SarcopeniaBASISNCT07454759
Acute Sarcopenia in Hospitalized Older Adults
An observational study of Sarcopenia and Sarcopenia in Elderly, run by IRCCS San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Sarcopenia in Elderly
- What is being tested?
- 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
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: hospitalized older people
Who may be able to join
- Patients aged 65 years or older.
- Hospital admission for an acute medical condition
Who cannot join
- Presence of pre-existing neuromuscular disorders.
- Diagnosis of terminal illness with life expectancy less than 30 days
- Refuse to sign written informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- 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
- Keywords
- sarcopenia, acute sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) criteriaDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Società Italiana di Medicina Interna
- Responsible party
- Principal investigator, Sarah Damanti, IRCCS San Raffaele
- Investigators
- Sarah Damanti, MD, PhD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454759
- Sponsor's protocol ID
- BASIS
- Acronym
- BASIS
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Better Detection of Acute Sarcopenia in Hospitalized Older Adults: Integrating Clinical and Ultrasound Approaches
- ClinicalTrials.gov ID
- NCT07454759
- Acronym / sponsor ID
- BASIS / BASIS
- Conditions
- Sarcopenia, Sarcopenia in Elderly
- Keywords
- sarcopenia, acute sarcopenia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Società Italiana di Medicina Interna
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Groups: older adults aged 65 years or above, hospitalized for acute medical condition | – | 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) criteriaGroups: older adults (male and female) aged 65 years or above, hospitalized for acute medical conditions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- hospitalized older people
Key inclusion criteria (2 listed)
- Patients aged 65 years or older.
- Hospital admission for an acute medical condition
Key exclusion criteria (3 listed)
- Presence of pre-existing neuromuscular disorders.
- Diagnosis of terminal illness with life expectancy less than 30 days
- Refuse to sign written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) criteriaThe 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. | Diagnostic test | Groups: older adults aged 65 years or above, hospitalized for acute medical condition |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Damanti, MD, PhD principal investigator
IRCCS Ospedale San Raffaele
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Sarcopenia in Elderly, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Damanti, MD, PhD (+390226436095, damanti.sarah@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.