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).

Nadja Scherbakov,Wolfram Doehner,Andreas Meisel,Anja Sandek,Stephan Von Haehling,Michael Joebges,Karl Georg Haeusler,Nicole Ebner,Ulrich Dirnagl,Stefan D Anker

doi:10.1186/s12883-016-0531-5

Abstract

BackgroundPatients 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.MethodsPatients 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.DiscussionThis 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.Trial registrationThe study is registered at the German registry for clinical trials as well as at World Health Organization (WHO; number DRKS00005577).

Highlights

Patients with stroke are at a high risk for long-term handicap and disability
We aim to demonstrate that nutritional supplementation with biologically limited available essential amino acids (EAAs) (l-leucine, l-lysine, l-isoleucine, l-valine, l-threonine, l-cystine, lhistidin, l-phenylalanine, l-methionine, l-tyrosin, and ltryptophane), in synergy with individually adjusted physical training prevent muscle wasting after stroke and improve the effect of post-stroke early rehabilitation
The present AMINO Stroke study will be the first randomized double-blinded trial investigating an effect of essential amino acids (EAAs) on skeletal muscle functional capacity, muscle mass, muscle strength and physical performance in early post-stroke rehabilitation

Summary

Introduction

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. Long-term disability and functional dependency are the main complications after stroke. Loss of muscle mass and muscle function, defined as sarcopenia, have been originally described as a phenomenon of aging [5]. Muscle wasting observed in stroke patients is a disease-related phenomenon and the term ‘stroke-related sarcopenia’ has been suggested [1]. The aetiology of sarcopenia is multifactorial [6] Stroke-related muscle wasting is accompanied by body weight loss, neuro-hormonal activation, and a systemic shift towards catabolic over-activation [8]. Activation of catabolic pathways in the skeletal muscle of the paretic and non-paretic limbs has been observed in experimental stroke [9]

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