Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759950
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-12-31
Brief Title:
Exercise the Mind and Brain A Multimodal Intervention in Stroke
Sponsor:
University of Barcelona
Organization:
University of Barcelona
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mindfit
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 111 ratio created with a random sequence generator software
The first group n47 receives computer-based cognitive training CCT combined with a multicomponent physical exercise program The second group n47 receives CCT combined with mindfulness-based stress reduction therapy Finally the third group n47 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
The first group n47 receives computer-based cognitive training CCT combined with a multicomponent physical exercise program The second group n47 receives CCT combined with mindfulness-based stress reduction therapy Finally the third group n47 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 201717303132 | OTHER_GRANT | La Marato de TV3 | None |