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

1. März 2022 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

141

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Spanien
      • Barcelona, Spanien
        • Maria Mataro

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Physical exercise & cognitive training group
The Physical exercise & cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.
Verhalten: 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).
Verhalten: 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.
Experimental: Mindfulness & cognitive training group
The Mindfulness & cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.
Verhalten: 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.
Verhalten: 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.
Aktiver Komparator: Cognitive training group
The Cognitive training group, as an active control group, receives only computer-based cognitive training.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in immediate verbal attention after receiving treatment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3 months (at baseline, 3 months from baseline)
Boston naming Test
3 months (at baseline, 3 months from baseline)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in psychological distress
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3 months (at baseline, 3 months from baseline)
Ryff Scales of Psychological Wellbeing.
3 months (at baseline, 3 months from baseline)
Changes in Mindfulness
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3 months (at baseline, 3 months from baseline)
Pittsburgh Sleep Quality Index (PSQI)
3 months (at baseline, 3 months from baseline)
Changes in Fitness
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3 months (at baseline, 3 months from baseline)
Fatigue Assessment Scale (FAS)
3 months (at baseline, 3 months from baseline)
Changes in physical activity:
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Barcelona

Mitarbeiter

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

Ermittler

  • Hauptermittler: Maria Mataró, PhD, University of Barcelona

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Oktober 2020

Primärer Abschluss (Tatsächlich)

30. Juli 2021

Studienabschluss (Tatsächlich)

30. Januar 2022

Studienanmeldedaten

Zuerst eingereicht

31. Dezember 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Februar 2021

Zuerst gepostet (Tatsächlich)

18. Februar 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. März 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. März 2022

Zuletzt verifiziert

1. März 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • University of Barcelona
  • 201717.30.31.32 (Andere Zuschuss-/Finanzierungsnummer: La Marato de TV3)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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