Fall Prevention in Older Adults in an Italian Cohort

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Accidental Falls; Fall Risk, Fall Prevention; Fall Risk
• Intervention / Treatment: Device: Khymeia

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Rossana Gnasso, Researcher; Phone Number: +39 3935360702; Email: rossana.gnasso@unina.it
• Study Contact Backup: Name: Antonio Picone, PhD; Phone Number: +39 3398780254; Email: antonio.picone@unina.it

Study Locations

• Italy
  • Napoli
    • Napoli, Napoli, Italy, 80131
      • University Federico II of Naples, Department of Public Health
      • Contact: Rossana Gnasso, Researcher; Phone Number: 0817462870; Email: rossana.gnasso@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

elderly>65 years with higher fall risk

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
evaluation of strength and endurance training in patients with risk of falls and sarcopenia, assesse	Device: Khymeia; All patients will undergo specific rehabilitation training for fall risk prevention and will be assessed twice at To and T1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance Measurement	Participant balance assessed using standardized clinical tests.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint Range of Motion (Degrees)	Measured in degrees using goniometry	two months
SARC-F Score for Sarcopenia Screening	Total score 0-10; score >4 indicates probable sarcopenia.	two months
Romberg Test Balance Time (Seconds)	Time in seconds maintaining balance.	two months
Pain Intensity Measured by Numeric Rating Scale (0-10)	Scale 0-10; 0 = no pain, 10 = worst pain.	two months
Short Physical Performance Battery (SPPB) Total Score	Total score 0-12; lower scores indicate poorer physical performance.	two months
Quality of Life Scale (QOLS) Total Score	17-item questionnaire; higher scores indicate better quality of life.	two months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): August 20, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: elderly; accidental falls; sarcopenia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID Numbers: 127/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Study results will be disseminated through scientific publications and presentations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No