Clinical trial NCT05728229: Effects of Nutrition on Post Stroke Fatigue
Official title: Effetti Della Nutrizione Sulla Fatica Post Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fatigue
Stroke
Keywords: Stroke
Fatigue
Older Adults
Nutrition
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional randomized controlled pilot study
Primary purpose: TREATMENT

Brief 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.

Detailed description: Twenty-four patients of both sexes will be recruiteed, evaluated and treated at the Post-Acute Rehabilitation Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome.

Patients will be divided into two groups by randomization, as specified later. One group (experimental group, GS), in association with the drug therapy already underway, will take the nutritional supplement with SiderAL® Med 1 sachet per day for 28 consecutive days, while another group will continue its clinical and rehabilitation treatment as per the daily routine (control group, GC).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Vitamin D intake greater than 3000 IU/day;
* Therapy with Vitamin K antagonists;
* Conditions causing excess electrolytes in the blood;
* Diagnosis of metabolic mineral storage disorders (eg, hemochromatosis, Wilson);
* Dialysis patients;
* Systemic, neurological, cardiac pathologies that make walking risky or cause motor deficits;
* Oncological pathologies;
* Problems of an orthopedic or postural nature;
* Presence of plantar ulcers;
* Partial or total amputation of segments of the foot;
* Inability to provide informed consent.

Primary outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline MFIS at 4, 8 and 16 weeks
Secondary outcomes:
measure: Fatigue Scale for Motor and Cognitive Function (FSMC)
timeFrame: Change from Baseline FSMC at 4, 8 and 16 weeks
measure: Berg Balance Scale (BBS)
timeFrame: Change from Baseline BBS at 4, 8 and 16 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from Baseline SPPB at 4, 8 and 16 weeks
measure: Motricity Index (MI)
timeFrame: Change from Baseline MI at 4, 8 and 16 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: Change from Baseline TUG at 4, 8 and 16 weeks
measure: HandGrip Test (HGT)
timeFrame: Change from Baseline HGT at 4, 8 and 16 weeks
measure: Ambulation Index (AI)
timeFrame: Change from Baseline AI at 4, 8 and 16 weeks
measure: Walking handicap scale (WHS)
timeFrame: Change from Baseline WHS at 4, 8 and 16 weeks
measure: Functional Ambulation Classification (FAC)
timeFrame: Change from Baseline FAC at 4, 8 and 16 weeks
measure: 10 Meter Walk Test (10mWT)
timeFrame: Change from Baseline 10MWT at 4, 8 and 16 weeks
measure: Six-minute walk test (6MWT)
timeFrame: Change from Baseline 6MWT at 4, 8 and 16 weeks
measure: modified Barthel Index (mBI)
timeFrame: Change from Baseline mBI at 4, 8 and 16 weeks
measure: EuroQol- 5 Dimension (EQ-5D)
timeFrame: Change from Baseline EQ-5D at 4, 8 and 16 weeks
measure: Frontal Assessment Battery (FAB)
timeFrame: Change from Baseline FAB at 4, 8 and 16 weeks
measure: Stroop Colour Word Test (SCWT)
timeFrame: Change from Baseline SCWT at 4, 8 and 16 weeks
measure: Digit Cancellation Test (DCT)
timeFrame: Change from Baseline DCT at 4, 8 and 16 weeks
measure: Trial Making Test (TMT)
timeFrame: Change from Baseline TMT at 4, 8 and 16 weeks
measure: Dual-Energy X-ray Absorptiometry (DEXA)
timeFrame: Change from Baseline DEXA at 4, 8 and 16 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Silvia Giovannini, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: