Exercise the Mind and Brain. A Multimodal Intervention in Stroke (Mindfit)
1 de marzo de 2022 actualizado por: Maria Mataro Serrat, University of Barcelona
Effects of Combined Therapies of Physical Exercise, Mindfulness and Cognitive Stimulation on Cognition and Neuroplasticity in Chronic Stroke Patients: A Randomized Controlled Trial
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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:
- 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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
141
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Barcelona, España
- Maria Mataro
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Physical exercise & cognitive training group
The Physical exercise & cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.
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The proposed physical exercise intervention follows the American College of Sports Medicine (ACSM, 2017) and the American Stroke Association (Billinger et al., 2014) recommendations for stroke patients.
The five weekly 45-minute sessions are divided into (1) three sessions guided and supervised telematically by a physical exercise specialist and a physiotherapist; (2) and two autonomous exercise sessions.
The supervised sessions include exercises to work aerobic capacity, muscle strength and endurance, flexibility, agility, and balance.
The intensity of these exercises is prescribed individually according to each participant's initial level and are gradually increased as the program progresses.
Participants are encouraged to walk at a similar intensity on autonomous physical exercise days as performed in the guided sessions (moderate intensity), based on the Borg scale of perceived exertion (Borg, 1982).
An accredited neuropsychologist programs and supervises the computerized cognitive training through the Guttmann Neuropersonal Trainer (GNPT®) platform.
The 12-week program consists of five sessions a week (45 minutes each) that include personalized activities planned to stimulate executive functioning, attention, processing speed, and memory.
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Experimental: Mindfulness & cognitive training group
The Mindfulness & cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.
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An accredited neuropsychologist programs and supervises the computerized cognitive training through the Guttmann Neuropersonal Trainer (GNPT®) platform.
The 12-week program consists of five sessions a week (45 minutes each) that include personalized activities planned to stimulate executive functioning, attention, processing speed, and memory.
This intervention follows an adaptation of the scheme and instructions of the official Mindfulness-Based Stress Reduction (MBSR) program designed by Jon Kabat-Zinn.
It includes body scanning, sitting meditation, and gentle hatha yoga techniques.
An accredited mindfulness instructor leads the 12-week online program, which comprises a presentation session, followed by eight intervention sessions (once a week, lasting 2.5 hours) and an intensive practice session interspersed between sessions six and seven.
Apart from the supervised session, the therapist asks participants to carry out some independent practice daily.
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Comparador activo: Cognitive training group
The Cognitive training group, as an active control group, receives only computer-based cognitive training.
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An accredited neuropsychologist programs and supervises the computerized cognitive training through the Guttmann Neuropersonal Trainer (GNPT®) platform.
The 12-week program consists of five sessions a week (45 minutes each) that include personalized activities planned to stimulate executive functioning, attention, processing speed, and memory.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in immediate verbal attention after receiving treatment
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Forward Digit Span (WAIS III)
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3 months (at baseline, 3 months from baseline)
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Change in verbal digit working memory after receiving treatment
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Backward Digit Span (WAIS III)
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3 months (at baseline, 3 months from baseline)
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Change in verbal memory after receiving treatment
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Rey Auditory Learning Test
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3 months (at baseline, 3 months from baseline)
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Change in visual memory after receiving treatment
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Rey's Complex Figure Test
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3 months (at baseline, 3 months from baseline)
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Change in executive function, verbal fluency after receiving treatment
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Phonetic Fluency is measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animal
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3 months (at baseline, 3 months from baseline)
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Change in executive function, inhibition after receiving treatment
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Stroop Test
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3 months (at baseline, 3 months from baseline)
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Change in executive function, set-switching task after receiving treatment
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Trail Making Test
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3 months (at baseline, 3 months from baseline)
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Change in language, naming after receiving treatment
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Boston naming Test
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3 months (at baseline, 3 months from baseline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in psychological distress
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Clinical Outcomes in Routine Evaluation (CORE-OM)
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3 months (at baseline, 3 months from baseline)
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Changes in depression and anxiety
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Depression Anxiety Stress Scale (DASS-21)
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3 months (at baseline, 3 months from baseline)
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Changes in wellbeing
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Ryff Scales of Psychological Wellbeing.
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3 months (at baseline, 3 months from baseline)
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Changes in Mindfulness
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Mindful Attention Awareness Scale (MAAS)
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3 months (at baseline, 3 months from baseline)
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Changes in White matter integrity
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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White matter integrity: tractography
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3 months (at baseline, 3 months from baseline)
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Changes in Resting-state connectivity
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Resting state brain activity using fMRI
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3 months (at baseline, 3 months from baseline)
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Changes in brain volumetry
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Grey and white matter volume measured by MRI
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3 months (at baseline, 3 months from baseline)
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Molecular changes: growth factors (BDNF, SDF1-a, VEGF-A, IGF-1, and NGF), cortisol, protein C reactive, IL-6 and homocysteine levels
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Quantification of different biomarkers from blood samples.
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3 months (at baseline, 3 months from baseline)
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Changes in Microbiota data
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Bacterial composition of stool samples in terms of relative abundance
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3 months (at baseline, 3 months from baseline)
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Changes in Sleep
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Pittsburgh Sleep Quality Index (PSQI)
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3 months (at baseline, 3 months from baseline)
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Changes in Fitness
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Senior Fitness Test (SFT)
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3 months (at baseline, 3 months from baseline)
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Changes in stroke specific quality of life
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Stroke-specific Quality of Life Scale (ECVI-38)
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3 months (at baseline, 3 months from baseline)
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Changes in quality of life
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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World Health Organization Quality of Life (WHOQOL-BREF)
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3 months (at baseline, 3 months from baseline)
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Changes in mental fatigue
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Fatigue Assessment Scale (FAS)
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3 months (at baseline, 3 months from baseline)
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Changes in physical activity:
Periodo de tiempo: 3 months (at baseline, 3 months from baseline)
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Spanish version of the reduced Minnesota leisure-time physical and activity questionnaire (VREM)
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3 months (at baseline, 3 months from baseline)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maria Mataró, PhD, University of Barcelona
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de octubre de 2020
Finalización primaria (Actual)
30 de julio de 2021
Finalización del estudio (Actual)
30 de enero de 2022
Fechas de registro del estudio
Enviado por primera vez
31 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
15 de febrero de 2021
Publicado por primera vez (Actual)
18 de febrero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
1 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- University of Barcelona
- 201717.30.31.32 (Otro número de subvención/financiamiento: La Marato de TV3)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .