Actively Recruiting
Risk of Falling and Cardiac Rehabilitation
Led by IRCCS San Raffaele Roma · Updated on 2025-04-03
150
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Risk of Falling and Cardiac Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 65 years
- Recent cardiac surgery (CABG, valve replacement, valvuloplasty, or combined surgery)
- Recent myocardial infarction treated with percutaneous revascularization
- Recent episode of acute heart failure
You will not qualify if you...
- Persistent clinical instability including 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCs San Raffaele
Rome, RM, Italy, 00166
Actively Recruiting
Research Team
L
Lucia Gatta
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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