Exercise the Mind and Brain. A Multimodal Intervention in Stroke

Stroke Clinical Trial

— Mindfit  

Official title:

Effects of Combined Therapies of Physical Exercise, Mindfulness and Cognitive Stimulation on Cognition and Neuroplasticity in Chronic Stroke Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759950
• Other study ID #: University of Barcelona
• Secondary ID: 201717.30.31.32
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2022
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 30, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• 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).
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Maria Mataro	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
University of Barcelona	Fundació La Marató de TV3, Germans Trias i Pujol Hospital, Institut Guttmann, Jordi Gol i Gurina Foundation, University of Pittsburgh

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in immediate verbal attention after receiving treatment	Forward Digit Span (WAIS III)	3 months (at baseline, 3 months from baseline)
Primary	Change in verbal digit working memory after receiving treatment	Backward Digit Span (WAIS III)	3 months (at baseline, 3 months from baseline)
Primary	Change in verbal memory after receiving treatment	Rey Auditory Learning Test	3 months (at baseline, 3 months from baseline)
Primary	Change in visual memory after receiving treatment	Rey's Complex Figure Test	3 months (at baseline, 3 months from baseline)
Primary	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	3 months (at baseline, 3 months from baseline)
Primary	Change in executive function, inhibition after receiving treatment	Stroop Test	3 months (at baseline, 3 months from baseline)
Primary	Change in executive function, set-switching task after receiving treatment	Trail Making Test	3 months (at baseline, 3 months from baseline)
Primary	Change in language, naming after receiving treatment	Boston naming Test	3 months (at baseline, 3 months from baseline)
Secondary	Changes in psychological distress	Clinical Outcomes in Routine Evaluation (CORE-OM)	3 months (at baseline, 3 months from baseline)
Secondary	Changes in depression and anxiety	Depression Anxiety Stress Scale (DASS-21)	3 months (at baseline, 3 months from baseline)
Secondary	Changes in wellbeing	Ryff Scales of Psychological Wellbeing.	3 months (at baseline, 3 months from baseline)
Secondary	Changes in Mindfulness	Mindful Attention Awareness Scale (MAAS)	3 months (at baseline, 3 months from baseline)
Secondary	Changes in White matter integrity	White matter integrity: tractography	3 months (at baseline, 3 months from baseline)
Secondary	Changes in Resting-state connectivity	Resting state brain activity using fMRI	3 months (at baseline, 3 months from baseline)
Secondary	Changes in brain volumetry	Grey and white matter volume measured by MRI	3 months (at baseline, 3 months from baseline)
Secondary	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.	3 months (at baseline, 3 months from baseline)
Secondary	Changes in Microbiota data	Bacterial composition of stool samples in terms of relative abundance	3 months (at baseline, 3 months from baseline)
Secondary	Changes in Sleep	Pittsburgh Sleep Quality Index (PSQI)	3 months (at baseline, 3 months from baseline)
Secondary	Changes in Fitness	Senior Fitness Test (SFT)	3 months (at baseline, 3 months from baseline)
Secondary	Changes in stroke specific quality of life	Stroke-specific Quality of Life Scale (ECVI-38)	3 months (at baseline, 3 months from baseline)
Secondary	Changes in quality of life	World Health Organization Quality of Life (WHOQOL-BREF)	3 months (at baseline, 3 months from baseline)
Secondary	Changes in mental fatigue	Fatigue Assessment Scale (FAS)	3 months (at baseline, 3 months from baseline)
Secondary	Changes in physical activity:	Spanish version of the reduced Minnesota leisure-time physical and activity questionnaire (VREM)	3 months (at baseline, 3 months from baseline)