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Exercise the Mind and Brain. A Multimodal Intervention in Stroke (Mindfit)

1 marzo 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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:

  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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

141

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
      • Barcelona, Spagna
        • Maria Mataro

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Physical exercise & cognitive training group
The Physical exercise & cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.
Comportamentale: Multicomponent Physical Activity Program
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).
Comportamentale: Computerized Cognitive Training
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.
Sperimentale: Mindfulness & cognitive training group
The Mindfulness & cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.
Comportamentale: Computerized Cognitive Training
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.
Comportamentale: Mindfulness-Based Stress Reduction Program
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.
Comparatore attivo: Cognitive training group
The Cognitive training group, as an active control group, receives only computer-based cognitive training.
Comportamentale: Computerized Cognitive Training
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in immediate verbal attention after receiving treatment
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Forward Digit Span (WAIS III)
3 months (at baseline, 3 months from baseline)
Change in verbal digit working memory after receiving treatment
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Backward Digit Span (WAIS III)
3 months (at baseline, 3 months from baseline)
Change in verbal memory after receiving treatment
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Rey Auditory Learning Test
3 months (at baseline, 3 months from baseline)
Change in visual memory after receiving treatment
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Rey's Complex Figure Test
3 months (at baseline, 3 months from baseline)
Change in executive function, verbal fluency after receiving treatment
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Phonetic Fluency is measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animal
3 months (at baseline, 3 months from baseline)
Change in executive function, inhibition after receiving treatment
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Stroop Test
3 months (at baseline, 3 months from baseline)
Change in executive function, set-switching task after receiving treatment
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Trail Making Test
3 months (at baseline, 3 months from baseline)
Change in language, naming after receiving treatment
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Boston naming Test
3 months (at baseline, 3 months from baseline)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in psychological distress
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Clinical Outcomes in Routine Evaluation (CORE-OM)
3 months (at baseline, 3 months from baseline)
Changes in depression and anxiety
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Depression Anxiety Stress Scale (DASS-21)
3 months (at baseline, 3 months from baseline)
Changes in wellbeing
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Ryff Scales of Psychological Wellbeing.
3 months (at baseline, 3 months from baseline)
Changes in Mindfulness
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Mindful Attention Awareness Scale (MAAS)
3 months (at baseline, 3 months from baseline)
Changes in White matter integrity
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
White matter integrity: tractography
3 months (at baseline, 3 months from baseline)
Changes in Resting-state connectivity
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Resting state brain activity using fMRI
3 months (at baseline, 3 months from baseline)
Changes in brain volumetry
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Grey and white matter volume measured by MRI
3 months (at baseline, 3 months from baseline)
Molecular changes: growth factors (BDNF, SDF1-a, VEGF-A, IGF-1, and NGF), cortisol, protein C reactive, IL-6 and homocysteine levels
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Quantification of different biomarkers from blood samples.
3 months (at baseline, 3 months from baseline)
Changes in Microbiota data
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Bacterial composition of stool samples in terms of relative abundance
3 months (at baseline, 3 months from baseline)
Changes in Sleep
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Pittsburgh Sleep Quality Index (PSQI)
3 months (at baseline, 3 months from baseline)
Changes in Fitness
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Senior Fitness Test (SFT)
3 months (at baseline, 3 months from baseline)
Changes in stroke specific quality of life
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Stroke-specific Quality of Life Scale (ECVI-38)
3 months (at baseline, 3 months from baseline)
Changes in quality of life
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
World Health Organization Quality of Life (WHOQOL-BREF)
3 months (at baseline, 3 months from baseline)
Changes in mental fatigue
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Fatigue Assessment Scale (FAS)
3 months (at baseline, 3 months from baseline)
Changes in physical activity:
Lasso di tempo: 3 months (at baseline, 3 months from baseline)
Spanish version of the reduced Minnesota leisure-time physical and activity questionnaire (VREM)
3 months (at baseline, 3 months from baseline)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Barcelona

Collaboratori

University of Pittsburgh
Germans Trias i Pujol Hospital
Fundació La Marató de TV3
Institut Guttmann
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Investigatori

  • Investigatore principale: Maria Mataró, PhD, University of Barcelona

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 ottobre 2020

Completamento primario (Effettivo)

30 luglio 2021

Completamento dello studio (Effettivo)

30 gennaio 2022

Date di iscrizione allo studio

Primo inviato

31 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

15 febbraio 2021

Primo Inserito (Effettivo)

18 febbraio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • University of Barcelona
  • 201717.30.31.32 (Altro numero di sovvenzione/finanziamento: La Marato de TV3)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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