NCT06908759 Risk of Falling and Cardiac Rehabilitation
| NCT ID | NCT06908759 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele Roma |
| Condition | Risk of Falling |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-05-31 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-05-31 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06908759 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Risk of Falling. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06908759 currently recruiting?
Yes, NCT06908759 is actively recruiting participants. Contact the research team at lucia.gatta@sanraffaele.it for enrollment information.
Where is the NCT06908759 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06908759 clinical trial?
NCT06908759 is sponsored by IRCCS San Raffaele Roma. The trial plans to enroll 150 participants.