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Clinical Trials in Italy / NCT06908759
Recruiting Not applicable

Risk of Falling and Cardiac Rehabilitation

NCT06908759 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-05-31
Last updated
2025-04-03

Condition(s) studied

Risk of FallingElderly (People Aged 65 or More)Cardiovascular Diseases

Investigational drug(s) / intervention(s)

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

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

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCs San Raffaele Rome RM Recruiting

More IRCCS San Raffaele Roma trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06908759 on ClinicalTrials.gov ↗ ← All trials in Italy