Effects and mechanisms of mindfulness training and physical exercise on cognition, emotional wellbeing, and brain outcomes in chronic stroke patients: Study protocol of the MindFit project randomized controlled trial

Adrià Bermudo-Gallaguet, Mar Ariza, Rosalia Dacosta-Aguayo, Daniela Agudelo, Neus Camins-Vila, Maria Boldó, Òscar Carrera, Sandra Vidal, Blai Ferrer-Uris, Albert Busquets, Marc Via, Guillem Pera, Cynthia Cáceres, Meritxell Gomis, Alberto García-Molina, José María Tormos, Ana Arrabé, Gustavo Diez, Maria José Durà Mata, Pere Torán-Monserrat, Juan José Soriano-Raya, Sira Domènech, Alexandre Perera-Lluna, Kirk I Erickson, Maria Mataró, Adrià Bermudo-Gallaguet, Mar Ariza, Rosalia Dacosta-Aguayo, Daniela Agudelo, Neus Camins-Vila, Maria Boldó, Òscar Carrera, Sandra Vidal, Blai Ferrer-Uris, Albert Busquets, Marc Via, Guillem Pera, Cynthia Cáceres, Meritxell Gomis, Alberto García-Molina, José María Tormos, Ana Arrabé, Gustavo Diez, Maria José Durà Mata, Pere Torán-Monserrat, Juan José Soriano-Raya, Sira Domènech, Alexandre Perera-Lluna, Kirk I Erickson, Maria Mataró

Abstract

Background: Post-stroke cognitive and emotional complications are frequent in the chronic stages of stroke and have important implications for the functionality and quality of life of those affected and their caregivers. Strategies such as mindfulness meditation, physical exercise (PE), or computerized cognitive training (CCT) may benefit stroke patients by impacting neuroplasticity and brain health.

Materials and methods: One hundred and forty-one chronic stroke patients are randomly allocated to receive mindfulness-based stress reduction + CCT (n = 47), multicomponent PE program + CCT (n = 47), or CCT alone (n = 47). Interventions consist of 12-week home-based programs five days per week. Before and after the interventions, we collect data from cognitive, psychological, and physical tests, blood and stool samples, and structural and functional brain scans.

Results: The effects of the interventions on cognitive and emotional outcomes will be described in intention-to-treat and per-protocol analyses. We will also explore potential mediators and moderators, such as genetic, molecular, brain, demographic, and clinical factors in our per-protocol sample.

Discussion: The MindFit Project is a randomized clinical trial that aims to assess the impact of mindfulness and PE combined with CCT on chronic stroke patients' cognitive and emotional wellbeing. Furthermore, our design takes a multimodal biopsychosocial approach that will generate new knowledge at multiple levels of evidence, from molecular bases to behavioral changes.

Clinical trial registration: www.ClinicalTrials.gov, identifier NCT04759950.

Keywords: biomarkers; computerized cognitive training; mindfulness; neuroimaging; physical exercise; stroke.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Bermudo-Gallaguet, Ariza, Dacosta-Aguayo, Agudelo, Camins-Vila, Boldó, Carrera, Vidal, Ferrer-Uris, Busquets, Via, Pera, Cáceres, Gomis, García-Molina, Tormos, Arrabé, Diez, Durà Mata, Torán-Monserrat, Soriano-Raya, Domènech, Perera-Lluna, Erickson and Mataró.

Figures

FIGURE 1
FIGURE 1
MindFit project graphical objectives. APOE, apolipoprotein E; BDNF, brain-derived neurotrophic factor; CCT, computerized cognitive training; CRP, C-reactive protein; IGF-I, insulin-like growth factor I; IL-6, interleukin-6; MBSR, mindfulness-based stress reduction; PE, physical exercise; VEGF, vascular endothelial growth factor.
FIGURE 2
FIGURE 2
MindFit project study design. CCT, computer-based cognitive training; MBSR, mindfulness-based stress reduction; PE, physical exercise.

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