Acute Sarcopenia in Hospitalized Older Adults (BASIS)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia; Sarcopenia in Elderly
• Intervention / Treatment: Diagnostic test: 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

• Study Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Sarah Damanti, MD, PhD; Phone Number: +390226436095; Email: damanti.sarah@hsr.it
• Study Contact Backup: Name: Anna Fumagalli, MSc; Phone Number: +390226436095; Email: fumagalli.anna@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

hospitalized older people

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Groups: older adults aged 65 years or above, hospitalized for acute medical condition; Groups: older adults (male and female) aged 65 years or above, hospitalized for acute medical conditions.

Diagnostic test: 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 post-discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACUTE SARCOPENIA INCIDENCE	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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACUTE SARCOPENIA RISK FACTORS AND OUTCOMES	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.	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.

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Collaborators: Società Italiana di Medicina Interna
• Investigators: Principal Investigator: Sarah Damanti, MD, PhD, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: sarcopenia; acute sarcopenia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID Numbers: BASIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No