Clinical trial NCT04759950: Exercise the Mind and Brain. A Multimodal Intervention in Stroke
Official title: Effects of Combined Therapies of Physical Exercise, Mindfulness and Cognitive Stimulation on Cognition and Neuroplasticity in Chronic Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Neuroplasticity
stroke
neuroprotection
physical exercise
cognitive training
mindfulness
neuroimaging
intervention
randomization
blind
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
name: Germans Trias i Pujol Hospital
name: Institut Guttmann
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: University of Pittsburgh
First posted: 2021-02-18
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 141 participants at 3 to 60 months after stroke are randomly allocated to one of three arms: The first group (n=47) receives computer-based cognitive training (CCT) combined with a multicomponent physical exercise program. The second group (n=47) receives CCT combined with mindfulness-based stress reduction therapy. Finally, the third group (n=47), as an active control group, receives only CCT.
Primary purpose: TREATMENT

Brief summary: The main objective of MindFit Project is to develop an evidence-based multimodal investigation of combined non-pharmacological strategies in chronic stroke patients and clarify the neuroplasticity mechanisms underlying the benefits of physical exercise and mindfulness strategies combined with cognitive training on post-stroke recovery. The investigators have adopted a multidisciplinary and multimodal approach to provide a more integrative perspective using cognitive, social-psychological, biochemical, and neuroimaging measurements.

Detailed description: The MindFit Project is a multicentric, prospective, parallel, single-blinded, randomized controlled trial with a sample of 141 participants at 3 to 60 months after stroke. Participants are randomly allocated to one of three arms (through a simple randomizing procedure with a 1:1:1 ratio created with a random sequence generator software).

The first group (n=47) receives computer-based cognitive training (CCT) combined with a multicomponent physical exercise program. The second group (n=47) receives CCT combined with mindfulness-based stress reduction therapy. Finally, the third group (n=47), as an active control group, receives only CCT. All interventions last 12 weeks.

Within two weeks before the start of the interventions, and again at 3 months after completing the interventions, medical, cognitive, and physical assessments, neuroimaging, and biological samples collection are performed.

The objectives of this project are:

1. To examine the effects of multimodal interventions in a population of chronic stroke patients on various domains: cognition, emotion, physical health, and quality of life.
2. To examine specific plasticity effects of each of the three interventions regarding structural and functional magnetic resonance imaging (MRI) and how these changes may contribute to cognitive and emotional benefits.
3. To study the molecular mechanisms by which the different types of interventions influence cognitive, emotional and brain benefits.
4. To study interventions-induced microbiome changes and to explain how these changes may induce inflammatory and immune responses that may contribute to cognitive, emotional and brain benefits.
5. To determine the demographic, clinical and genetic factors that may modulate cognitive, emotional and brain changes: baseline cognitive status; baseline cerebral status (atrophy, total intracranial volume); sex; age, educational level, intelligence.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 18-80 years old
* Ischemic or hemorrhagic stroke
* Stroke diagnoses between 3-60 months ago
* To have consent from a physician to engage in an exercise intervention
* Fluency in Catalan or Spanish (I.e., able to understand and speak)
* Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.

Exclusion Criteria:

* Cognitive impairment (MMSE \> 23)
* Severe aphasia (item 9 of the NIHSS scale ≥ 2)
* Severe sensory problems
* Other neurological conditions apart from stroke
* Severe pre-stroke psychiatric disorders (e.g., bipolar disorder, schizophrenia)
* History of alcohol or other toxic abuse

Exclusion criteria only for MRI examination:

* Claustrophobia
* Medical device (e.g., pacemaker implants, stents)
* Other metal objects in the body

Primary outcomes:
measure: Change in immediate verbal attention after receiving treatment
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Change in verbal digit working memory after receiving treatment
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Change in verbal memory after receiving treatment
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Change in visual memory after receiving treatment
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Change in executive function, verbal fluency after receiving treatment
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Change in executive function, inhibition after receiving treatment
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Change in executive function, set-switching task after receiving treatment
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Change in language, naming after receiving treatment
timeFrame: 3 months (at baseline, 3 months from baseline)
Secondary outcomes:
measure: Changes in psychological distress
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in depression and anxiety
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in wellbeing
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in Mindfulness
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in White matter integrity
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in Resting-state connectivity
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in brain volumetry
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Molecular changes: growth factors (BDNF, SDF1-a, VEGF-A, IGF-1, and NGF), cortisol, protein C reactive, IL-6 and homocysteine levels
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in Microbiota data
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in Sleep
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in Fitness
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in stroke specific quality of life
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in quality of life
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in mental fatigue
timeFrame: 3 months (at baseline, 3 months from baseline)
measure: Changes in physical activity:
timeFrame: 3 months (at baseline, 3 months from baseline)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Maria Mataro
Study officials:
affiliation: University of Barcelona
name: Maria Mataro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bermudo-Gallaguet A, Ariza M, Dacosta-Aguayo R, Agudelo D, Camins-Vila N, Boldo M, Carrera O, Vidal S, Ferrer-Uris B, Busquets A, Via M, Pera G, Caceres C, Gomis M, Garcia-Molina A, Tormos JM, Arrabe A, Diez G, Dura Mata MJ, Toran-Monserrat P, Soriano-Raya JJ, Domenech S, Perera-Lluna A, Erickson KI, Mataro M. 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. Front Aging Neurosci. 2022 Sep 29;14:936077. doi: 10.3389/fnagi.2022.936077. eCollection 2022.