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NCT Number: NCT07454759

Acute Sarcopenia in Hospitalized Older Adults

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

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia in Elderly Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

ACUTE SARCOPENIA INCIDENCE

Time frame: 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).

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 outcomes

ACUTE SARCOPENIA RISK FACTORS AND OUTCOMES

Time frame: 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.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Fumagalli, MSc

CONTACT

[email protected]

+390226436095

Sarah Damanti, MD, PhD

CONTACT

[email protected]

+390226436095

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

Società Italiana di Medicina Interna

Registry information

Official study title

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

Acronym: BASIS

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Mar 6, 2026
Registry last updated: Mar 6, 2026

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.

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