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NCT Number: NCT07437690

Fall Prevention in Older Adults in 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.

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Key information

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Federico II of Naples, Department of Public Health

Naples, Napoli, 80131, Italy

Location contact

Rossana Gnasso, Researcher

CONTACT

[email protected]

0817462870

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Khymeia

Device

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

Primary outcomes

  1. Balance Measurement

    Time frame: 2 months

    Participant balance assessed using standardized clinical tests.

Secondary outcomes

  1. Joint Range of Motion (Degrees)

    Time frame: two months

    Measured in degrees using goniometry

  2. SARC-F Score for Sarcopenia Screening

    Time frame: two months

    Total score 0-10; score >4 indicates probable sarcopenia.

  3. Romberg Test Balance Time (Seconds)

    Time frame: two months

    Time in seconds maintaining balance.

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

    Time frame: two months

    Scale 0-10; 0 = no pain, 10 = worst pain.

  5. Short Physical Performance Battery (SPPB) Total Score

    Time frame: two months

    Total score 0-12; lower scores indicate poorer physical performance.

  6. Quality of Life Scale (QOLS) Total Score

    Time frame: two months

    17-item questionnaire; higher scores indicate better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Picone, PhD

CONTACT

[email protected]

+39 3398780254

Rossana Gnasso, Researcher

CONTACT

[email protected]

+39 3935360702

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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