Effect of Essential Amino Acids on Muscle Size and Strengthin Patients with Acute Ischemic Stroke during Rehabilitation

Not Applicable

Recruiting

• Conditions: I63.5; I63.8; Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries; Other cerebral infarction

• Registration Number: DRKS00005577
• Lead Sponsor: Center for Stroke Research, Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Written informed consent
• Age = 55 years
• Patients admitted to in-hospital rehabilitation after acute stroke
• Ischemic stroke of the anterior (ACA, MCA) or posterior (PCA, BA) territory prior (< 4 weeks) to the present in-hospital rehabilitation
• Brain imaging (CCT, MRT) with evidence of stroke
• Motoric disability of an upper and/or lower limb (Rivermead Motor Assessment Gross Function > 1 and < 11

Exclusion Criteria

• Clinically significant findings on physical examination or presence of known clinically significant disease that would interfere with study evaluation in the opinion of the treating physicians
• Participation in another clinical trial investigating a nutritional product
• History of intolerance or allergic response to similar nutritional products or known hypersensitivity to essential amino acids
• Clinical signs and symptoms of infection requiring antibiotic therapy at the time of enrolment that prevent adequate completion of trial related assessments as judged by the investigator
• Liver transaminases (AST or ALT) > 3 times the upper limit of normal (ULN), or severe renal dysfunction or nephrotic syndrome
• Known HIV or Hepatitis C infection
• Current therapy with anabolic steroids or appetite stimulants
• Current immunosuppressive therapy, heart transplantation, or renal dialysis
• Life expectancy < 6 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of essential amino acids supplementation on <br>1) physical performance (Rivermead Motor Assessment Gross Function) and <br>2) muscle strength (handgrip) in patients with stroke after 4 weeks of dietary supplementation with essential amino acids<br>Parameters are measured in both groups (Aminoacid-treatment and placebo group) time point 4 weeks of treatment.