Risk of Falling and Cardiac Rehabilitation

NCT06908759 | Recruiting

• 1 other identifier: 119/SR/24
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.Phase I - In-hospital rehabilitation
2. 2.Phase II - Early outpatient rehabilitation
3. 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.

Conditions

Risk of Falling; Elderly (People Aged 65 or More); Cardiovascular Diseases

Keywords

risk of fall; cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

supervised exercise in cardiac rehabilitation

EXPERIMENTAL

group 1: patients will perform supervised exercise training in the gym of San Raffaele IRCCS of Rome

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

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

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

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

home-based exercise; supervised exercise in cardiac rehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCs San Raffaele

Rome, RM, 00166, Italy

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise; Dosage Forms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Lucia Gatta

CONTACT

+390652253440; lucia.gatta@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 3, 2025
• Study Start: May 31, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

IT (1)