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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:
Cardiac rehabilitation is recommended for patients with chronic heart diseases and those who have experienced a recent acute cardiovascular event. Among the main goals of cardiac rehabilitation following an acute event is the recovery of functional capacity or, alternatively-especially in elderly and frail individuals-the maintenance or recovery of autonomy, at least in activities of daily living, within the limits imposed by the cardiac impairment.
An acute cardiovascular event requiring hospitalization is often accompanied by a period of varying duration of immobility and bed rest. Bed rest lasting more than 2-3 days may lead to a hypokinetic syndrome characterized by reduced or absent movement autonomy, loss of muscle tone, orthostatic hypotension (deconditioning), and often a decline in mood that may progress to depression. Furthermore, immobility is associated with increased thrombotic risk and consequently a greater chance of vascular complications.
To counteract bed rest and its complications, cardiac rehabilitation is initiated as soon as the patient's condition stabilizes and includes three phases:
Specifically in cardiac patients, multiple additional factors may contribute to fall risk in this population, including:
Cardiovascular conditions:
These may cause sudden reductions in cardiac output and/or inadequate increases in peripheral resistance, resulting in pre-syncope or syncope.
These include:
Non-cardiac conditions:
Study Objectives
Primary objective: To evaluate the effect of cardiac rehabilitation on fall risk in elderly cardiac patients following a recent acute event requiring hospitalization.
o We hypothesize that patients completing a supervised rehabilitation cycle will score better on the Conley Scale than those discharged directly home.
Secondary endpoints include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supervised exercise in cardiac rehabilitation | Experimental | group 1: patients will perform supervised exercise training in the gym of San Raffaele IRCCS of Rome |
|
| home-based exercise | Active Comparator | group 1: patients will be asked to perform not supervised exercise training at home according to european guidelines for people with cardiovascular diseases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of cardiac rehabilitation on the risk of falling in elderly cardiac patients following a recent acute event requiring hospitalization. | The risk of falling will be assessed through the Conley scale. We will consider the percentage changes in the score obtained in the Conley scale at different evaluation times in relation to the study design | Fron enrollment to the end of the in-hospital phase and after 12 weeks from discharge |
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Inclusion Criteria:
- Age > 65 years
Recent acute cardiac event, including:
Exclusion Criteria:
Persistent clinical instability, defined as:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Gatta | Contact | +390652253440 | lucia.gatta@sanraffaele.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCs San Raffaele | Recruiting | Rome | RM | 00166 | Italy |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The study will enroll 150 patients of both sexes with known cardiac disease, referred to the cardiac rehabilitation unit of IRCCS San Raffaele of Rome following an acute cardiac event requiring hospitalization.
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| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |