Please select the eligibility criteria that correspond to the clinical trial below.
Title: Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome: a Randomized Clinical Trial (The HULK Pilot Study).
Brief Summary: 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.

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.


Options:
A: Inclusion Criteria:

* Two months to 10 years from the cardiovascular event.
* Left ventricular ejection fraction \> 30%
* Ability to undertake regular physical activity (walking and biking)

Exclusion Criteria:

* Moderate to severe heart valvular disease.
* Atrial fibrilation.
* Uncontrolled atrial or ventricular arrhythmias.
* Exercise induced myocardial ischaemia.
* Pericardial disease.
* Uncontrolled hypertension.
* Insulin dependent diabetes mellitus.
* Moderate to severe chronic lung disease (Vital capacity and/or forced expiratory volume during the first second \<80% to that expected for the age).
* Severe kidney disease (renal creatinine clearance \<30 mL/min, calculated by Cockcroft-Gault formula).
* Anaemia (haemoglobin \<12 g/dL).
* Life expectancy less than one year.
B: Inclusion Criteria:

* informed consent
* age ≥70 years old
* hospital admission for acute coronary syndrome
* coronary artery angiography and successfully percutaneous coronary revascularization
* result of the short physical performance battery test at the inclusion visit between 4 and 9

Exclusion Criteria:

* chronic heart failure (new york heart association classification III-IV)
* left ventricle ejection fraction \<30%.
* severe aortic or mitral valvulopathy
* three vessel coronary artery disease or left main coronary artery disease requiring surgical coronary revascularization
* need of staged percutaneous coronary intervention
* severe cognitive impairment (defined as short portable mental status questionnaire \< 4)
* physical limitation/impairment not permitting physical activity training annd program
* life expectancy \<12 months
C: Inclusion Criteria:

* Men and women with documented CVD
* age 40-80 yrs
* patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
* patients must have completed the ambulatory CR program and received clinical approval from their treating physician to continue exercising outside the hospital program
* internet access at home

Exclusion Criteria:

* significant illness during the last 6 weeks
* known severe ventricular arrhythmia with functional or prognostic significance
* significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
* cardiac disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
* co-morbidity that may significantly influence one-year prognosis
* functional or mental disability that may limit exercise
* acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
* GFR \<25ml/min/1.73m2
* hemoglobin \< 10g/dl
* severe chronic obstructive pulmonary disease (FEV1 \< 50%)
* NYHA class 4
* participation in another clinical trial
D: Inclusion Criteria:

* Patients aged 60 years and older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair/replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures
* Patients with Clinical Frailty Score (CFS) ≥3 (vulnerable) and \< 7 (8 = very severely frail, approaching end-of-life or 9 = terminally ill) at time of acceptance for cardiac surgery
* Patients with an estimated ≥ 6 week wait time

Exclusion Criteria:

* Patients who have unstable or recent unstable cardiac syndrome as defined by:

  1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms
  2. Critical left main (LM) coronary disease
  3. Hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome prior to randomization
* Patients who have severe left ventricular obstructive disease as defined by:

  1. Severe aortic or mitral stenosis (aortic or mitral valve area \<1.0cm2 or mean gradient \> 40 mmHg or \> 10 mmHg respectively)
  2. Dynamic left ventricular (LV) outflow obstruction
* Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias
* Patients who have cognitive deficits that would preclude rehabilitation
* Patients who have physical limitations that would preclude rehabilitation
* Patients who are unable to attend the Prehab program

Answer: B