Effect of intensive nutritional support on functional recovery in subacute stroke: A randomized, multicenter, single-blinded trial

Background: Nutrition in the subacute phase of stroke may be a critical factor in functional recovery and post-stroke mortality. Nevertheless, the issue of intensive nutritional support for people with subacute stroke remains insufficiently explored. Objectives: This study investigated the effects of intensive nutritional support during rehabilitation on functional recovery in the subacute phase of participants with a first-ever stroke. Methods: This randomized, single-blinded, parallel-designed study is part of the Korean Stroke Cohort for Functioning and Rehabilitation, a 10-year long-term follow-up of stroke participants. A total of 91 first-ever stroke participants were recruited from 5 hospitals and randomly allocated to the intensive nutrition (IN) group (n = 43) or the conventional nutrition (CN) group (n = 48). All participants received the same comprehensive inpatient stroke rehabilitation. During the three-week intervention period, the IN group received an additional 500 kcal daily by intravenous nutritional infusion, while both groups received usual nutrition. Functional assessments and nutritional status were evaluated at baseline, post-intervention, and 6 months after stroke onset. Repeated measures ANOVA and post-hoc analyses were used for intention-to-treat analysis. Results: Baseline characteristics were not significantly different between the groups. The dropout rate was significantly higher in the IN group (20 %) than in the CN group (2 %). A repeated measures ANOVA demonstrated significant interactions between time and intervention for the modified Barthel index (P = 0.02, η² = 0.05, small) and nutrition risk screening 2002 (P = 0.03, η² = 0.03, small), indicating significant improvements in the IN group. The modified Barthel Index, Nutrition Risk Screening 2002, and Functional Ambulation Category demonstrated significantly higher changes in the IN group compared to the CN group between time points. Conclusions: Intensive nutritional support during comprehensive rehabilitation could provide additional functional improvement in subacute stroke participants. However, alternative methods of intensive nutrition should be explored, as intravenous nutritional infusions were not well-tolerated by some participants. Clinical Trial Registry number and website: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04259307.