Fall Prevention in Older Adults in an Italian Cohort

NCT07437690 | Not Yet Recruiting

• 1 other identifier: 127/2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fall Risk, Fall Prevention; Fall Risk; Accidental Falls

Keywords

accidental falls; sarcopenia; elderly

Outcome Measures

Primary Outcomes (1)

• Balance Measurement

  Participant balance assessed using standardized clinical tests.

  2 months

Secondary Outcomes (6)

• Joint Range of Motion (Degrees)

  two months

• SARC-F Score for Sarcopenia Screening

  two months

• Romberg Test Balance Time (Seconds)

  two months

• Pain Intensity Measured by Numeric Rating Scale (0-10)

  two months

• Short Physical Performance Battery (SPPB) Total Score

  two months

Study Arms (1)

evaluation of strength and endurance training in patients with risk of falls and sarcopenia, assesse

Device: Khymeia

Interventions

Khymeia DEVICE

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

evaluation of strength and endurance training in patients with risk of falls and sarcopenia, assesse

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

elderly\>65 years with higher fall risk

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)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University Federico II of Naples, Department of Public Health

Naples, Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Rossana Gnasso, Researcher

CONTACT

+39 3935360702; rossana.gnasso@unina.it

Antonio Picone, PhD

CONTACT

+39 3398780254; antonio.picone@unina.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 27, 2026
• Study Start: February 20, 2026
• Primary Completion: April 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)