Acute Sarcopenia in Hospitalized Older Adults
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorIRCCS San Raffaele
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 65 years or older.
Hospital admission for an acute medical condition
Disqualifiers
Presence of pre-existing neuromuscular disorders.
Diagnosis of terminal illness with life expectancy less than 30 days
Refuse to sign written informed consent
Trial population
hospitalized older people
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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 testThe 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.
Treatment groups
280 Participants
are divided into 1 treatment groupGroup A: Groups: older adults aged 65 years or above, hospitalized for acute medical condition1 intervention
Trial outcomes
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 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).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.
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.Locations
Sponsors and contacts
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IRCCS San Raffaele
Lead sponsor
Società Italiana di Medicina Interna
Collaborator
Source ClinicalTrials.gov
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