Fall Risk, Fall PreventionNCT07437690
Fall Prevention in Older Adults in an Italian Cohort
An observational study of Fall Risk, Fall Prevention and Fall Risk, run by Federico II University at 1 site in Italy.
Trial summary
Proximal femoral fractures are associated with increased mortality in older adults and may contribute to loss of functional independence, resulting in a higher risk of long-term institutionalization. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Fall Risk, Fall Prevention, Fall Risk, Accidental Falls
- What is being tested?
- Khymeia
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2026to 20 Aug 2026
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly>65 years with higher fall risk
Who may be able to join
- Age ≥ 65 years at the time of enrollment
- Radiographically confirmed knee osteoarthritis or hip osteoarthritis classified as Kellgren-Lawrence grade 2 or 3
- Clinical indication for structured rehabilitation therapy
- Diagnosis of sarcopenia according to European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria, defined as:
- Low muscle strength (handgrip strength < 27 kg in men or < 16 kg in women, or chair stand test > 15 seconds for 5 rises), and
- Reduced muscle mass confirmed by a validated assessment method (e.g., dual-energy X-ray absorptiometry [DXA] or bioelectrical impedance analysis [BIA]) according to established cut-off values
Who cannot join
- Absolute contraindication to rehabilitation therapy as determined by the treating physician
- Hemodynamic instability, including uncontrolled arrhythmias, symptomatic hypotension, or acute coronary syndrome within the previous 3 months
- Unstable fractures
- Severe open wounds or lacerated-contused injuries requiring surgical management
- Severe cognitive impairment preventing participation in rehabilitation activities (e.g., Mini-Mental State Examination score < 18)
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
University Federico II of Naples, Department of Public Health
Naples, Napoli, 80131
Rossana Gnasso, Researcher, 0817462870, rossana.gnasso@unina.it
About this study
Official title: FALL PREVENTION IN OLDER ADULT: OBSERVATIONAL PROSPECTIVE STUDY ON AN ITALIAN COHORT
Proximal femoral fractures are associated with increased mortality in older adults and may contribute to loss of functional independence, resulting in a higher risk of long-term institutionalization. The SIOT 2021 guidelines emphasize that management of older patients with proximal femoral fracture (FPF) requires a multidisciplinary approach, ideally integrated across all phases of care, including rehabilitation and secondary prevention at the community level, according to a continuity-of-care model that incorporates the implementation of Fracture Liaison Services.
Multiple clinical, social, and environmental factors influence fall risk. Falls are also associated with psychological consequences. Age-related reductions in muscle strength contribute to progressive functional decline, increased morbidity and mortality related to falls, reduced quality of life, depression, and hospitalization.
Read more
Sarcopenia is characterized by both quantitative and qualitative reductions in muscle tissue, including progressive replacement of contractile tissue with fibrous and adipose tissue. The European Working Group on Sarcopenia in Older People (EWGSOP), in its updated consensus (EWGSOP2), identifies low muscle strength as the primary parameter of sarcopenia, accompanied by a significant and generalized reduction in muscle mass.
A use-case model dedicated to patients with sarcopenia describes typical demographic and social characteristics, associated comorbidities, and specific care needs, with the aim of identifying the most appropriate management pathways.
This study adopts a person-centered approach to design, validate, and implement an integrated strategy for fall prevention, taking into account the multiple determinants of fall risk and related adverse health outcomes.
- Conditions
- Fall Risk, Fall Prevention, Fall Risk, Accidental Falls
- Being tested
- Khymeia
- Keywords
- accidental falls, sarcopenia, elderly
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KhymeiaDevice
All patients will undergo specific rehabilitation training for fall risk prevention and will be assessed twice at To and T1.
| Study group | Role | What they receive |
|---|---|---|
| evaluation of strength and endurance training in patients with risk of falls and sarcopenia, assesse | Not described Receives: Device: Khymeia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Measurement
Participant balance assessed using standardized clinical tests.
Measured: 2 months
Secondary outcomes (6)
Joint Range of Motion (Degrees)
Measured in degrees using goniometry
Measured: two months
SARC-F Score for Sarcopenia Screening
Total score 0-10; score >4 indicates probable sarcopenia.
Measured: two months
Romberg Test Balance Time (Seconds)
Time in seconds maintaining balance.
Measured: two months
Pain Intensity Measured by Numeric Rating Scale (0-10)
Scale 0-10; 0 = no pain, 10 = worst pain.
Measured: two months
Short Physical Performance Battery (SPPB) Total Score
Total score 0-12; lower scores indicate poorer physical performance.
Measured: two months
Quality of Life Scale (QOLS) Total Score
17-item questionnaire; higher scores indicate better quality of life.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Risk, Fall PreventionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossana Gnasso, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437690
- Sponsor's protocol ID
- 127/2025
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study results will be disseminated through scientific publications and presentations
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FALL PREVENTION IN OLDER ADULT: OBSERVATIONAL PROSPECTIVE STUDY ON AN ITALIAN COHORT
- ClinicalTrials.gov ID
- NCT07437690
- Acronym / sponsor ID
- 127/2025
- Conditions
- Fall Risk, Fall Prevention, Fall Risk, Accidental Falls
- Keywords
- accidental falls, sarcopenia, elderly
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
Proximal femoral fractures are associated with increased mortality in older adults and may contribute to loss of functional independence, resulting in a higher risk of long-term institutionalization. The SIOT 2021 guidelines emphasize that management of older patients with proximal femoral fracture (FPF) requires a multidisciplinary approach, ideally integrated across all phases of care, including rehabilitation and secondary prevention at the community level, according to a continuity-of-care model that incorporates the implementation of Fracture Liaison Services.
Multiple clinical, social, and environmental factors influence fall risk. Falls are also associated with psychological consequences. Age-related reductions in muscle strength contribute to progressive functional decline, increased morbidity and mortality related to falls, reduced quality of life, depression, and hospitalization.
Sarcopenia is characterized by both quantitative and qualitative reductions in muscle tissue, including progressive replacement of contractile tissue with fibrous and adipose tissue. The European Working Group on Sarcopenia in Older People (EWGSOP), in its updated consensus (EWGSOP2), identifies low muscle strength as the primary parameter of sarcopenia, accompanied by a significant and generalized reduction in muscle mass.
A use-case model dedicated to patients with sarcopenia describes typical demographic and social characteristics, associated comorbidities, and specific care needs, with the aim of identifying the most appropriate management pathways.
This study adopts a person-centered approach to design, validate, and implement an integrated strategy for fall prevention, taking into account the multiple determinants of fall risk and related adverse health outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| evaluation of strength and endurance training in patients with risk of falls and sarcopenia, assesse | – | Device: Khymeia |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly>65 years with higher fall risk
Key inclusion criteria (6 listed)
- Age ≥ 65 years at the time of enrollment
- Radiographically confirmed knee osteoarthritis or hip osteoarthritis classified as Kellgren-Lawrence grade 2 or 3
- Clinical indication for structured rehabilitation therapy
- Diagnosis of sarcopenia according to European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria, defined as:
- Low muscle strength (handgrip strength < 27 kg in men or < 16 kg in women, or chair stand test > 15 seconds for 5 rises), and
Key exclusion criteria (5 listed)
- Absolute contraindication to rehabilitation therapy as determined by the treating physician
- Hemodynamic instability, including uncontrolled arrhythmias, symptomatic hypotension, or acute coronary syndrome within the previous 3 months
- Unstable fractures
- Severe open wounds or lacerated-contused injuries requiring surgical management
- Severe cognitive impairment preventing participation in rehabilitation activities (e.g., Mini-Mental State Examination score < 18)
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 |
|---|---|---|
| KhymeiaAll patients will undergo specific rehabilitation training for fall risk prevention and will be assessed twice at To and T1. | Device | evaluation of strength and endurance training in patients with risk of falls and sarcopenia, assesse |
Primary outcome
Balance Measurement
Time frame: 2 months
Participant balance assessed using standardized clinical tests.
6 secondary outcomes
Joint Range of Motion (Degrees)
Time frame: two months
SARC-F Score for Sarcopenia Screening
Time frame: two months
Romberg Test Balance Time (Seconds)
Time frame: two months
Pain Intensity Measured by Numeric Rating Scale (0-10)
Time frame: two months
Short Physical Performance Battery (SPPB) Total Score
Time frame: two months
Quality of Life Scale (QOLS) Total Score
Time frame: two months
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 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study results will be disseminated through scientific publications and presentations
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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?
An observational study of Fall Risk, Fall Prevention and Fall Risk, run by Federico II University 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 6 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: opening soon, as of the sponsor's last update on 27 Feb 2026. 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 Rossana Gnasso, Researcher (+39 3935360702, rossana.gnasso@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Measurement (time frame: 2 months). 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 27 Feb 2026.