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).
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