Sarcopenia in Acute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population comprises patients with acute ischemic stroke admitted within the first 72 hours after symptom onset.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline and 14 days2
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.
Time frame
Baseline and 90 daysSecondary outcomes
1
Number of Participants with sarcopenia
Time frame
Baseline2
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.
Time frame
Baseline, 14 and 28 days3
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.
Time frame
Baseline, 14 and 28 days4
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.
Time frame
Baseline, 14 and 28 days.Sponsors and contacts
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Source ClinicalTrials.gov