Background: Individuals with stroke often face cognitive and emotional challenges. Mindfulness-based stress reduction (MBSR), physical exercise (PE), and computerized cognitive training (CCT) are promising approaches to incorporate into post-stroke rehabilitation.
Objectives: To determine whether adding MBSR or PE to CCT improves cognition and mental health more than CCT alone, and whether any benefits are mediated by gains in mindfulness or fitness.
Methods: The MindFit Project was a single-blind, parallel, 3-arm randomized controlled trial enrolling participants with chronic stroke, assigned to MBSR+CCT, PE+CCT, or CCT-only (1:1:1). All 12-week, home-based interventions were delivered online, with 5 sessions per week. The primary outcomes included 3 cognitive and 2 mental health measures; mindfulness and physical fitness were also assessed. Analyses used per-protocol and intention-to-treat approaches.
Results: A total of 141 individuals (mean [SD] age 57.7 [11.2] years; 40 % women) were randomly assigned to 3 groups (47 each). Participants were 28.54 (20.35) months post-stroke with a mean modified Rankin Scale score of 2.23 (1.04). Of these, 78 % (39 in MBSR+CCT, 34 in PE+CCT, and 37 in CCT-only) achieved an adherence rate of ≥80 % and were included in the per-protocol analysis. No significant between-group differences were found in primary outcomes (all P > 0.05). For secondary outcomes, the PE+CCT group showed significantly greater gains in leg strength than the others (F = 7.50, adjusted P = 0.009). These results were consistent with the intention-to-treat analysis. In the per-protocol sample, improvements in mindfulness significantly mediated emotional outcomes in the MBSR+CCT group (B = -1.08; 95 % bootstrapped CI, -2.77 to -0.01).
Conclusions: In participants with predominantly mild chronic post-stroke deficits, adding MBSR or PE to CCT did not improve primary cognitive or emotional outcomes beyond CCT alone. However, PE+CCT increased fitness, and MBSR+CCT yielded mindfulness-mediated emotional gains. Future studies involving larger and more severe stroke samples are needed.
Trial registration: NCT04759950 (www.
Clinicaltrials: gov).
Keywords: Computerized cognitive training; Mindfulness; Physical exercise; Stroke.
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