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Acute Sarcopenia in Hospitalized Older Adults

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07454759
Acronym
BASIS
Enrollment
280
Registered
2026-03-06
Start date
2026-06-01
Completion date
2027-05-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia, Sarcopenia in Elderly

Keywords

sarcopenia, acute sarcopenia

Brief summary

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

Interventions

DIAGNOSTIC_TESTAcute 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 post-discharge.

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER
Società Italiana di Medicina Interna
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
ACUTE SARCOPENIA INCIDENCETime 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).Primary Objective: to determine the incidence of acute sarcopenia, defined as a reduction in muscle mass and strength during hospitalization in older adults. Primary Endpoint: incidence of acute sarcopenia, defined as a reduction in muscle mass (BIA and anterior thigh ultrasound) and muscle strength (handgrip dynamometry) compared with baseline.

Secondary

MeasureTime frameDescription
ACUTE SARCOPENIA RISK FACTORS AND OUTCOMESTime 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.to identify clinical and demographic risk factors for acute sarcopenia, relevant clinical outcomes such as length of stay, nosocomial infections, pressure injuries, rehospitalization and mortality.

Contacts

CONTACTSarah Damanti, MD, PhD
damanti.sarah@hsr.it+390226436095
CONTACTAnna Fumagalli, MSc
fumagalli.anna@hsr.it+390226436095
PRINCIPAL_INVESTIGATORSarah Damanti, MD, PhD

IRCCS Ospedale San Raffaele

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026