The role of nutritional supplement on post-stroke fatigue: a pilot randomized controlled trial

Objectives: Post-stroke fatigue (PSF) is an experience characterized by an early feeling of exhaustion with fatigue, a\r\nlack of energy, and difficulty in exertion, both motor and cognitive. To counteract fatigue and limit its effects on\r\nactivities of daily living, the use of vitamins and minerals is known in addition to the pharmacological approach.\r\nHowever, few studies have evaluated the effect of vitamin and mineral supplementation on fatigue management.\r\nSiderAL Med is a food for special medical purposes with a complete formulation containing vitamins, sucrosomal\r\nminerals, copper and algal calcium. The aim of the study is to evaluate whether nutritional supplementation with\r\nSiderAL Med improves the symptom of fatigue and motor and cognitive function in stroke patients.\r\nDesign: This is a pilot, randomized study with a control group.\r\nSetting: Post-Acute Rehabilitation Unit of the Fondazione Policlinico “A. Gemelli” IRCCS.\r\nParticipants: Twenty-four patients with stroke outcomes, admitted to rehabilitation, were recruited and randomized\r\ninto the experimental group (Sid-G) and the control group (CG).\r\nIntervention: The Sid-G patients, in association with the pharmacological and rehabilitation therapy foreseen during\r\nhospitalization, took SiderAL1 Med, one sachet per day for 8 weeks, while the CG patients underwent only the\r\npharmacological and rehabilitation therapy foreseen in the daily routine.\r\nMeasurements: All patients were assessed at baseline (T0), after 4 weeks (T1), after 8 weeks (T2) and after 12 weeks\r\n(T3) for motor and cognitive fatigue, balance, walking, functional capacity, cognitive performance, autonomy,\r\nquality of life and body composition.\r\nResults: Both Sid-G and CG patients showed significant improvement on most rating scales between T0-T1-T2-T3 (p=0.0001). When comparing the two groups, a statistically significant difference emerged in favor of Sid-G with\r\nregard to motor fatigue (p=0.007), cognitive fatigue (p=0.009) and total fatigue (p=0.034); balance (p<0.001), functional capacity (p<0.001); cognitive performance (p=0.004); bone mineral content (p=0.005), lean\r\nmass (p=0.005), total mass (p<0.001) and percentage of fat mass (p=0.039).\r\nConclusion: Nutritional supplementation with SiderAL Med, in concert with intensive rehabilitation treatment,\r\nappears to be effective in managing fatigue and improving motor and cognitive performance and body composition,\r\nrepresenting a valuable tool to associate with rehabilitation treatment in stroke patients.