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Recruiting NCT06908759

Risk of Falling and Cardiac Rehabilitation

Trial Parameters

Condition Risk of Falling
Sponsor IRCCS San Raffaele Roma
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2024-05-31
Completion 2025-05-30
Interventions
EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Brief Summary

Background and Rationale Cardiac rehabilitation (CR) is a key intervention for patients with chronic heart disease or recent acute cardiovascular events. In elderly and frail patients, CR aims not only to improve functional capacity but also to maintain or recover independence in daily activities. Hospitalization following an acute event often leads to bed rest, which-even after just 2-3 days-can cause hypokinetic syndrome, characterized by loss of muscle tone, orthostatic hypotension, decreased mobility, and psychological decline, including depression. Moreover, immobility increases thrombotic risk and vascular complications. To mitigate these effects, CR is initiated promptly after clinical stabilization and includes three phases: 1. Phase I - In-hospital rehabilitation 2. Phase II - Early outpatient rehabilitation 3. Phase III - Long-term maintenance Elderly patients are particularly vulnerable to falls due to the combined effects of reduced muscle strength, orthostatic hypotension, cognitive decline, and pre-existing sarcopenia-often exacerbated by acute events and immobility. Approximately 60% of cardiac patients hospitalized for acute events present with moderate-to-high fall risk. Fall risk in this population is multifactorial, involving cardiovascular issues (e.g., arrhythmias, orthostatic hypotension), medication effects, and non-cardiac factors such as vision loss, balance impairment, neuromuscular conditions, and cognitive deficits.

Eligibility Criteria

Inclusion Criteria: \- Age \> 65 years Recent acute cardiac event, including: 1. Cardiac surgery (CABG, aortic and/or mitral valve replacement, mitral valvuloplasty, or combined CABG + valve surgery) 2. Recent myocardial infarction treated with percutaneous revascularization 3. Episode of acute heart failure Exclusion Criteria: Persistent clinical instability, defined as: * Marked hypotension (BP ≤ 95/60 mmHg) or hypertension (BP ≥ 160/100 mmHg) * Bradycardia (HR \< 50 bpm) or tachycardia (HR \> 115 bpm) * Resting dyspnea * Signs and symptoms of infection

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