Stroke
Conditions
Keywords
Neuroplasticity, stroke, neuroprotection, physical exercise, cognitive training, mindfulness, neuroimaging, intervention, randomization, blind
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMulticomponent 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).
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.
BEHAVIORALComputerized 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.
Sponsors
Germans Trias i Pujol Hospital
Fundació La Marató de TV3
Institut Guttmann
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
University of Pittsburgh
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The randomization sequence is concealed (blinded) from research personnel, so that the investigators are not aware of whether a particular subject has been randomized to one of the intervention groups or to the active control group.
Intervention model description
141 participants at 3 to 60 months after stroke are randomly allocated to one of three arms: 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in immediate verbal attention after receiving treatment | 3 months (at baseline, 3 months from baseline) | Forward Digit Span (WAIS III) |
| Change in verbal digit working memory after receiving treatment | 3 months (at baseline, 3 months from baseline) | Backward Digit Span (WAIS III) |
| Change in verbal memory after receiving treatment | 3 months (at baseline, 3 months from baseline) | Rey Auditory Learning Test |
| Change in visual memory after receiving treatment | 3 months (at baseline, 3 months from baseline) | Rey's Complex Figure Test |
| Change in executive function, verbal fluency after receiving treatment | 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 |
| Change in executive function, inhibition after receiving treatment | 3 months (at baseline, 3 months from baseline) | Stroop Test |
| Change in executive function, set-switching task after receiving treatment | 3 months (at baseline, 3 months from baseline) | Trail Making Test |
| Change in language, naming after receiving treatment | 3 months (at baseline, 3 months from baseline) | Boston naming Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mindfulness | 3 months (at baseline, 3 months from baseline) | Mindful Attention Awareness Scale (MAAS) |
| Changes in White matter integrity | 3 months (at baseline, 3 months from baseline) | White matter integrity: tractography |
| Changes in Resting-state connectivity | 3 months (at baseline, 3 months from baseline) | Resting state brain activity using fMRI |
| Changes in brain volumetry | 3 months (at baseline, 3 months from baseline) | Grey and white matter volume measured by MRI |
| Molecular changes: growth factors (BDNF, SDF1-a, VEGF-A, IGF-1, and NGF), cortisol, protein C reactive, IL-6 and homocysteine levels | 3 months (at baseline, 3 months from baseline) | Quantification of different biomarkers from blood samples. |
| Changes in Microbiota data | 3 months (at baseline, 3 months from baseline) | Bacterial composition of stool samples in terms of relative abundance |
| Changes in Sleep | 3 months (at baseline, 3 months from baseline) | Pittsburgh Sleep Quality Index (PSQI) |
| Changes in Fitness | 3 months (at baseline, 3 months from baseline) | Senior Fitness Test (SFT) |
| Changes in stroke specific quality of life | 3 months (at baseline, 3 months from baseline) | Stroke-specific Quality of Life Scale (ECVI-38) |
| Changes in quality of life | 3 months (at baseline, 3 months from baseline) | World Health Organization Quality of Life (WHOQOL-BREF) |
| Changes in mental fatigue | 3 months (at baseline, 3 months from baseline) | Fatigue Assessment Scale (FAS) |
| Changes in physical activity: | 3 months (at baseline, 3 months from baseline) | Spanish version of the reduced Minnesota leisure-time physical and activity questionnaire (VREM) |
| Changes in psychological distress | 3 months (at baseline, 3 months from baseline) | Clinical Outcomes in Routine Evaluation (CORE-OM) |
| Changes in depression and anxiety | 3 months (at baseline, 3 months from baseline) | Depression Anxiety Stress Scale (DASS-21) |
| Changes in wellbeing | 3 months (at baseline, 3 months from baseline) | Ryff Scales of Psychological Wellbeing. |
Countries
Spain
Outcome results
None listed