Please select the arm or intervention descriptions that belong 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: Arm Label: Attention Control Group (AC); Type: ACTIVE_COMPARATOR; Interventions: Other: Mediterranean Diet Recommendations, Other: Physical Activity Recommendations | Arm Label: HV-HIIT; Type: EXPERIMENTAL; Interventions: Other: HIGH VOLUME (HV) Supervised exercise, Other: Mediterranean Diet Recommendations | Arm Label: LV-HIIT; Type: EXPERIMENTAL; Interventions: Other: Mediterranean Diet Recommendations, Other: LOW VOLUME (LW) Supervised exercise | Intervention Type: OTHER; Name: HIGH VOLUME (HV) Supervised exercise; Assigned to Arm(s): HV-HIIT | Intervention Type: OTHER; Name: Mediterranean Diet Recommendations; Assigned to Arm(s): Attention Control Group (AC), HV-HIIT, LV-HIIT | Intervention Type: OTHER; Name: Physical Activity Recommendations; Assigned to Arm(s): Attention Control Group (AC) | Intervention Type: OTHER; Name: LOW VOLUME (LW) Supervised exercise; Assigned to Arm(s): LV-HIIT
B: Arm Label: STANDARD OF CARE; Type: OTHER; Interventions: Other: standard of care | Arm Label: PHYSICAL ACTIVITY INTERVENTION; Type: EXPERIMENTAL; Interventions: Other: physical activity intervention | Intervention Type: OTHER; Name: physical activity intervention; Assigned to Arm(s): PHYSICAL ACTIVITY INTERVENTION | Intervention Type: OTHER; Name: standard of care; Assigned to Arm(s): STANDARD OF CARE
C: Arm Label: PATHway; Type: EXPERIMENTAL; Interventions: Behavioral: PATHway | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: PATHway; Assigned to Arm(s): PATHway
D: Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Prehab Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Prehab Intervention | Intervention Type: BEHAVIORAL; Name: Prehab Intervention; Assigned to Arm(s): Prehab Intervention

Answer: B