Nutritional Status in Subacute Stroke Patients Under Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-04

Study Completion Date

2023-04-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with stroke

Inpatients and outpatients admitted to the investigators' rehabilitation facility .

robotic assisted intervention

Intervention Type DEVICE

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.

biochemical analyses

Intervention Type DIAGNOSTIC_TEST

ematochemical and biochemical serum analyses at T0 and at T1; oxidative stress analyses;

BIA, hand grip

Intervention Type DEVICE

bioimpedentiometric analyses of muscular mass (T0 and T1) , muscular force with hand grip

nutritional assessment, MNA

Intervention Type DIAGNOSTIC_TEST

nutritional status assessment with MNA, body mass index measurements, weight loss detection, food income detection

Interventions

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robotic assisted intervention

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.

Intervention Type DEVICE

biochemical analyses

ematochemical and biochemical serum analyses at T0 and at T1; oxidative stress analyses;

Intervention Type DIAGNOSTIC_TEST

BIA, hand grip

bioimpedentiometric analyses of muscular mass (T0 and T1) , muscular force with hand grip

Intervention Type DEVICE

nutritional assessment, MNA

nutritional status assessment with MNA, body mass index measurements, weight loss detection, food income detection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* stroke patients (hemorrhagic or ischemic) documented through Magnetic Resonance Imaging (MRI) or Computed Tomography (CT);
* age between 18 and 85 years;
* latency time within 6 months after the stroke event
* sufficient cognitive and language skills to understand the instructions related to the administration of the assessment scales and to sign informed consent

Exclusion Criteria

* presence of a previous stroke based on the medical history;
* behavioral and cognitive disorders that may interfere with the therapeutic activity;
* other orthopedic or neurological complications that may interfere with the rehabilitation protocol;
* inability to understand and sign informed consent;
* presence of pacemakers (for interference with bioimpedance measures).

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No