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Fall Prevention in Older Adults in an Italian Cohort

FALL PREVENTION IN OLDER ADULT: OBSERVATIONAL PROSPECTIVE STUDY ON AN ITALIAN COHORT

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07437690
Enrollment
50
Registered
2026-02-27
Start date
2026-02-20
Completion date
2026-08-20
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls, Fall Risk, Fall Risk, Fall Prevention

Keywords

accidental falls, sarcopenia, elderly

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.

Interventions

DEVICEKhymeia

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

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 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)

Design outcomes

Primary

MeasureTime frameDescription
Balance Measurement2 monthsParticipant balance assessed using standardized clinical tests.

Secondary

MeasureTime frameDescription
Joint Range of Motion (Degrees)two monthsMeasured in degrees using goniometry
SARC-F Score for Sarcopenia Screeningtwo monthsTotal score 0-10; score \>4 indicates probable sarcopenia.
Romberg Test Balance Time (Seconds)two monthsTime in seconds maintaining balance.
Pain Intensity Measured by Numeric Rating Scale (0-10)two monthsScale 0-10; 0 = no pain, 10 = worst pain.
Short Physical Performance Battery (SPPB) Total Scoretwo monthsTotal score 0-12; lower scores indicate poorer physical performance.
Quality of Life Scale (QOLS) Total Scoretwo months17-item questionnaire; higher scores indicate better quality of life.

Countries

Italy

Contacts

CONTACTRossana Gnasso, Researcher
rossana.gnasso@unina.it+39 3935360702
CONTACTAntonio Picone, PhD
antonio.picone@unina.it+39 3398780254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026