Exercise the Mind and Brain. A Multimodal Intervention in Stroke (Mindfit)
1 марта 2022 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
141
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Barcelona, Испания
- Maria Mataro
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 80 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Экспериментальный: 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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Активный компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in immediate verbal attention after receiving treatment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 3 months (at baseline, 3 months from baseline)
|
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
Временное ограничение: 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
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3 months (at baseline, 3 months from baseline)
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Change in executive function, inhibition after receiving treatment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Changes in psychological distress
Временное ограничение: 3 months (at baseline, 3 months from baseline)
|
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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:
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Maria Mataró, PhD, University of Barcelona
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
28 октября 2020 г.
Первичное завершение (Действительный)
30 июля 2021 г.
Завершение исследования (Действительный)
30 января 2022 г.
Даты регистрации исследования
Первый отправленный
31 декабря 2020 г.
Впервые представлено, что соответствует критериям контроля качества
15 февраля 2021 г.
Первый опубликованный (Действительный)
18 февраля 2021 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
2 марта 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
1 марта 2022 г.
Последняя проверка
1 марта 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- University of Barcelona
- 201717.30.31.32 (Другой номер гранта/финансирования: La Marato de TV3)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .