Status:
COMPLETED
Exercise the Mind and Brain. A Multimodal Intervention in Stroke
Lead Sponsor:
University of Barcelona
Collaborating Sponsors:
Fundació La Marató de TV3
Germans Trias i Pujol Hospital
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
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 mec...
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 al...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2022
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04759950
Start Date
October 28 2020
End Date
January 30 2022
Last Update
March 2 2022
Active Locations (1)
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1
Maria Mataro
Barcelona, Spain