Fall Prevention in Older Adults in an Italian Cohort

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-99
SponsorFederico II University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

elderly\>65 years with higher fall risk

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Khymeia

    Device

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: evaluation of strength and endurance training in patients with risk of falls and sarcopenia, assesse1 intervention

Trial outcomes

Primary outcomes

1

Balance Measurement

Participant balance assessed using standardized clinical tests.

Time frame
2 months

Secondary outcomes

1

Joint Range of Motion (Degrees)

Measured in degrees using goniometry

Time frame
two months
2

SARC-F Score for Sarcopenia Screening

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

Time frame
two months
3

Romberg Test Balance Time (Seconds)

Time in seconds maintaining balance.

Time frame
two months
4

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

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

Time frame
two months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: