Fall Prevention in Older Adults in an Italian Cohort

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Conditions studied: Fall Risk, Fall Prevention, Fall Risk, Accidental Falls

In brief

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.

Key facts

Study ID

NCT07437690

Run by

Federico II University

People needed

50

Starts

2026-02-20

Expected to finish

2026-08-20

Last updated by the study team

2026-02-27

Who can join

Age: 65 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University Federico II of Naples, Department of Public Health — Naples, Napoli, Italy

Full record on ClinicalTrials.gov

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