title: Influence of essential amino acids on muscle mass and muscle strength in patients with cerebral stroke during early rehabilitation: protocol and rationale of a randomized clinical trial (AMINO-Stroke Study).
abstract: BACKGROUND
  Patients with stroke are at a high risk for long-term handicap and disability. In the first weeks after stroke muscle wasting is observed frequently. Early post-stroke rehabilitation programs are directed to improve functional independence and physical performance. Supplementation with essential amino acids (EAAs) might prevent muscle wasting and improve rehabilitation outcome by augmenting muscle mass and muscle strength. We aim to examine this in a double blinded, randomized placebo-controlled clinical trial.
  
  
  METHODS
  Patients with ischemic or haemorrhagic stroke will be enrolled at begin of the early post-stroke rehabilitation in a parallel group interventional trial. Oral supplementation of EAAs or placebo will be given for 12 weeks in a double blinded manner. Physical and functional performance will be assessed by exercise testing before supplementation of EAAs as well as at discharge from the in-patient rehabilitation, at 12 weeks and 1 year afterwards.
  
  
  CONCLUSIONS
  This is the first randomized double-blinded placebo-controlled clinical study aiming to assess the effect of the EAAs supplementation on muscle strength, muscle function and physical performance in stroke patients during early post-stroke rehabilitation. Supplementation of EAAs could prevent muscle mass wasting and improve functional independence after stroke.
  
  
  BACKGROUND
  The study is registered at the German registry for clinical trials as well as at World Health Organization (WHO; number DRKS00005577).
authors.affiliation: Center for Stroke Research Berlin CSB, Charité - Universitätsmedizin Berlin, Berlin, Germany.|German Centre for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany.
authors.forename: Nadja
authors.initials: N
authors.lastname: Scherbakov
authors.affiliation: Innovative Clinical Trials, Department of Cardiology and Pneumology, University MedicineGöttingen (UMG), Göttingen, Germany.
authors.forename: Nicole
authors.initials: N
authors.lastname: Ebner
authors.affiliation: Innovative Clinical Trials, Department of Cardiology and Pneumology, University MedicineGöttingen (UMG), Göttingen, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Sandek
authors.affiliation: Center for Stroke Research Berlin CSB, Charité - Universitätsmedizin Berlin, Berlin, Germany.|Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Meisel
authors.affiliation: Center for Stroke Research Berlin CSB, Charité - Universitätsmedizin Berlin, Berlin, Germany.|Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Karl Georg
authors.initials: KG
authors.lastname: Haeusler
authors.affiliation: Innovative Clinical Trials, Department of Cardiology and Pneumology, University MedicineGöttingen (UMG), Göttingen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: von Haehling
authors.affiliation: Innovative Clinical Trials, Department of Cardiology and Pneumology, University MedicineGöttingen (UMG), Göttingen, Germany.
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.affiliation: Center for Stroke Research Berlin CSB, Charité - Universitätsmedizin Berlin, Berlin, Germany.|German Centre for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany.|Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dirnagl
authors.affiliation: Department of Neurology, Brandenburgklinik Bernau, Bernau, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Joebges
authors.affiliation: Center for Stroke Research Berlin CSB, Charité - Universitätsmedizin Berlin, Berlin, Germany. wolfram.doehner@charite.de.|German Centre for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany. wolfram.doehner@charite.de.|Department of Cardiology, Charité - Universitätsmedizin Berlin, Berlin, Germany. wolfram.doehner@charite.de.
authors.forename: Wolfram
authors.initials: W
authors.lastname: Doehner
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000601:Amino Acids, Essential / Q000008:administration & dosage / Q000494:pharmacology*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength / Q000187:drug effects / Q000502:physiology; D018482:Muscle, Skeletal / Q000187:drug effects / Q000473:pathology; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D020521:Stroke / Q000188:drug therapy / Q000473:pathology; D000071939:Stroke Rehabilitation
chemical_list: D000601:Amino Acids, Essential