischarge. At the moment of discharge there will be a screening: patients with SPPB score 0-2 o 10-12 will be exclusively followed up by clinical visit every year. Patients with SPPB score 3-9 will be evaluated during the inclusion visit when SPPB will be repeated. If SPPB score will be 0-3 or 10-12, patients will be considered screening failure and will be followed up by clinical visit; patients with SPPB score between 4 to 9 will be randomized to standard of care (see below) or to an ad hoc physical activity program (see below). The aim of the study is to demonstrate 6 months later an improvement in the SPPB score (at least 1 point) in patients randomized to physical activity intervention versus patients randomized to standard of care. All patients will be evaluated until 3 years after randomization.

RANDOMIZATION

At discharge an investigator doctor and a study coordinator show to patients the study protocol, aims, risks and benefit. If the patient accepts to participate to the study, he signs the informed consent and he will be evaluated with SPPB score and other tests in the screening evaluation (T0). Patients with SPPB score <3 or >9 will be excluded and will be followed up with exclusively clinical visit every year. Patients with SPPB score 4-9 will be enrolled and data will be collected in the study case report form. These patients will be re-evaluated in the inclusion visit 30 days later (T1); if SPPB score will be 0-3 or 10-12 the patients will be considered screening failure and they will be followed up exclusively with clinical visit every year; on the contrary, if SPPB score will be 4-9, patients will be randomized to standard of care group or experimental group. There will be a stratified randomization by: