Effetti Della Nutrizione Sulla Fatica Post Stroke

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Fatigue, which is commonly defined as a feeling of tiredness during or after usual activities, or a feeling of insufficient energy to initiate these activities, is one of the most common secondary conditions among patients presenting with stroke. Post Stroke Fatigue (PSF) is a multidimensional motor-perceptual, emotional, and cognitive experience characterized by a feeling of early exhaustion with tiredness, lack of energy, and difficulty making efforts, which develops during physical or mental activities, and usually does not improve with rest. To try to counteract fatigue and its effects on daily life activities, in addition to the known pharmacological approach (Modafinil), the use of vitamins and minerals is known to mitigate, among others, the effects of fatigue. Nutrients provide the energy needed to maintain the body's structural and biochemical integrity. Energy is associated with a feeling of well-being, increased stamina and vitality which often translates into the ability to undertake daily physical or cognitive activities and social relationships, as opposed to fatigue. A common feature of fatigue is a sense of energy exhaustion which can objectively be related to not enough energy. Physical and cognitive tiredness occurs when the continuous demand for energy from the brain and muscles is not met. In humans, dietary macronutrients provide the fuel needed, among other things, to perform physical activity. In fact, mineral salts and vitamins are essential for the production of cellular energy, for the maintenance of brain structures and for allowing the formation of intercellular connections. When the intake of vitamins and mineral salts is adequate, their biochemical properties translate into normal physiological functions; a lower intake of mineral salts and vitamins is associated with lethargy and physical and cognitive fatigue. However, few studies have evaluated the effect of vitamin and mineral supplementation for the management of physical and cognitive fatigue. SiderAL® Med is a food for Special Medical Purposes (AFMS), with a complete formulation that contains vitamins, sucrosomial minerals (Iron, Iodine, Magnesium, Zinc and Selenium), copper and algal calcium, with enhanced dosages to meet particular needs nutritional. AFMS are products formulated for the dietary management of patients with proven nutritional needs, for whom modifications to the normal diet are not sufficient. In some cases, these are subjects with limited, disturbed or altered ability to take, digest, absorb, metabolize or eliminate certain nutrients, in other cases, however, nutritional needs can be determined by specific clinical conditions. On the basis of scientific evidences, therefore, the aim of the study is to evaluate whether the nutritional supplement with SiderAL® Med improves the symptom of fatigue, motor and cognitive function in patients with stroke outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• Age greater than or equal to 5 years;

• Patients with ischemic or haemorrhagic stroke outcomes documented through neuroimaging techniques (magnetic resonance or computed tomography);

• Latency from the acute event between 1 and 6 months;

• Cognitive skills that allow you to carry out simple orders and understand the physiotherapist's instructions \[assessed through the Token Test (score ≥ 26.5)\];

• Ability to walk independently or with little assistance;

• Ability to understand and sign informed consent.

Locations
Other Locations
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Silvia Giovannini, MD, phD
silvia.giovannini@policlinicogemelli.it
+390630154382
Backup
Letizia Castelli, MS
letizia.castelli@policlinicogemelli.it
+390630154382
Time Frame
Start Date: 2022-11-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 120
Treatments
Experimental: Experimental Group (GS)
GS patients, in addition to the pharmacological therapy foreseen by the clinical conditions, will take 1 sachet a day of SiderAl® Med, a food for special purposes, for 28 days. GS patients will take the food for special purposes during hospitalization (between T0 and T1) and during the 1 month of returning home (between T1 and T2). During the second month of returning home (between T2 and T3), GS patients will no longer take the food for special purposes.
No_intervention: Control Group (GC)
The patients of the GC, on the other hand, will continue to take the drug as required by their clinical conditions and will not take the SiderAL® Med food for special purposes, but will only be observed and evaluated at the various time-points foreseen by the study.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov