Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923165
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2021-02-22
Brief Title:
Nutritional Status in Subacute Stroke Patients Under Rehabilitation
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Influence of Nutritional Status on Rehabilitation Outcome in Subacute Stroke Patients
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nutristroke
Brief Summary:
Recently is becoming more evident a relationship between malnutrition stroke-related sarcopenia andor 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
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 n129 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 eg 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 andor 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
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 n129 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 eg 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None