Effects of exercise with probiotics, exercise alone, and probiotics alone on physical, motor, affective, and cognitive functions in stroke patients: a randomised controlled trial.

BACKGROUND: Physical and neuropsychiatric disturbances often persist after stroke, necessitating innovative rehabilitation strategies. Combining exercise with probiotics may synergistically enhance recovery by leveraging neuroplasticity and modulation of the gut-brain axis. This study evaluated the individual and combined effects of exercise and probiotics in stroke patients. METHODS: Ninety-six patients (32 per group) within 1 year post-stroke were randomized to exercise with probiotics (EWP) (90 min/session multimodal exercise, 3 times weekly, plus probiotics, 1 capsule/day, 3.3 billion CFU Lactobacillus rhamnosus and Bifidobacterium lactis, for 8 weeks), exercise alone (EA), or probiotics alone (PA). The primary outcomes of physical disability (modified Rankin Scale [mRS]) and depression (Hospital Anxiety and Depression Scale [HADS]-depression sub-scale) and secondary outcomes of motor function (Supplemental Motor Scale of National Institute of Health Stroke Scale [SMSNIHSS]), anxiety (HADS-anxiety sub-scale), and cognition (Montreal Cognitive Assessment [MoCA]) were assessed at baseline, 4th week, and 8th week. RESULTS: EWP showed significantly greater improvements in mRS (p < 0.05, η² = 0.26 at week 4, 0.46 at week 8), SMSNIHSS (p < 0.05, η² = 0.08 at week 4, 0.24 at week 8), HADS-D (p < 0.05, η² = 0.24 at week 8), HADS-A (p < 0.05, η² = 0.07 at week 4, 0.26 at week 8), and MoCA (p < 0.05, η² = 0.18 at week 4, 0.46 at week 8) compared to EA and PA at weeks 4 and 8, except for HADS-D at week 4 (p > 0.05, η² = 0.04). At week 8, EA significantly outperformed PA in mRS, SMSNIHSS, and MoCA (p < 0.05), but not HADS-D or HADS-A (p > 0.05). Transient stomach upset occurred in 9.4% (PA) and 6.3% (EWP), resolved with water. EA reported no adverse events. CONCLUSION: EWP showed superiority compared to either intervention alone in improving physical and motor functions, mood, and cognition in stroke patients. EA outperforms PA in physical, motor, and cognitive outcomes but shows comparable effects on depression and anxiety. Minimal adverse events support EWP's feasibility. These findings underscore the possibility of integrating exercise with probiotics to optimize post-stroke recovery in multiple domains. TRIAL REGISTRATION: Pan African Clinical Trial Registry (PACTR202408541705549), 13/08/2024.