Trial document




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  DRKS00005577

Trial Description

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Title

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

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Trial Acronym

AMINOS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The effect of essential amino acid supplementation on muscle wasting, muscle strength, mobility, and self-dependence in patients during rehabilitation after acute stroke

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Brief Summary in Scientific Language

To assess the effect of essential amino acid supplementation on muscle wasting, muscle strength, mobility, and self-dependence in patients during rehabilitation after acute stroke

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Organizational Data

  •   DRKS00005577
  •   2014/01/13
  •   [---]*
  •   yes
  •   Approved
  •   S13(a)/2013, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I63.5 -  Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
  •   I63.8 -  Other cerebral infarction
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Interventions/Observational Groups

  •   oral administration of 12 g essential amino acids/day for 4 weeks
  •   Control intervention:
    oral administration of matching placebo for 4 weeks
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

All parameters were analyzed at the begining of the study and after 4 weeks of treatment.
• To evaluate the effect of essential amino acids on health-related quality of life in patients 3 months after stroke (EQ-5D, PGA, SF36)
To assess the effect of essential amino acids compared with placebo:
• On stroke related disability and functional independence (Barthel-Index, modified Rankin Scale) of patients at the end of in-hospital rehabilitation after stroke
• On stroke related disability and functional independence (Barthel-Index, modified Rankin Scale) of patients at 3 months after stroke
• On functional rehabilitation success (pinch strength, motor assessment scale, Fugl-Meyer Score (motor functional domain), functional ambulatory category (FAC), short physical performance battery test)
• On body composition changes and the development of cachexia in the course of post stroke rehabilitation
• On insulin sensitivity in the course post stroke rehabilitation
• On nutritional status and metabolic profile in the course of post stroke rehabilitation
• On number, rate and duration of hospitalizations for any reason
• On development of post stroke infection
• On development of any stroke related complication
• To evaluate the tolerability and safety of essential amino acids: Safety endpoints for tolerability will include recording of adverse events and serious adverse events during follow-up.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/01/06
  •   110
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Center for Stroke Research, Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
    • Mr.  Prof. Dr. Dr.  Wolfram  Doehner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Center for Stroke Research, Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
    • Mr.  Prof. Dr. Dr.  Wolfram  Doehner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Center for Stroke Research, Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
    • Mr.  Prof. Dr. Dr.  Wolfram  Doehner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Forschungsbudgetdes IFB Centrum für Schlaganfallforschung, Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
    • Mr.  Prof. Dr. Dr.  Wolfram  Doehner 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.