Fall Prevention in Older Adults in an Italian Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Khymeia.
- Who it may be relevant to
- Registry conditions: Fall Risk, Fall Prevention, Fall Risk, Accidental Falls. Basic parameters: 65 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
FALL PREVENTION IN OLDER ADULT: OBSERVATIONAL PROSPECTIVE STUDY ON AN ITALIAN COHORT
Overview
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.
Interventions
- Device Khymeia
All patients will undergo specific rehabilitation training for fall risk prevention and will be assessed twice at To and T1.
Primary outcome measures
- Balance Measurement [Time frame: 2 months]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University Federico II of Naples, Department of Public Health — Naples
Identifiers
NCT: NCT07437690 · 127/2025