Exercise the Mind and Brain. A Multimodal Intervention in Stroke

NCT ID: NCT04759950

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2022-01-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physical exercise & cognitive training group

The Physical exercise \& cognitive training group receives a multicomponent physical exercise program combined with computer-based cognitive training.

Group Type: EXPERIMENTAL

Multicomponent Physical Activity Program

Intervention Type: BEHAVIORAL

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).

Computerized Cognitive Training

Intervention Type: BEHAVIORAL

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.

Mindfulness & cognitive training group

The Mindfulness \& cognitive training group receives mindfulness-based stress reduction therapy combined with computer-based cognitive training.

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction Program

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Cognitive training group

The Cognitive training group, as an active control group, receives only computer-based cognitive training.

Group Type: ACTIVE_COMPARATOR

Computerized Cognitive Training

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Claustrophobia
• Medical device (e.g., pacemaker implants, stents)
• Other metal objects in the body

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació La Marató de TV3

OTHER

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: collaborator

Institut Guttmann

OTHER

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Maria Mataro Serrat

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Mataro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

Maria Mataro

Barcelona, , Spain

Countries

Spain

References

Bermudo-Gallaguet A, Ariza M, Agudelo D, Camins-Vila N, Boldo M, Ferrer-Uris B, Busquets A, Pera G, Caceres C, Gomis M, Dacosta-Aguayo R, Clemente IC, Garcia-Molina A, Mata MJD, Toran-Monserrat P, Erickson KI, Mataro M. Effects of mindfulness and exercise on cognition and emotion in adults with mild deficits in the chronic post-stroke phase: A randomized controlled trial. Ann Phys Rehabil Med. 2025 Aug 21;68(7):102008. doi: 10.1016/j.rehab.2025.102008. Online ahead of print.

Reference Type: DERIVED

PMID: 40845631 (View on PubMed)

Bermudo-Gallaguet A, Ariza M, Dacosta-Aguayo R, Agudelo D, Camins-Vila N, Boldo M, Carrera O, Vidal S, Ferrer-Uris B, Busquets A, Via M, Pera G, Caceres C, Gomis M, Garcia-Molina A, Tormos JM, Arrabe A, Diez G, Dura Mata MJ, Toran-Monserrat P, Soriano-Raya JJ, Domenech S, Perera-Lluna A, Erickson KI, Mataro M. Effects and mechanisms of mindfulness training and physical exercise on cognition, emotional wellbeing, and brain outcomes in chronic stroke patients: Study protocol of the MindFit project randomized controlled trial. Front Aging Neurosci. 2022 Sep 29;14:936077. doi: 10.3389/fnagi.2022.936077. eCollection 2022.

Reference Type: DERIVED

PMID: 36248000 (View on PubMed)

Other Identifiers

201717.30.31.32

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

University of Barcelona

Identifier Type: -

Identifier Source: org_study_id