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

1 marca 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

141

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Hiszpania
      • Barcelona, Hiszpania
        • Maria Mataro

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Physical exercise & cognitive training group
The Physical exercise & cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.
Behawioralne: 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).
Behawioralne: 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.
Eksperymentalny: Mindfulness & cognitive training group
The Mindfulness & cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.
Behawioralne: 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.
Behawioralne: 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.
Aktywny komparator: Cognitive training group
The Cognitive training group, as an active control group, receives only computer-based cognitive training.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in immediate verbal attention after receiving treatment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 3 months (at baseline, 3 months from baseline)
Boston naming Test
3 months (at baseline, 3 months from baseline)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Changes in psychological distress
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 3 months (at baseline, 3 months from baseline)
Ryff Scales of Psychological Wellbeing.
3 months (at baseline, 3 months from baseline)
Changes in Mindfulness
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 3 months (at baseline, 3 months from baseline)
Pittsburgh Sleep Quality Index (PSQI)
3 months (at baseline, 3 months from baseline)
Changes in Fitness
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 3 months (at baseline, 3 months from baseline)
Fatigue Assessment Scale (FAS)
3 months (at baseline, 3 months from baseline)
Changes in physical activity:
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Barcelona

Współpracownicy

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

Śledczy

  • Główny śledczy: Maria Mataró, PhD, University of Barcelona

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

28 października 2020

Zakończenie podstawowe (Rzeczywisty)

30 lipca 2021

Ukończenie studiów (Rzeczywisty)

30 stycznia 2022

Daty rejestracji na studia

Pierwszy przesłany

31 grudnia 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 lutego 2021

Pierwszy wysłany (Rzeczywisty)

18 lutego 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 marca 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 marca 2022

Ostatnia weryfikacja

1 marca 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • University of Barcelona
  • 201717.30.31.32 (Inny numer grantu/finansowania: La Marato de TV3)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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