Exercise the Mind and Brain. A Multimodal Intervention in Stroke
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 135
Summary
- Conditions
- Stroke
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Double (Investigator, Outcomes Assessor)Masking Description: The randomization sequence is concealed (blinded) from research personnel, so that the investigators are not aware of whether a particular subject has been randomized to one of the intervention groups or to the active control group.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The MindFit Project is a multicentric, prospective, parallel, single-blinded, randomized controlled trial with a sample of 135 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...
The MindFit Project is a multicentric, prospective, parallel, single-blinded, randomized controlled trial with a sample of 135 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=45) receives computer-based cognitive training (CCT) combined with a multicomponent physical exercise program. The second group (n=45) receives CCT combined with mindfulness-based stress reduction therapy. Finally, the third group (n=45), 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: 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. 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. To study the molecular mechanisms by which the different types of interventions influence cognitive, emotional and brain benefits. 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. 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.
Tracking Information
- NCT #
- NCT04759950
- Collaborators
- Fundació La Marató de TV3
- Germans Trias i Pujol Hospital
- Institut Guttmann
- Jordi Gol i Gurina Foundation
- University of Pittsburgh
- Investigators
- Principal Investigator: Maria Mataro, PhD University of Barcelona