Nutritional Status in Subacute Stroke Patients Under Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Recently, is becoming more evident a relationship between malnutrition, stroke-related
      sarcopenia and/or altered systemic oxidative status in patients with subacute stroke .

      The aim of this study is the evaluation of nutritional status, the presence of stroke-related
      sarcopenia and systemic oxidative status in patients with subacute stroke outcomes; another
      aim is to investigate the correlation of nutritional status, the presence of stroke-related
      sarcopenia and systemic oxidative status on admission with the rehabilitative outcomes.
    

Detailed description: 
      Stroke is the third leading cause of mortality and the second leading cause of permanent
      disability in adults, and is therefore very expensive. Some patients with stroke outcomes,
      regardless of baseline motor and cognitive function, for unknown reasons show an unexpectedly
      worse outcome than others and this suggests other factors, in addition to the degree of
      initial disability, that influence the response to rehabilitative treatment.

      Nutrition is an essential aspect in the overall picture of the stroke patient. Malnutrition
      in the hospital setting is an important issue that can negatively influence the
      rehabilitation outcome (Cederholm et al. 2017; 2019).

      Malnutrition is also responsible for the increase in complications, negatively affects the
      results of treatment, reduces the immune response and predisposes to infections, delays
      healing, compromises the function of organs and systems, reduces muscle mass and strength,
      induces psychic effects with depression and low interest in food.

      All this leads to a demand for greater and more prolonged care, with a delay in the recovery
      of the performance (National Guidelines for hospital and care catering. Min. of Health,
      2015).

      A picture of malnutrition also leads to an alteration of biochemical and haematochemical
      indexes. Our retrospective pilot study on 30 patients with subacute stroke, showed a positive
      correlation between the reduction of disability following rehabilitation treatment and the
      calcium at admission (Siotto et al, 2020). In addition, a recent study with 100 patients
      admitted to a rehabilitation unit showed that the functional status at the time of admission
      and the improvement following the rehabilitation program were positively influenced by high
      blood levels of vitamin D (Lelli et al. 2019).

      Malnourished patients experience "sarcopenia", which is characterized by the reduction of
      muscle mass and strength, and is a phenomenon strongly related to age: after the age of 70
      years, in fact, there is a loss of 15% of muscle mass. It is a risk factor for falls,
      fractures, physical disability and mortality and it is a phenomenon dependent on various
      factors such as metabolic imbalance, inactivity, malnutrition and inflammatory states.
      Sarcopenia is accompanied by body weight loss, neuro-hormonal activation and a systemic shift
      towards catabolic over-activation (Knops et al. 2013).

      Sarcopenia is frequently found in patients with stroke outcomes and can contribute negatively
      to the rehabilitation process. A recent study of 267 stroke patients admitted to a
      rehabilitation unit showed that those with sarcopenia (n=129 48%) had severe lower limb
      paralysis, lower Body Mass Index (BMI) values and a lower Functional Independence Measure
      (FIM) score, compared to patients without sarcopenia. In addition, patients with sarcopenia
      had a longer average stay with less chance of returning home and were less autonomous in
      walking. Finally, patients with sarcopenia showed a lower recovery of functional autonomy
      compared to non sarcopenic patients (Matsushita et al. 2019).

      In stroke patients there is also "stroke-related sarcopenia" (Scherbakov, Sandek, and Doehner
      2015) with distinctive features. The reasons are to be attributed to a complex of
      pathophysiological reactions including: altered neurovegetative control, alterations in the
      local and systemic metabolic system, difficulty in nutrition and inflammation (Scherbakov,
      Sandek, and Doehner 2015).

      Some studies have led to hypothesize a correlation between sarcopenia and systemic oxidative
      stress. The general oxidative state is the result between levels of circulating oxidants
      (e.g. peroxides) and levels of endogenous or dietary acquired antioxidants (glutathione or
      vitamins, such as tocopherols, vitamin E, K). Our research team has recently demonstrated
      that circulating peroxides increase in stroke and are related to clinical severity (Squitti
      et al., 2018). The measurement of circulating peroxides evaluates the prooxidant state of a
      subject because it depends on circulating free radicals (Reactive Oxygen Species, ROS); these
      molecules have a great chemical reactivity, which, in extreme cases, compromises the function
      of all cellular macromolecules causing cell death; for this reason it is thought that
      sarcopenia may be at least partly due to an over-regulation of oxidative metabolism that
      produces high levels of circulating free radicals (Fulle et al. 2004).

      The hypothesis of the study is that there is a negative relationship between malnutrition,
      stroke-related sarcopenia and/or altered systemic oxidative status in patients on admission
      and recovery following rehabilitative treatment.

      therefore the aims of this study are:

        -  Evaluation of nutritional status, presence of stroke-related sarcopenia and systemic
           oxidative status in patients with subacute stroke outcomes;

        -  the correlation of nutritional status, the presence of stroke-related sarcopenia and
           systemic oxidative status on admission with the rehabilitative outcome.

      Improving the nutritional picture of stroke patients from acute or post-acute wards will lead
      to a faster and more effective motor recovery and improve their autonomies and quality of
      life. This may lead to a lower impact of disability on families and caregivers and, more
      generally, a reduction in health care costs.

      Longitudinal prospective multicentric, non-profit, longitudinal observational study conducted
      in patients with first stroke (ischemic or hemorrhagic) in subacute phase (within six months
      after the acute event). The study involves the collection of clinical, instrumental and
      biochemical data that do not deviate from routine clinical practice. Since it is not an
      experimental study, no specific intervention is planned; patients will be observed before and
      after the usual rehabilitative intervention.

      The study will have a total duration of 18 months starting in January 2021 and a patient
      enrolment time of 1 year.
    

Intervention name(s): robotic assisted intervention; biochemical analyses; BIA, hand grip; nutritional assessment, MNA
Intervention type(s): Device; Diagnostic Test; Device; Diagnostic Test
Intervention description(s): Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.; ematochemical and biochemical serum analyses at T0 and at T1; oxidative stress analyses;; bioimpedentiometric analyses of muscular mass (T0 and T1) , muscular force with hand grip; nutritional status assessment with MNA, body mass index measurements, weight loss detection, food income detection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with first ischemic stroke (of ischemic or hemorrhagic aetiology) in subacute
        phase (within six months after the acute event), hospitalized at the participating
        intensive-extensive rehabilitation centers will be included.
      
Keywords: Stroke; Nutrition; Rehabilitation; Oxidative stress; Sarcopenia