Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT06908759

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCs San Raffaele

Rome, RM, Italy, 00166

Actively Recruiting

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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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