Effects of Nutrition on Post Stroke Fatigue

NCT05728229 | Recruiting

• 1 other identifier: 0033318/22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Stroke

Keywords

Stroke; Fatigue; Older Adults; Nutrition

Outcome Measures

Primary Outcomes (1)

• Modified Fatigue Impact Scale (MFIS)

  The MFIS is an instrument that provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items while the abbreviated version has 5 items. The MFIS is a structured, self-report questionnaire that the patient can generally complete with little or no intervention from an interviewer. However, patients with visual or upper extremity impairments may need to have the MFIS administered as an interview. Interviewers should be trained in basic interviewing skills and in the use of this instrument. The total score for the MFIS is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items.

  Change from Baseline MFIS at 4, 8 and 16 weeks

Secondary Outcomes (18)

• Fatigue Scale for Motor and Cognitive Function (FSMC)

  Change from Baseline FSMC at 4, 8 and 16 weeks

• Berg Balance Scale (BBS)

  Change from Baseline BBS at 4, 8 and 16 weeks

• Short Physical Performance Battery (SPPB)

  Change from Baseline SPPB at 4, 8 and 16 weeks

• Motricity Index (MI)

  Change from Baseline MI at 4, 8 and 16 weeks

• Timed Up and Go Test (TUG)

  Change from Baseline TUG at 4, 8 and 16 weeks

Study Arms (2)

Experimental Group (GS)

EXPERIMENTAL

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.

Drug: Supplement with SiderAl® Med

Control Group (GC)

NO INTERVENTION

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.

Interventions

Supplement with SiderAl® Med DRUG

Nutritional supplementation with special purpose food

Also known as: SiderAl® Med

Experimental Group (GS)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Fatigue; Stroke

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Silvia Giovannini, MD, phD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Giovannini, MD, phD

CONTACT

+390630154382; silvia.giovannini@policlinicogemelli.it

Letizia Castelli, MS

CONTACT

+390630154382; letizia.castelli@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Interventional randomized controlled pilot study

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 15, 2023
• Study Start: November 7, 2022
• Primary Completion: September 29, 2024
• Study Completion: December 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2024-12

Locations

IT (1)