Risk of Falling Assessment in a Population of Patients With Cardiovascular Diseases Undergoing Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To evaluate the effect of cardiac rehabilitation on the risk of falling in elderly cardiac patients following a recent acute event requiring hospitalization.
研究概览
简要总结
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:
- Phase I - In-hospital rehabilitation
- Phase II - Early outpatient rehabilitation
- 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.
详细描述
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:
- Phase I rehabilitation (in-hospital)
- Phase II rehabilitation (early outpatient)
- Phase III rehabilitation (maintenance phase) [1]. Loss of muscle mass and tone, orthostatic hypotension, and cognitive impairments all contribute to an increased fall risk in the elderly. It is estimated that approximately 60% of heart disease patients hospitalized for an acute event have a medium-to-high fall risk [2,3].
Specifically in cardiac patients, multiple additional factors may contribute to fall risk in this population, including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
supervised exercise in cardiac rehabilitation
group 1: patients will perform supervised exercise training in the gym of San Raffaele IRCCS of Rome
干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Other)
home-based exercise
group 1: patients will be asked to perform not supervised exercise training at home according to european guidelines for people with cardiovascular diseases
干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Other)
结局指标
主要结局
To evaluate the effect of cardiac rehabilitation on the risk of falling in elderly cardiac patients following a recent acute event requiring hospitalization.
时间窗: Fron enrollment to the end of the in-hospital phase and after 12 weeks from discharge
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
次要结局
未报告次要终点