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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
141
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).
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.
Maria Mataro
Barcelona, Spain
Change in immediate verbal attention after receiving treatment
Forward Digit Span (WAIS III)
Time frame: 3 months (at baseline, 3 months from baseline)
Change in verbal digit working memory after receiving treatment
Backward Digit Span (WAIS III)
Time frame: 3 months (at baseline, 3 months from baseline)
Change in verbal memory after receiving treatment
Rey Auditory Learning Test
Time frame: 3 months (at baseline, 3 months from baseline)
Change in visual memory after receiving treatment
Rey's Complex Figure Test
Time frame: 3 months (at baseline, 3 months from baseline)
Change in executive function, verbal fluency after receiving treatment
Phonetic Fluency is measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animal
Time frame: 3 months (at baseline, 3 months from baseline)
Change in executive function, inhibition after receiving treatment
Stroop Test
Time frame: 3 months (at baseline, 3 months from baseline)
Change in executive function, set-switching task after receiving treatment
Trail Making Test
Time frame: 3 months (at baseline, 3 months from baseline)
Change in language, naming after receiving treatment
Boston naming Test
Time frame: 3 months (at baseline, 3 months from baseline)
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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.
Changes in psychological distress
Clinical Outcomes in Routine Evaluation (CORE-OM)
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in depression and anxiety
Depression Anxiety Stress Scale (DASS-21)
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in wellbeing
Ryff Scales of Psychological Wellbeing.
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in Mindfulness
Mindful Attention Awareness Scale (MAAS)
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in White matter integrity
White matter integrity: tractography
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in Resting-state connectivity
Resting state brain activity using fMRI
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in brain volumetry
Grey and white matter volume measured by MRI
Time frame: 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
Quantification of different biomarkers from blood samples.
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in Microbiota data
Bacterial composition of stool samples in terms of relative abundance
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in Sleep
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in Fitness
Senior Fitness Test (SFT)
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in stroke specific quality of life
Stroke-specific Quality of Life Scale (ECVI-38)
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in quality of life
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in mental fatigue
Fatigue Assessment Scale (FAS)
Time frame: 3 months (at baseline, 3 months from baseline)
Changes in physical activity:
Spanish version of the reduced Minnesota leisure-time physical and activity questionnaire (VREM)
Time frame: 3 months (at baseline, 3 months from baseline)