University Federico II of Naples, Department of Public Health
Naples, Napoli, 80131, Italy
NCT Number: NCT07437690
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.
Trial opening soon.
Get Notified65 year–99 year
All sexes
Observational
Naples, Napoli, 80131, Italy
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)
All patients will undergo specific rehabilitation training for fall risk prevention and will be assessed twice at To and T1.
Time frame: 2 months
Participant balance assessed using standardized clinical tests.
Time frame: two months
Measured in degrees using goniometry
Time frame: two months
Total score 0-10; score >4 indicates probable sarcopenia.
Time frame: two months
Time in seconds maintaining balance.
Time frame: two months
Scale 0-10; 0 = no pain, 10 = worst pain.
Time frame: two months
Total score 0-12; lower scores indicate poorer physical performance.
Time frame: two months
17-item questionnaire; higher scores indicate better quality of life.
Contact information is provided by the study sponsor or research team.
Antonio Picone, PhD
CONTACT
Rossana Gnasso, Researcher
CONTACT
Federico II University
Other
FALL PREVENTION IN OLDER ADULT: OBSERVATIONAL PROSPECTIVE STUDY ON AN ITALIAN COHORT
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.
Published trials that share one or more normalized conditions with this study.
NCT07508527
Balance, Chemotherapy Induced Peripheral Neuropathy (CIPN)
View Trial DetailsNCT07380191
Fall Risk, Fall Prevention
Tanta, Alquarbia, Egypt
View Trial DetailsNCT06973460
Aged, Aged Healthy Volunteer
Ajman, United Arab Emirates
View Trial DetailsNCT07061106
Fall Risk, Fall Prevention
Rawalpindi, Pakistan
View Trial Details