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RECRUITING
NCT06908759
NA

Risk of Falling and Cardiac Rehabilitation

Sponsor: IRCCS San Raffaele Roma

View on ClinicalTrials.gov

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.

Official title: Risk of Falling Assessment in a Population of Patients With Cardiovascular Diseases Undergoing Cardiac Rehabilitation

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-05-31

Completion Date

2025-06-30

Last Updated

2025-04-03

Healthy Volunteers

No

Interventions

OTHER

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

In the first phase of the study all enrolled patients will perform exercise in the context of an in-hospital intesive rehabilitation after the acute event. At discharge they will be randomized in two groups: supervised exercise in the context of a cardiac rehabilitation facility or home-based exercise

Locations (1)

IRCCs San Raffaele

Rome, RM, Italy