Exercise the Mind and Brain. A Multimodal Intervention in Stroke (Mindfit)
1 mars 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
141
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Barcelona, Espagne
- Maria Mataro
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in immediate verbal attention after receiving treatment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in psychological distress
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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:
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Maria Mataró, PhD, University of Barcelona
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
28 octobre 2020
Achèvement primaire (Réel)
30 juillet 2021
Achèvement de l'étude (Réel)
30 janvier 2022
Dates d'inscription aux études
Première soumission
31 décembre 2020
Première soumission répondant aux critères de contrôle qualité
15 février 2021
Première publication (Réel)
18 février 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 mars 2022
Dernière vérification
1 mars 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- University of Barcelona
- 201717.30.31.32 (Autre subvention/numéro de financement: La Marato de TV3)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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