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Effects of mindfulness and exercise on cognition and emotion in adults with mild deficits in the chronic post-stroke phase: a randomized controlled trial [with consumer summary]
Bermudo-Gallaguet A, Ariza M, Agudelo D, Camins-Vila N, Boldo M, Ferrer-Uris B, Busquets A, Pera G, Caceres C, Gomis M, Dacosta-Aguayo R, Clemente IC, Garcia-Molina A, Mata MJD, Toran-Monserrat P, Erickson KI, Mataro M
Annals of Physical and Rehabilitation Medicine 2025 Oct;68(7):102008
clinical trial
This trial has not yet been rated.

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 plus CCT, PE plus 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 plus CCT, 34 in PE plus 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 plus 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 plus 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 plus CCT increased fitness, and MBSR plus 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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