SarcopeniaNCT07764172
Sarcopenia in Acute Ischemic Stroke
An observational study of Sarcopenia and Acute Stroke, run by University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba) at 1 site in Russia.
Trial summary
The objective of this observational study is to determine the prevalence of sarcopenia in patients aged 50 years and older with acute ischemic stroke, to characterize its trajectory during the acute phase using instrumental verification and functional-cognitive assessments, and to evaluate its impact on functional… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sarcopenia, Acute Stroke
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2026to 31 Dec 2029
- Phase
- Observational
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 50 years and older
- All sexes
- Adult, Older adult
Study population: The study population comprises patients with acute ischemic stroke admitted within the first 72 hours after symptom onset.
Who may be able to join
- Age 50 years and older
- Acute ischemic stroke confirmed by CT or MRI
- Admission within the first 72 hours
- Written informed consent and availability of a contact telephone number for follow-up
Who cannot join
- TIA without a visible lesion on neuroimaging; bilateral hemiparesis
- Amputations or severe contractures that preclude anthropometric assessment
- Active cancer at stage IV or life expectancy of less than 3 months
- Neuromuscular diseases; chronic use of systemic glucocorticoids for more than 3 months
- Pregnancy; refusal to participate
- Discontinuation criteria (drop-out)
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- Discharge or death within the first 7 days
- Withdrawal of consent
- Transfer to another facility resulting in loss of contact
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Moscow State Budgetary Healthcare Institution "Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department"
Moscow, 115446
Naida Garabova, PhD, +79611080888, garabova-ni@rudn.ru
About this study
Official title: Sarcopenia in Patients During the Acute Phase of Ischemic Stroke: Multimodal Assessment and Three-Month Functional Outcomes
The objective of this observational study is to determine the prevalence of sarcopenia in patients aged 50 years and older with acute ischemic stroke, to characterize its trajectory during the acute phase using instrumental verification and functional-cognitive assessments, and to evaluate its impact on functional outcome at three months. The main research question is:
Is the presence of sarcopenia at admission associated with less favorable stroke outcomes, including higher rates of complications and mortality?
Participants receiving standard medical care for acute ischemic stroke will undergo extended functional assessment for sarcopenia, and a subset will additionally undergo cognitive evaluation.
- Conditions
- Sarcopenia, Acute Stroke
- Keywords
- sarcopenia, acute stroke
- Medical subject headings
- Sarcopenia, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Barthel Index for Activities of Daily Living at 14 days
Lower scores indicate increasing disability and a greater need for skilled care. Min - 0 ( < 20 - totally dependent), max - 100 ( > 80 - independent).
Measured: Baseline and 14 days
Change from Baseline in Modified Rankin scale at 90 days
Min - 0 (no disability), max - 6 (dead). A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
Measured: Baseline and 90 days
Secondary outcomes (11)
Number of Participants with sarcopenia
Measured: Baseline
Change from Baseline in arm muscle mass at 14 and 28 days.
Mid-upper arm circumference: measured at the midpoint between the acromion and the olecranon with the arm relaxed (2 measurements) in cm. Arm muscle circumference and area are calculated using the Heymsfield formula.
Measured: Baseline, 14 and 28 days
Change from Baseline in calf circumference at 14 and 28 days
Calf circumference: measured in the seated position, with the knee at a right angle, at the widest part of the non-paretic calf, with the tape snug but without compression (2 measurements) in cm. Calf circumference below 34 cm in men and 33 cm in women is classified as reduced.
Measured: Baseline, 14 and 28 days
Change from Baseline in handgrip strength at 14 and 28 days.
Handgrip dynamometry: performed in the seated position with the elbow at a right angle; three trials on the non-paretic hand, with the mean value used for analysis. Handgrip strength of the non-paretic hand below 27 kg in men and 16 kg in women is classified as reduced.
Measured: Baseline, 14 and 28 days.
Correlations between anthropometric measures and ultrasound/CT parameters
Measured: Baseline, 14, 28, and 90 days
Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) at 24 hours, 7 and 14 days.
Min - 0, max - 42. A higher score means a patients has more severe symptoms. Patients with a score of <4 are highly likely to have good clinical outcomes.
Measured: Baseline, 24 hours, 7 and 14 days.
Change from Baseline in Rivermead Mobility Index at 14 and 28 days.
Min - 0, max - 15. Higher scores indicate better mobility performance. A score of 0 indicates an inability to complete any of the 15 tasks.
Measured: Baseline, 14 and 28 days.
Mortality at 14 and 90 days
Mortality rate at 14 and 90 days
Measured: 14 and 90 days
Hospital length of stay
Days. Total number of days spent admitted to the hospital during the index hospital stay, calculated from admission date to final discharge date.
Measured: Up to 28 days
Intensive care unit length of stay
Days. Total number of days spent in the intensive care unit from the time of initial ICU admission to successful transfer or discharge to a step-down unit.
Measured: Up to 28 days
Number of Participants with recurrent events within 90 days
Measured: From baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Aug 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (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.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764172
- Sponsor's protocol ID
- ACUTE-SARC-MC-2026
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Individual data sharing
- Undecided