Меню
Набор скоро начнётся NCT07437690

Fall Prevention in Older Adults in an Italian Cohort

— Наблюдательное Fall Risk, Fall Prevention Fall Risk Accidental Falls

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Khymeia.
Кому может быть актуально
Состояния в реестре: Fall Risk, Fall Prevention, Fall Risk, Accidental Falls. Базовые параметры: 65 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

  • Balance Measurement [Срок оценки: 2 months]
Вторичные конечные точки (6)
  • Joint Range of Motion (Degrees) [Срок оценки: two months]
  • SARC-F Score for Sarcopenia Screening [Срок оценки: two months]
  • Romberg Test Balance Time (Seconds) [Срок оценки: two months]
  • Pain Intensity Measured by Numeric Rating Scale (0-10) [Срок оценки: two months]
  • Short Physical Performance Battery (SPPB) Total Score [Срок оценки: two months]
  • Quality of Life Scale (QOLS) Total Score [Срок оценки: two months]

Критерии участия

Критерии включения

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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • University Federico II of Naples, Department of Public Health — Naples

Идентификаторы

NCT: NCT07437690 · 127/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗