Exercise the Mind and Brain. A Multimodal Intervention in Stroke (Mindfit)

University of Barcelona

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Mindfulness-Based Stress Reduction Program; Behavioral: Computerized Cognitive Training; Behavioral: Multicomponent Physical Activity Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04759950

201717.30.31.32 (Other Grant/Funding Number)

University of Barcelona

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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141 participants in 3 patient groups

Physical exercise & cognitive training group

Experimental group

Description:

The Physical exercise \& cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.

Treatment:

Behavioral: Computerized Cognitive Training

Behavioral: Multicomponent Physical Activity Program

Mindfulness & cognitive training group

Experimental group

Description:

The Mindfulness \& cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.

Treatment:

Behavioral: Computerized Cognitive Training

Behavioral: Mindfulness-Based Stress Reduction Program

Cognitive training group

Active Comparator group

Description:

The Cognitive training group, as an active control group, receives only computer-based cognitive training.

Treatment:

Behavioral: Computerized Cognitive Training