Risk of FallingCARDIO-BALANCENCT06908759
Risk of Falling and Cardiac Rehabilitation
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Risk of Falling and Elderly (People Aged 65 or More), run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Risk of Falling, Elderly (People Aged 65 or More), Cardiovascular Diseases
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCs San Raffaele
Rome, RM, 00166
Prof. Giuseppe Caminiti, MD, 0652253440, giuseppe.caminitii@sanraffaele.it
About this study
Official title: Risk of Falling Assessment in a Population of Patients With Cardiovascular Diseases Undergoing Cardiac Rehabilitation
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.
Read the detailed description
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:
- 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:
- Tachyarrhythmias or bradyarrhythmias (sustained ventricular tachycardia; severe bradycardia; advanced sinoatrial or atrioventricular block).
- Orthostatic hypotension: Often caused by autonomic dysfunction related to prolonged bed rest and/or use of blood pressure-lowering medications such as vasodilators. Excessive reduction in blood volume from diuretics can also contribute.
- Non-cardiac conditions:
- Cardiac patients, especially older ones, may have reduced vision, balance disorders, cognitive impairments, or neuromuscular disorders that make walking unstable.
- Additionally, elderly cardiac patients-particularly those with heart failure-have a high prevalence of sarcopenia. This condition, often present at baseline, may be significantly worsened by the acute clinical event and resulting hypo-/immobility.
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.
- We hypothesize that patients completing a supervised rehabilitation cycle will score better on the Conley Scale than those discharged directly home.
- Secondary endpoints include:
- Effects of rehabilitation on balance in elderly cardiac patients
- Effects of rehabilitation on sleep quality, anxiety, and stress levels
- The impact of rehabilitation will also be evaluated based on hospital stay duration and total volume of physical training performed
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Keywords
- risk of fall, cardiac rehabilitation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther
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
| Study group | Role | What they receive |
|---|---|---|
| supervised exercise in cardiac rehabilitation | Experimental | group 1: patients will perform supervised exercise training in the gym of San Raffaele IRCCS of Rome Receives: 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 Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Fron enrollment to the end of the in-hospital phase and after 12 weeks from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start31 May 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of FallingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908759
- Sponsor's protocol ID
- 119/SR/24
- Acronym
- CARDIO-BALANCE
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Falling Assessment in a Population of Patients With Cardiovascular Diseases Undergoing Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT06908759
- Acronym / sponsor ID
- CARDIO-BALANCE / 119/SR/24
- Keywords
- risk of fall, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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:
- Tachyarrhythmias or bradyarrhythmias (sustained ventricular tachycardia; severe bradycardia; advanced sinoatrial or atrioventricular block).
- Orthostatic hypotension: Often caused by autonomic dysfunction related to prolonged bed rest and/or use of blood pressure-lowering medications such as vasodilators. Excessive reduction in blood volume from diuretics can also contribute.
- Non-cardiac conditions:
- Cardiac patients, especially older ones, may have reduced vision, balance disorders, cognitive impairments, or neuromuscular disorders that make walking unstable.
- Additionally, elderly cardiac patients-particularly those with heart failure-have a high prevalence of sarcopenia. This condition, often present at baseline, may be significantly worsened by the acute clinical event and resulting hypo-/immobility.
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.
- We hypothesize that patients completing a supervised rehabilitation cycle will score better on the Conley Scale than those discharged directly home.
- Secondary endpoints include:
- Effects of rehabilitation on balance in elderly cardiac patients
- Effects of rehabilitation on sleep quality, anxiety, and stress levels
- The impact of rehabilitation will also be evaluated based on hospital stay duration and total volume of physical training performed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| supervised exercise in cardiac rehabilitation | Experimental | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONgroup 1: patients will perform supervised exercise training in the gym of San Raffaele IRCCS of Rome |
| home-based exercise | Active comparator | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONgroup 1: patients will be asked to perform not supervised exercise training at home according to european guidelines for people with cardiovascular diseases |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age > 65 years
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONIn 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 | Other | home-based exercise, supervised exercise in cardiac rehabilitation |
Primary outcome
To evaluate the effect of cardiac rehabilitation on the risk of falling in elderly cardiac patients following a recent acute event requiring hospitalization.
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Risk of Falling and Elderly (People Aged 65 or More), run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucia Gatta (+390652253440, lucia.gatta@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of cardiac rehabilitation on the risk of falling in elderly cardiac patients following a recent acute event requiring hospitalization. (time frame: Fron enrollment to the end of the in-hospital phase and after 12 weeks from discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.