Acute Sarcopenia in Hospitalized Older Adults

Официальное название

Towards Better Detection of Acute Sarcopenia in Hospitalized Older Adults: Integrating Clinical and Ultrasound Approaches

Обзор

Acute sarcopenia is a rapid decline in muscle mass and function occurring within 28 days of a major stressor, such as hospitalization, infection, or surgery. It is frequent but often underdiagnosed in older adult. Current standard of care lacks systematic strategies for its early detection and risk stratification. This study therefore proposes to combine established clinical and instrumental assessments (handgrip dynamometry, bioelectrical impedance analysis, ultrasound of the anterior thigh) to better characterize the risk factors, and outcomes of acute sarcopenia in hospitalized patients aged 65 years or older. The study hypothesis is that the use of a systematic objective clinical assessments will improve early detection and risk stratification of this condition and the detection of acute sarcopenia related outcomes. This is a prospective observational cohort study that will be conducted in the Emergency Department and Medical Wards of the San Raffaele Hospital. Studies objectives will include: * Determination of the incidence of acute sarcopenia * Identification of clinical and demographic risk factors for acute sarcopenia and relevant clinical outcomes associated with this condition

Вмешательства

• Диагностический тест Acute sarcopenia will be defined as the incidence of sarcopenia compared to baseline measurements at recruitment, using the European Working Group on Sarcopenia in older people 2 (EWGSOP2) criteria
  The study procedures include: * Handgrip dynamometry to evaluate muscle strength using a standardized dynamometer. * Bioelectrical impedance analysis (BIA) and ultrasound of the anterior thigh to measure muscle mass. No comparator procedure is foreseen. The regimen includes baseline assessment within 24 hours of admission, repeated evaluations on days 3, 5, 7, 10, and every five days until discharge (on average maximum 20 days after hospital admission), with follow-up visits at 3 and 6 months

Первичные конечные точки

• ACUTE SARCOPENIA INCIDENCE [Срок оценки: Time point(s): baseline (within 24h of admission), days 3, 5, 7, 10, then every 5 days until hospital discharge (on average maximum 20 days after hospital admission).]

Вторичные конечные точки (1)

• ACUTE SARCOPENIA RISK FACTORS AND OUTCOMES [Срок оценки: Time point(s): baseline (within 24h of admission), days 3, 5, 7, 10, every 5 days until hospital discharge (on average maximum 20 days after hospital admission), and follow-ups at 3 and 6 months.]

Критерии участия

Критерии включения

• Patients aged 65 years or older.
• Hospital admission for an acute medical condition

Критерии исключения

• Presence of pre-existing neuromuscular disorders.
• Diagnosis of terminal illness with life expectancy less than 30 days
• Refuse to sign written informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07454759 · BASIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗