RecruitingNot ApplicableNCT06908759

Risk of Falling and Cardiac Rehabilitation

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


Sponsor

IRCCS San Raffaele Roma

Enrollment

150 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria5

  • \- Age \> 65 years
  • Recent acute cardiac event, including:
  • Cardiac surgery (CABG, aortic and/or mitral valve replacement, mitral valvuloplasty, or combined CABG + valve surgery)
  • Recent myocardial infarction treated with percutaneous revascularization
  • Episode of acute heart failure

Exclusion Criteria5

  • 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

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Interventions

OTHEREXERCISE 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

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NCT06908759


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