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Clinical Trials in Italy / NCT07437690
Starting soon Observational

Fall Prevention in Older Adults in an Italian Cohort

NCT07437690 · tracked via the Priya Life Science Italy tracker
Sponsor
Federico II University
Phase
Observational
Started
2026-02-20
Last updated
2026-02-27

Condition(s) studied

Fall Risk, Fall PreventionFall RiskAccidental Falls

Investigational drug(s) / intervention(s)

Khymeia

Khymeia: All patients will undergo specific rehabilitation training for fall risk prevention and will be assessed twice at To and T1.

Study 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. 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
99 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Balance Measurement — 2 months
    Participant balance assessed using standardized clinical tests.

Trial sites (1)

FacilityCityRegionStatus
University Federico II of Naples, Department of Public Health Naples Napoli

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07437690 on ClinicalTrials.gov ↗ ← All trials in Italy