Acute Sarcopenia in Hospitalized Older Adults

NCT07454759 | Not Yet Recruiting

• 1 other identifier: BASIS
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sarcopenia; Sarcopenia in Elderly

Keywords

sarcopenia; acute sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ACUTE SARCOPENIA RISK FACTORS AND OUTCOMES

  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.

Study Arms (1)

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

Interventions

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.

Groups: older adults aged 65 years or above, hospitalized for acute medical condition

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospitalized older people

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Società Italiana di Medicina Interna: collaborator

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Sarah Damanti, MD, PhD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Damanti, MD, PhD

CONTACT

+390226436095; damanti.sarah@hsr.it

Anna Fumagalli, MSc

CONTACT

+390226436095; fumagalli.anna@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 6, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share